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Pirtea M, Balint O, Secoșan C, Costăchescu D, Dabîca A, Navolan D. Quality of Life Assessment After Pelvic Prolapse Surgery With and Without Mesh: A Literature Review. J Clin Med 2025; 14:1325. [PMID: 40004855 PMCID: PMC11856146 DOI: 10.3390/jcm14041325] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2025] [Revised: 02/01/2025] [Accepted: 02/10/2025] [Indexed: 02/27/2025] Open
Abstract
Background/Objectives: The quality of life (QoL) in patients undergoing pelvic prolapse surgery is a critical area of research in urogynecology. Pelvic organ prolapse (POP) is a prevalent condition affecting a significant number of women, leading to various physical and psychological symptoms that can severely impact their quality of life. Surgical intervention aims not only to correct the anatomical defects but also to enhance the overall well-being of patients. Methods: A comprehensive literature search in the main databases was conducted for studies evaluating quality of life after surgical treatment using techniques with and without mesh. Results: A total of 35 studies met the inclusion criteria, involving a total of 4603 patients. Twenty-two distinct patient-reported outcomes (PRO) questionnaires have been identified as post-surgical QoL assessment tools. Conclusions: Quality of life is significantly improved by surgical treatment of pelvic organ prolapse. Post-surgical PRO scores do not seem to be influenced by the surgical technique used, with no significant differences between methods using mesh or not.
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Affiliation(s)
- Marilena Pirtea
- Doctoral School, University of Medicine and Pharmacy “Victor Babeș”, 300041 Timișoara, Romania; (M.P.); (A.D.)
| | - Oana Balint
- Obstetrics-Gynecology I Department, University of Medicine and Pharmacy “Victor Babeș”, 300041 Timișoara, Romania; (C.S.); (D.N.)
| | - Cristina Secoșan
- Obstetrics-Gynecology I Department, University of Medicine and Pharmacy “Victor Babeș”, 300041 Timișoara, Romania; (C.S.); (D.N.)
| | - Dan Costăchescu
- Radiology Department, University of Medicine and Pharmacy “Victor Babeș”, 300041 Timișoara, Romania;
| | - Alexandru Dabîca
- Doctoral School, University of Medicine and Pharmacy “Victor Babeș”, 300041 Timișoara, Romania; (M.P.); (A.D.)
| | - Dan Navolan
- Obstetrics-Gynecology I Department, University of Medicine and Pharmacy “Victor Babeș”, 300041 Timișoara, Romania; (C.S.); (D.N.)
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Yeung E, Baessler K, Christmann-Schmid C, Haya N, Chen Z, Wallace SA, Mowat A, Maher C. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev 2024; 3:CD012079. [PMID: 38477494 PMCID: PMC10936147 DOI: 10.1002/14651858.cd012079.pub2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/14/2024]
Abstract
BACKGROUND Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016. OBJECTIVES To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse. SEARCH METHODS We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and two clinical trials registers (March 2022). SELECTION CRITERIA Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue). DATA COLLECTION AND ANALYSIS Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination. MAIN RESULTS We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate). Transvaginal permanent mesh versus native tissue repair Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I2 = 34%; 17 studies, 2932 women; moderate-certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair. Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I2 = 35%; 17 studies, 2485 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I2 = 0%; 13 studies, 2206 women; moderate-certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I2 = 54%; 27 studies, 3916 women; low-certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs. Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I2 = 84%; 25 studies, 3680 women; very low-certainty evidence). Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I2 = 0%; 17 studies, 2001 women; moderate-certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I2 = 0%; 14 studies, 1997 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I2 = 27%; 16 studies, 1308 women; moderate-certainty evidence). There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data. Transvaginal absorbable mesh versus native tissue repair There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women). The effect of either form of repair was uncertain for bladder-related outcomes, dyspareunia, and quality of life. Transvaginal biological graft versus native tissue repair There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I2 = 0%; 8 studies, 1374 women; moderate-certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I2 = 0%; 6 studies, 899 women; moderate-certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I2 = 53%; 9 studies, 1278 women; low-certainty evidence). There was no evidence of a difference between the groups for dyspareunia or quality of life. Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis. AUTHORS' CONCLUSIONS While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence. While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3- to 10-year outcomes. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk-benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations. Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.
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Affiliation(s)
- Ellen Yeung
- Royal Brisbane and Women's Hospital, Brisbane, Australia
- Gold Coast Health, Gold Coast, Australia
| | | | | | - Nir Haya
- Rambam Medical Centre, and Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
| | | | - Sheila A Wallace
- Evidence Synthesis Group, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
| | - Alex Mowat
- Greenslopes Hospital, Brisbane, Australia
| | - Christopher Maher
- Wesley and Royal Brisbane and Women's Hospitals, Brisbane, Australia
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Banakhevych R, Akymova K, Pariienko K, Nechaiev V. Prevention of complications of surgical treatment of stage III-IV cystocele using light polypropylene mesh. Urologia 2024; 91:212-219. [PMID: 37606212 DOI: 10.1177/03915603231193059] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/23/2023]
Abstract
OBJECTIVE The purpose of study was to report the subjective and objective results of different methods of surgical treatment of cystocele using the transvaginal Mesh-system. METHODOLOGY A prospective study was conducted from January 2017 to December 2020 comparing anterior colporrhaphy with vaginal mesh and two distinct types of vaginal wall repair sutures in the surgical treatment of cystocele. The primary endpoint was the incidence rate of vaginal wall erosion complications 12 months after surgery. Secondary endpoints were anatomic outcomes, TVM-related morbidity, and patient satisfaction measured using validated questionnaires. RESULTS In total, 102 patients with stage III-IV cystocele and the average age of 67.2 ± 3.1 years (age range of 47-79 years old) took part in the study. Of the 102 women initially enrolled, 102 (100%) were successfully followed up 12 months after primary surgery. The primary result, the objective erosion development, was radically different in the comparison groups (1.6% against 23.5%, respectively). Analysis of the improved method of operative treatment showed a prominent level of positive, uncomplicated, surgery results of 98.4% (60/61). The anatomic success rate of recovery from cystocele was 99.9% (101/102) 12 months after surgery. CONCLUSION The suggested method of restoring the anterior vaginal wall in stage III-IV isolated cystocele without signs of incomplete and complete prolapse of the uterus showed a radically positive result. The number of complications was relatively high in the comparison group, but no difference was observed in satisfaction with the anatomical results of the surgery. The percentage of the vaginal wall erosion when using a single-layer suture is 23.5%, when using a two-layer suture is 1.6.
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Affiliation(s)
- Roman Banakhevych
- Department of Obstetrics and Gynecology, Dnipro State Medical University, Dnipro, Ukraine
| | - Klavdiia Akymova
- Department of Obstetrics and Gynecology, Dnipro State Medical University, Dnipro, Ukraine
| | - Kateryna Pariienko
- Department of Obstetrics and Gynecology, Dnipro State Medical University, Dnipro, Ukraine
| | - Vsevolod Nechaiev
- Department of Obstetrics, Gynecology and Perinatology, Dnipro State Medical University, Dnipro, Ukraine
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Ramadan DT, Elhefnawy AS, Wadie BS. The use of midurethral sling in the correction of low-stage cystoceles: a prospective randomized trial. Int Urogynecol J 2024; 35:199-205. [PMID: 38047947 PMCID: PMC10810917 DOI: 10.1007/s00192-023-05691-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2023] [Accepted: 10/31/2023] [Indexed: 12/05/2023]
Abstract
INTRODUCTION AND HYPOTHESIS The objective was to assess whether midurethral slings (MUS) can improve both stress urinary incontinence (SUI) and cystoceles. MUS with anterior colporrhaphy (AC) as a treatment for SUI with cystocele is more invasive and carries greater risk than MUS alone. METHODS This is a prospective randomized study involving women with stage 1 or 2 cystocele and SUI, who were > 21 years of age, who had had no previous surgery for SUI. Predominant SUI, symptomatic anterior pelvic organ prolapse, and informed consent were mandatory. Patients were randomized as to whether AC had been performed. The sling procedure was left to the surgeon's discretion: pubovaginal sling, tension-free vaginal tape, or trans-obturator tape. Success was defined as a negative stress test and no evidence of cystocele upon local examination. RESULTS Ninety-eight patients were enrolled, 48 underwent MUS, and 50 underwent MUS and AC. Mean age ± SD was 44.96 ± 8.13 years. Baseline characteristics were similar. Operative time and blood loss were significantly higher in the MUS/AC group (p = 0.01 and 0.02 respectively). At 3 months, success was 79.1% and 77.8% in the MUS and MUS/AC groups respectively. This was maintained until 6 months (79.1% and 77.8% respectively). At 1 year, the results were comparable with success rates of 96.2% and 87.0% in the MUS and MUS and AC groups respectively. Symptom scores were comparable at 6- and 12-month evaluations. CONCLUSION Midurethral slings correct symptomatic stage 1 or 2 cystoceles without the need for AC, which carries the risk of a significantly longer procedure and more significant blood loss.
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Affiliation(s)
- Diaeldin T Ramadan
- Urology and Nephrology Center, Mansoura University, Gomhorria Street, Mansoura, 35516, Egypt
| | - Ahmed S Elhefnawy
- Urology and Nephrology Center, Mansoura University, Gomhorria Street, Mansoura, 35516, Egypt
| | - Bassem S Wadie
- Urology and Nephrology Center, Mansoura University, Gomhorria Street, Mansoura, 35516, Egypt.
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Lin CJ, Liu CK, Hsieh HY, Chen MJ, Tsai CP. Modified Vaginal Mesh Procedure with DynaMesh ®-PR4 for the Treatment of Anterior/Apical Vaginal Prolapse. Diagnostics (Basel) 2023; 13:2991. [PMID: 37761358 PMCID: PMC10528822 DOI: 10.3390/diagnostics13182991] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2023] [Revised: 09/14/2023] [Accepted: 09/15/2023] [Indexed: 09/29/2023] Open
Abstract
(1) Background: Treating female pelvic organ prolapse (POP) is challenging. Surgical meshes have been used in transvaginal surgeries since the 1990s, but complications such as mesh exposure and infection have been reported. Polyvinylidene fluoride (PVDF) mesh, known for its stability and non-reactive properties, has shown promise in urogynecological surgeries. (2) Methods: A retrospective analysis was conducted on 27 patients who underwent a modified PVDF vaginal mesh repair procedure using DynaMesh®-PR4 and combined trans-obturator and sacrospinous fixation techniques. Additional surgeries were performed as needed. (3) Results: The mean operation time was 56.7 min, and the mean blood loss was 66.7 mL. The average hospitalization period was 4.2 days with Foley catheter removal after 2 days. Patients experienced lower pain scores from the day of the operation to the following day. Postoperative follow-up revealed that 85.2% of patients achieved anatomic success, with 14.8% experiencing recurrent stage II cystocele. No recurrence of apical prolapse was observed. Complications were rare, with one case (3.7%) of asymptomatic mesh protrusion. (4) Conclusions: The modified vaginal mesh procedure using DynaMesh®-PR4 showed favorable outcomes with a short operation time, low recurrence rate, rare complications, and improved functional outcomes. This surgical option could be considered for anterior and apical pelvic organ prolapse in women.
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Affiliation(s)
- Chia-Ju Lin
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Chih-Ku Liu
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Hsiao-Yun Hsieh
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Ming-Jer Chen
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
| | - Ching-Pei Tsai
- Department of Obstetrics and Gynecology, Taichung Veterans General Hospital, Taichung 40705, Taiwan; (C.-J.L.); (M.-J.C.)
- Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung 40204, Taiwan
- Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taichung 40204, Taiwan
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Padoa A, Braga A, Fligelman T, Athanasiou S, Phillips C, Salvatore S, Serati M. European Urogynaecological Association Position Statement: Pelvic Organ Prolapse Surgery. UROGYNECOLOGY (PHILADELPHIA, PA.) 2023; 29:703-716. [PMID: 37490710 DOI: 10.1097/spv.0000000000001396] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/27/2023]
Affiliation(s)
| | | | | | - Stavros Athanasiou
- Urogynecology Unit, 1st Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Athens, Greece
| | - Christian Phillips
- Basingstoke and North Hampshire Hospital, Urogynaecology, Basingstoke, Hampshire, United Kingdom
| | - Stefano Salvatore
- Obstetrics and Gynecology Unit, Vita-Salute University and IRCCS San Raffaele Hospital, Scientific Institute, Milan, Italy
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Hong CX, Nandikanti L, Shrosbree B, Delancey JO, Chen L. Variations in structural support site failure patterns by prolapse size on stress 3D MRI. Int Urogynecol J 2023; 34:1923-1931. [PMID: 36802015 PMCID: PMC10577811 DOI: 10.1007/s00192-023-05482-9] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2022] [Accepted: 01/15/2023] [Indexed: 02/21/2023]
Abstract
INTRODUCTION AND HYPOTHESIS Our objective was to develop a standardized measurement system to evaluate structural support site failures among women with anterior vaginal wall-predominant prolapse according to increasing prolapse size using stress three-dimensional (3D) magnetic resonance imaging (MRI). METHODS Ninety-one women with anterior vaginal wall-predominant prolapse and uterus in situ who had undergone research stress 3D MRI were included for analysis. The vaginal wall length and width, apex and paravaginal locations, urogenital hiatus diameter, and prolapse size were measured at maximal Valsalva on MRI. Subject measurements were compared to established measurements in 30 normal controls without prolapse using a standardized z-score measurement system. A z-score greater than 1.28, or the 90th percentile in controls, was considered abnormal. The frequency and severity of structural support site failure was analyzed based on tertiles of prolapse size. RESULTS Substantial variability in support site failure pattern and severity was identified, even between women with the same stage and similar size prolapse. Overall, the most common failed support sites were straining hiatal diameter (91%) and paravaginal location (92%), followed by apical location (82%). Impairment severity z-score was highest for hiatal diameter (3.56) and lowest for vaginal width (1.40). An increase in impairment severity z-score was observed with increasing prolapse size among all support sites across all three prolapse size tertiles (p < 0.01 for all). CONCLUSIONS We identified substantial variation in support site failure patterns among women with different degrees of anterior vaginal wall prolapse using a novel standardized framework that quantifies the number, severity, and location of structural support site failures.
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Affiliation(s)
- Christopher X Hong
- Department of Obstetrics and Gynecology, University of Michigan, 1500 E. Medical Center Dr, Ann Arbor, MI, 48109, USA.
| | - Lahari Nandikanti
- University of Michigan Medical School, University of Michigan, Ann Arbor, MI, USA
| | - Beth Shrosbree
- University of Michigan Medical School, University of Michigan, Ann Arbor, MI, USA
| | - John O Delancey
- Department of Obstetrics and Gynecology, University of Michigan, 1500 E. Medical Center Dr, Ann Arbor, MI, 48109, USA
| | - Luyun Chen
- Department of Obstetrics and Gynecology, University of Michigan, 1500 E. Medical Center Dr, Ann Arbor, MI, 48109, USA
- Department of Biomedical Engineering, University of Michigan, Ann Arbor, MI, USA
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Okamura K, Hirabayashi T, Suzuki T, Koike M, Matsuura F, Suzuki A, Yoshino Y. Transvaginal mesh surgery for pelvic organ prolapse without blind maneuver. J Obstet Gynaecol Res 2023; 49:1036-1042. [PMID: 36597262 DOI: 10.1111/jog.15538] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/23/2022] [Accepted: 12/23/2022] [Indexed: 01/05/2023]
Abstract
AIM To present the techniques of transvaginal mesh surgery for pelvic organ prolapse without the blind maneuver and elucidate its safety and efficacy. METHODS This retrospective study included 45 women with a mean age of 77.9 years old. We investigated surgical outcomes including complications, anatomical recurrence rates, and changes in both subjective symptoms and quality of life. RESULTS The surgery required 111 ± 18 min and blood loss was 40 ± 24 g. Minor injuries of the bladder and rectum occurred in two and one patient, respectively. The urethral catheter was removed on postoperative day 1.1 and patients were discharged on postoperative day 4.4. No one experienced voiding dysfunction requiring catheterization. Wound infections occurred in two patients but they subsided with only antibiotics administered. Five patients had anatomical recurrence during a median follow-up of 17 months. Of these, two underwent reoperation and the remaining three were solely followed-up because there were no or few associated problems. Chronic pain, mesh erosion, and exposure were absent in all cases. Subjective symptoms and quality of life significantly improved after surgery at 12 months postoperatively. CONCLUSION It is considered that transvaginal mesh surgery without the blind maneuver is a safe and effective way to treat women with pelvic organ prolapse.
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Affiliation(s)
- Kikuo Okamura
- Department of Urology, National Hospital Organization Higashinagoya Hospital, Nagoya, Japan
| | | | - Tomohide Suzuki
- National Hospital Organization Nagoya Medical Center, Nagoya, Japan
| | - Mayumi Koike
- Department of Urology, National Hospital Organization Higashinagoya Hospital, Nagoya, Japan
| | | | - Akitaka Suzuki
- National Hospital Organization Nagoya Medical Center, Nagoya, Japan
| | - Yasushi Yoshino
- National Hospital Organization Nagoya Medical Center, Nagoya, Japan
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Transvaginal Mesh Compared With Native Tissue Repair for Pelvic Organ Prolapse. Obstet Gynecol 2022; 139:975-985. [PMID: 35675593 DOI: 10.1097/aog.0000000000004794] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/22/2021] [Accepted: 02/10/2022] [Indexed: 11/26/2022]
Abstract
OBJECTIVE To compare the safety and effectiveness of transvaginal mesh repair and native tissue repair, in response to a U.S. Food and Drug Administration (FDA) 522 study order to assess co-primary endpoints of superiority and noninferiority. METHODS This was a prospective, nonrandomized, parallel cohort, multi-center trial comparing transvaginal mesh with native tissue repair for the treatment of pelvic organ prolapse. The primary endpoints were composite treatment success at 36 months comprised of anatomical success (defined as pelvic organ prolapse quantification [POP-Q] point Ba≤0 and/or C≤0), subjective success (vaginal bulging per the PFDI-20 [Pelvic Floor Distress Inventory]), and retreatment measures, as well as rates of serious device-related or serious procedure-related adverse events. Secondary endpoints included a composite outcome similar to the primary composite outcome but with anatomical success defined as POP-Q point Ba<0 and/or C<0, quality-of-life measures, mesh exposure and mesh- and procedure-related complications. Propensity score stratification was applied. RESULTS Primary endpoint composite success at 36 months was 89.3% (201/225) for transvaginal mesh and 80.2% (389/485) for native tissue repair, demonstrating noninferiority at the preset margin of 12% (propensity score-adjusted treatment difference 6.5%, 90% CI -0.2% to 13.2%). Using the primary composite endpoint, transvaginal mesh was not superior to native tissue repair (P=.056). Using the secondary composite endpoint, superiority of transvaginal mesh over native tissue repair was noted (P=.009), with a propensity score-adjusted difference of 10.6% (90% CI 3.3-17.9%) in favor of transvaginal mesh. Subjective success for both the primary and secondary endpoint was 92.4% for transvaginal mesh, 92.8% for native tissue repair, a propensity score-adjusted difference of -4.3% (CI -12.3% to 3.8%). For the primary safety endpoint, 3.1% (7/225) of patients in the transvaginal mesh (TVM) group and 2.7% (13/485) of patients in the native tissue repair (NTR) group developed serious adverse events, demonstrating that transvaginal mesh was noninferior to native tissue repair (-0.4%, 90% CI -2.7% to 1.9%). Overall device-related and/or procedure-related adverse event rates were 35.1% (79/225) in the TVM group and 46.4% (225/485) in the NTR group (-15.7%, 95% CI -24.0% to -7.5%). CONCLUSION Transvaginal mesh repair for the treatment of anterior and/or apical vaginal prolapse was not superior to native tissue repair at 36 months. Subjective success, an important consideration from the patient-experience perspective, was high and not statistically different between groups. Transvaginal mesh repair was as safe as native tissue repair with respect to serious device-related and/or serious procedure-related adverse events. FUNDING SOURCE This study was sponsored by Boston Scientific and developed in collaboration with FDA personnel from the Office of Surveillance and Biometrics, Division of Epidemiology. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT01917968.
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Antosh DD, Dieter AA, Balk EM, Kanter G, Kim-Fine S, Meriwether KV, Mamik MM, Good MM, Singh R, Alas A, Foda MA, Rahn DD, Rogers RG. Sexual function after pelvic organ prolapse surgery: a systematic review comparing different approaches to pelvic floor repair. Am J Obstet Gynecol 2021; 225:475.e1-475.e19. [PMID: 34087227 DOI: 10.1016/j.ajog.2021.05.042] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2021] [Revised: 05/06/2021] [Accepted: 05/19/2021] [Indexed: 10/21/2022]
Abstract
OBJECTIVE Women consider preservation of sexual activity and improvement of sexual function as important goals after pelvic organ prolapse surgery. This systematic review aimed to compare sexual activity and function before and after prolapse surgery among specific approaches to pelvic organ prolapse surgery including native tissue repairs, transvaginal synthetic mesh, biologic grafts, and sacrocolpopexy. DATA SOURCES MEDLINE, Embase, and ClinicalTrials.gov databases were searched from inception to March 2021. STUDY ELIGIBILITY CRITERIA Prospective comparative cohort and randomized studies of pelvic organ prolapse surgeries were included that reported the following specific sexual function outcomes: baseline and postoperative sexual activity, dyspareunia, and validated sexual function questionnaire scores. Notably, the following 4 comparisons were made: transvaginal synthetic mesh vs native tissue repairs, sacrocolpopexy vs native tissue repairs, transvaginal synthetic mesh vs sacrocolpopexy, and biologic graft vs native tissue repairs. METHODS Studies were double screened for inclusion and extracted for population characteristics, sexual function outcomes, and methodological quality. Evidence profiles were generated for each surgery comparison by grading quality of evidence for each outcome across studies using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS Screening of 3651 abstracts was performed and identified 77 original studies. The overall quality of evidence was moderate to high. There were 26 studies comparing transvaginal synthetic mesh with native tissue repairs, 5 comparing sacrocolpopexy with native tissue repairs, 5 comparing transvaginal synthetic mesh with sacrocolpopexy, and 7 comparing biologic graft with native tissue repairs. For transvaginal synthetic mesh vs native tissue repairs, no statistical differences were found in baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, persistent dyspareunia, and de novo dyspareunia. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form change scores were not different between transvaginal synthetic mesh and native tissue repairs (net difference, -0.3; 95% confidence interval, -1.4 to 0.8). For sacrocolpopexy vs native tissue repairs, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, de novo dyspareunia, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form score differences were not different. For biologic graft vs native tissue repairs, baseline or postoperative sexual activity, baseline or postoperative total dyspareunia, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form changes were also not different. For transvaginal synthetic mesh vs sacrocolpopexy, there was no difference in sexual activity and sexual function score change. Based on 2 studies, postoperative total dyspareunia was more common in transvaginal synthetic mesh than sacrocolpopexy (27.5% vs 12.2%; odds ratio, 2.72; 95% confidence interval, 1.33-5.58). The prevalence of postoperative dyspareunia was lower than preoperative dyspareunia after all surgery types. CONCLUSION Sexual function comparisons are most robust between transvaginal synthetic mesh and native tissue repairs and show similar prevalence of sexual activity, de novo dyspareunia, and sexual function scores. Total dyspareunia is higher after transvaginal synthetic mesh than sacrocolpopexy. Although sexual function data are sparse in the other comparisons, no other differences in sexual activity, dyspareunia, and sexual function score change were found.
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Quality of Sexual Life after Native Tissue versus Polypropylene Mesh Augmented Pelvic Floor Reconstructive Surgery. J Clin Med 2021; 10:jcm10214807. [PMID: 34768326 PMCID: PMC8584420 DOI: 10.3390/jcm10214807] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2021] [Revised: 10/10/2021] [Accepted: 10/18/2021] [Indexed: 11/24/2022] Open
Abstract
There are still controversies around reconstructive surgeries used in POP treatment. The aim of this study was to compare the QoSL after VNTR vs. TVM surgery due to POP via the use of PISQ-12 and FSFI questionnaires. The study included a group of 121 sexually active patients qualified for reconstructive surgery due to symptomatic POP, and 50 control. The average results of PISQ-12 before and after surgery were compared using the t-test. The significance of the mean differences in demographic groups was measured using the t-test for independent samples and one-way ANOVA. The results in the demographic groups were compared using the Mann–Whitney U test and the Kruskal–Wallis test. Fifty-eight women had VNTR, while 63 had TVM. Results of PISQ-12 revealed significant improvement in the sexual life after reconstructive surgery (27.24 vs. 32.43; p < 0.001, t = 8.48) both after VNTR and TVM. There were no significant differences in the assessment of the QoSL according to PISQ-12 and FSFI results between both analyzed groups of patients (PISQ-12: VNTR vs. TVM; t-test p = 0.19 and FSFI: VNTR vs. TVM; Mann–Whitney U test p = 0.54). VNTR is the treatment of choice in the case of uncomplicated primary POP.
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12
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Scime NV, Ramage K, Brennand EA. Protocol for a prospective multisite cohort study investigating hysterectomy versus uterine preservation for pelvic organ prolapse surgery: the HUPPS study. BMJ Open 2021; 11:e053679. [PMID: 34607873 PMCID: PMC8491422 DOI: 10.1136/bmjopen-2021-053679] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023] Open
Abstract
INTRODUCTION Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a long-standing practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision making by patients and their healthcare providers. The objective of this study is to evaluate POP-specific health outcomes and service utilisation of women electing uterine suspension compared with those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year postsurgery. METHODS AND ANALYSIS This is a prospective cohort study planning to enrol 321 adult women with stage ≥2 POP from multiple sites in Alberta, Canada. Following standardised counselling from study surgeons, participants self-select either a hysterectomy based or uterine preservation surgical group. Data are being collected through participant questionnaires, medical records and administrative data linkage at four time points spanning from the presurgical consultation to 1-year postsurgery. The primary outcome is anatomic failure to correct POP, and secondary outcomes include changes in positioning of pelvic structures, retreatment, subjective report of bulge symptoms, pelvic floor distress and impact, sexual function and health service use. Data will be analysed using inverse probability weighting of propensity scores and generalised linear models. ETHICS AND DISSEMINATION This study is approved by the Conjoint Health Research Ethics Board at the University of Calgary (REB19-2134). Results will be disseminated via peer-reviewed publications, presentations at national and international conferences, and educational handouts for patients. TRIAL REGISTRATION NUMBER NCT04890951.
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Affiliation(s)
- Natalie V Scime
- Department of Community Health Sciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
| | - Kaylee Ramage
- Department of Community Health Sciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
| | - Erin A Brennand
- Department of Community Health Sciences, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
- Department of Obstetrics and Gynecology, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
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Eslami MJ, Zargham M, Gholipour F, Hajian M, Bakhtiari K, Hajebrahimi S, Eghbal M, Farajzadegan Z. Transvaginal repair of anterior vaginal wall prolapse with polyvinylidene fluoride (PVDF) mesh: an alternative for previously restricted materials? Int Urogynecol J 2021; 33:1989-1997. [PMID: 34586438 DOI: 10.1007/s00192-021-04977-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2021] [Accepted: 08/08/2021] [Indexed: 10/20/2022]
Abstract
INTRODUCTION AND HYPOTHESIS To study the mid-term safety and functional outcomes of transvaginal anterior vaginal wall prolapse repair using polyvinylidene fluoride (PVDF) mesh (DynaMesh®-PR4) by the double trans-obturator technique (TOT). METHODS Between 2015 and 2020, we prospectively included women with symptomatic high-stage anterior vaginal wall prolapse with or without uterine prolapse or stress urinary incontinence (SUI) in the study. The patients underwent transvaginal repair of the prolapse using PVDF mesh in two medical centers. We followed all patients for at least 12 months. We recorded the characteristics of vaginal and sexual symptoms, urinary incontinence, and prolapse stage pre- and postoperatively using International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF), and Pelvic Organ Prolapse Quantification (POP-Q) system, respectively. RESULTS One hundred eight women were included in the final analysis with a mean follow-up time of 34.5 ± 18.6 months. The anatomical success was achieved in 103 (95.4%) patients. There was a significant improvement in patients' vaginal symptoms, urinary incontinence, and quality of life scores postoperatively (p < 0.0001). Only six patients (5.5%) had mesh extrusion, five of whom were managed successfully. The total rates of complications and de novo urinary symptoms were 21.3% and 7.4%, respectively. Significant pain was reported in 17 cases (15.7%). CONCLUSION Our findings show that using PVDF mesh in the double TOT technique for anterior vaginal wall prolapse repair is a safe procedure with high anatomic and functional success rates and acceptable complication rates in mid-term follow-up.
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Affiliation(s)
| | - Mahtab Zargham
- Department of Urology, Isfahan University of Medical Sciences, Isfahan, Iran.
| | - Farshad Gholipour
- Isfahan Kidney Disease Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Mohammadreza Hajian
- Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Katayoun Bakhtiari
- Department of Obstetrics & Gynecology, Michigan Medicine, University of Michigan, Ann Arbor, USA
| | - Sakineh Hajebrahimi
- Research Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
| | - Melina Eghbal
- Department of Urology, Urmia University of Medical Sciences, Isfahan, Iran
| | - Ziba Farajzadegan
- Department of Community Medicine, Faculty of Medicine, Child Growth and Development Center, Isfahan University of Medical Sciences, Isfahan, Iran
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Levor O, Neuman M, Bornstein J. Outcomes of a fixed skeletonised mini mesh implant for pelvic organ prolapse repair with uterine preservation. J OBSTET GYNAECOL 2021; 42:490-493. [PMID: 34167432 DOI: 10.1080/01443615.2021.1916808] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Mesh repair of pelvic organ prolapse (POP) is complicated, causing erosions, postoperative pain and surgical failure. We hypothesised that reducing the mesh size and fixating it would result in significant cure rates and reduce complication rates. Here, we present the effectiveness of mini mesh implants in POP reconstruction. Sixty women who underwent repair of stage III and IV apical prolapse with cystocele or rectocele using skeletonised mesh implant Seratom PA MR MN® were evaluated. Anatomical outcomes were assessed using modified POP-quantification (POP-Q) staging and functional outcomes were self-reported by patients - one and three months post-operatively. Apical support with anterior and/or posterior colporrhaphy was performed, resulting in 96.6% success rate. Follow-up conducted one and three months post-operatively revealed significant improvement on the modified POP-Q (p < .001) and no complaints of dyspareunia. Para-vesicular fixation using a skeletonised mini mesh implant is feasible and effective in POP repair and has low surgical complication risk.Impact StatementWhat is already known on this subject? Mesh repair for pelvic organ prolapse (POP) is currently under scrutiny as it may result in erosions, postoperative pain, and surgical failure.What do the results of this study add? The use of an apical support with mini-mesh implants resulted in a 96.6% (58/60) success rate and excellent outcomes at 1- and 3-month follow-up.What are the implications of these findings for clinical practice and/or further research? Reconstruction using skeletonised and fixated mini-mesh implants may be safe and effective for POP treatment.
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Affiliation(s)
- Omri Levor
- Azrielli Faculty of Medicine in the Galilee, Bar Ilan University, Safed, Israel
| | - Menahem Neuman
- Assuta Medical Centers, Tel Aviv and Rishon LeZion, Nahariya, Israel
| | - Jacob Bornstein
- Azrielli Faculty of Medicine in the Galilee, Bar Ilan University, Safed, Israel.,Department of Obstetrics and Gynecology, Galilee Medical Center, Nahariya, Israel
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15
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Zhuo Y, Solak S, Harmanli O, Jones KA. Optimal treatment policies for pelvic organ prolapse in women. DECISION SCIENCES 2021. [DOI: 10.1111/deci.12521] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Affiliation(s)
- Yueran Zhuo
- Isenberg School of Management University of Massachusetts Amherst Amherst Massachusetts USA
| | - Senay Solak
- Isenberg School of Management University of Massachusetts Amherst Amherst Massachusetts USA
| | - Oz Harmanli
- Department of Obstetrics, Gynecology, and Reproductive Sciences Yale School of Medicine New Haven Connecticut USA
| | - Keisha A. Jones
- Department of Obstetrics and Gynecology University of Massachusetts Medical School Baystate Medical Center Springfield Massachusetts USA
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16
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Kim-Fine S, Antosh DD, Balk EM, Meriwether KV, Kanter G, Dieter AA, Mamik MM, Good M, Singh R, Alas A, Foda M, Rahn DD, Rogers RG. Relationship of postoperative vaginal anatomy and sexual function: a systematic review with meta-analysis. Int Urogynecol J 2021; 32:2125-2134. [PMID: 33988785 DOI: 10.1007/s00192-021-04829-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2021] [Accepted: 04/26/2021] [Indexed: 02/08/2023]
Abstract
INTRODUCTION AND HYPOTHESIS This was a planned secondary analysis of a systematic review that described sexual function outcomes following pelvic organ prolapse (POP) surgery. We aimed to describe the relationship of pre- and postoperative vaginal anatomic measures with sexual function outcomes. Data Sources included the Medline, Embase, and clinicaltrials.gov databases from inception to April 2018. METHODS The original systematic review included prospective, comparative studies that reported sexual function outcomes before and following POP surgery. Studies were extracted for population characteristics, sexual function outcomes, and vaginal anatomy, including total vaginal length (TVL) and genital hiatus. By meta-regression, we analyzed associations across studies between vaginal anatomic measurements and sexual function using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12) and dyspareunia outcomes. RESULTS We screened 3124 abstracts and identified 74 papers representing 67 original studies. Among these, 14 studies reported TVL and PISQ-12 outcomes. Nine studies reported TVL and dyspareunia outcomes, eight studies reported GH and PISQ-12 outcomes, and seven studies reported GH and dyspareunia outcomes. We found no associations between anatomic measures and PISQ-12 or dyspareunia, although, we found a statistically significant association found between preoperative TVL and change in PISQ-12. CONCLUSION Across studies, the evidence does not support an association between vaginal anatomy and either validated, condition-specific sexual function questionnaires or dyspareunia. However, no study has directly analyzed these associations in the setting of pelvic floor reconstructive surgery.
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Affiliation(s)
- Shunaha Kim-Fine
- Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, 4th Floor North Tower, 1403 29th Street NW, Calgary, Alberta, T2N 2T9, Canada.
| | - Danielle D Antosh
- Department of Obstetrics and Gynecology, Houston Methodist Hospital, Houston, TX, USA
| | - Ethan M Balk
- Center for Evidence Synthesis in Health, Brown University School of Public Health, Providence, RI, USA
| | - Kate V Meriwether
- Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM, USA
| | - Gregg Kanter
- Department of Obstetrics and Gynecology, Salinas Valley Memorial Healthcare System, Salinas, CA, USA
| | - Alexis A Dieter
- Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington, Hospital Center/Georgetown University School of Medicine, Washington, DC, USA
| | - Mamta M Mamik
- Department of Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, NY, USA
| | - Meadow Good
- Obstetrics and Gynecology, University of Florida, Jacksonville, FL, USA
| | - Ruchira Singh
- Obstetrics and Gynecology, University of Florida, Jacksonville, FL, USA
| | - Alexandriah Alas
- Department of Obstetrics and Gynecology, UT Health, San Antonio, TX, USA
| | - Mohamed Foda
- Department of Obstetrics and Gynecology, HCA/UCF Consortium, Gainesville, FL, USA
| | - David D Rahn
- Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA
| | - Rebecca G Rogers
- Department of Obstetrics and Gynecology, Albany Medical Center, Albany, NY, USA
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Ma Y, Zhang Y, Chen J, Li L, Liu X, Zhang L, Ma C, Wang Y, Tian W, Song X, Li Y, Zhu L. Mesenchymal stem cell-based bioengineered constructs enhance vaginal repair in ovariectomized rhesus monkeys. Biomaterials 2021; 275:120863. [PMID: 34139509 DOI: 10.1016/j.biomaterials.2021.120863] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2020] [Revised: 04/24/2021] [Accepted: 04/26/2021] [Indexed: 12/15/2022]
Abstract
Transvaginal meshes repair for treating pelvic organ prolapse (POP) was halted by the U. S. Food and Drug Administration (FDA) because they can lead to severe complications. Therefore, investigations of new therapeutic strategies are urgently needed. Cell-based regenerative therapy holds great promise for the repair and restoration of damaged tissue. Here, we generated a bioengineered graft by seeding human umbilical cord mesenchymal stem cells (HUMSCs) on bioscaffolds to reconstruct the damaged vagina. In the in vitro study, HUMSCs proliferated well and the density was appropriate after 5 days of culture. Besides, we demonstrated that the differentiation potential of HUMSCs was maintained with external growth factor stimulation. The complete transcriptomic profile of HUMSCs revealed that HUMSCs cultured on grafts produced significantly higher levels of proangiogenic cytokines than cells cultured in tissue culture plates (TCPs). Three months after implantation of the bioengineered grafts into ovariectomized (OVX) rhesus monkeys via sacrocolpopexy, extracellular matrix reorganization, large muscle bundle formation, angiogenesis and, mechanical properties of the vagina were enhanced. To our knowledge, this is the first demonstration of the utility of stem cell-based bioengineered grafts for repairing damaged vaginal tissue in rhesus monkeys. These results elucidate a new approach for vagina repair and provide new ideas for treating POP.
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Affiliation(s)
- Yidi Ma
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Ye Zhang
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Juan Chen
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Lei Li
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Xudong Liu
- Medical Science Research Center, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China
| | - Lin Zhang
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Congcong Ma
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Yuan Wang
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Weijie Tian
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Xiaochen Song
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
| | - Yaqian Li
- Medical Science Research Center, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China.
| | - Lan Zhu
- Department of Obstetrics and Gynaecology, National Clinical Research Center for Obstetric & Gynecologic Diseases, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.
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Naumann G, Hüsch T, Mörgeli C, Kolterer A, Tunn R. Mesh-augmented transvaginal repair of recurrent or complex anterior pelvic organ prolapse in accordance with the SCENIHR opinion. Int Urogynecol J 2021; 32:819-827. [PMID: 32970175 PMCID: PMC8009781 DOI: 10.1007/s00192-020-04525-9] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2020] [Accepted: 08/31/2020] [Indexed: 12/28/2022]
Abstract
INTRODUCTION AND HYPOTHESIS To evaluate the performance of mesh-augmented repair of anterior pelvic organ prolapse (POP) with or without apical vaginal wall involvement in women with recurrent or complex prolapse. METHODS This multicenter cohort study included women undergoing surgery with Calistar S (Promedon, Argentina) for anterior POP between 2016 and 2018. The SCENIHR opinion was considered for patient selection, surgeon's experience and choice of implant. Patients were prospectively invited to assess effectiveness and safety by anamnesis, validated questionnaires and pelvic examination. A composite endpoint defined by POP-Q ≤ 1, absence of a vaginal bulge symptom and repeated surgery for POP was used to define treatment success. Descriptive statistics were applied. McNemar or Wilcoxon signed rank tests were used as paired samples tests. The significance level was set at 5%. RESULTS A total of 107 non-fertile women with a mean age of 70.6 years were enrolled. Ninety-three (86.9%) women presented with recurrent prolapse. The mean follow-up time was 18.5 months. Treatment success was achieved in 76% of cases according the composite endpoint, with 98% reaching POP-Q ≤ 1 and a significant improvement in quality of life (p < 0.001). Mesh exposure occurred in six (5.6%) patients, although none required further surgery. Four (3.7%) patients reported dyspareunia, and a single (0.9%) patient displayed a prominence due to mesh folding. CONCLUSIONS Mesh-augmented repair of anterior POP is effective and safe in women with recurrent or complex prolapse. Hence, in a select patient population, the benefits of mesh-augmented POP repair still outweigh the risks.
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Affiliation(s)
- Gert Naumann
- Department of Gynecology and Obstetrics, Helios Hospital Erfurt, Nordhäuser Straße 74, 99089, Erfurt, Germany.
- Department of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.
| | - Tanja Hüsch
- Department of Urology and Pediatric Urology, University Medical Center of Johannes Gutenberg University, Mainz, Germany
- Promedon GmbH, Clinical Research, Kolbermoor, Germany
| | - Claudia Mörgeli
- Department of Urogynecology, St. Hedwig Hospital, Berlin, Germany
| | - Anna Kolterer
- Department of Gynecology and Obstetrics, Helios Hospital Erfurt, Nordhäuser Straße 74, 99089, Erfurt, Germany
| | - Ralf Tunn
- Department of Urogynecology, St. Hedwig Hospital, Berlin, Germany
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Anterior/Apical single incision mesh (Elevate™): Surgical experience, anatomical and functional results, and long-term complications. Eur J Obstet Gynecol Reprod Biol 2021; 260:166-170. [PMID: 33813235 DOI: 10.1016/j.ejogrb.2021.03.031] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2021] [Revised: 02/22/2021] [Accepted: 03/19/2021] [Indexed: 11/21/2022]
Abstract
OBJECTIVE Pelvic organ prolapse is a common condition among post-menopausal women, and surgery is often the standard treatment proposed. Native tissue vaginal surgery is burdened by a high rate of recurrence, and mesh vaginal surgery has become current practice. The purpose of this study was to evaluate the safety and the effectiveness of the vaginal kit Anterior/Apical single incision mesh Elevate™ for the correction of anterior and apical compartment prolapse. STUDY DESIGN Data of patients with symptomatic anterior vaginal prolapse stage ≥ II, receiving mesh repair with the Anterior/Apical Elevate single incision system between January 2010 and January 2015 were retrieved. Prolapse was classified according to the POP-Q system. The main outcome measure was anatomical success, while subjective and safety outcomes were secondary outcomes. RESULTS Anatomical success rate was 87.2 % for anterior compartment prolapse and 84.6 % for combined anterior and apical prolapse, while overall functional success rate was 96.2 % after a median follow-up of 33.6 months. The most frequent short-term complications were urinary bladder injury (3.0 %) and transient urinary retention (6.9 %). The most common long-term complications were de novo or persistent symptomatic stress urinary incontinence (10.8 %) and vaginal mesh extrusion (3.8 %). CONCLUSION Mesh vaginal surgery with Anterior/Apical single incision mesh Elevate™ is a well-tolerated procedure with a very high anatomical and functional success rate. Short and long-term complications rate seem to be acceptable, and in most of cases, solvable. Further studies are needed to confirm our promising data.
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21
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Fatton B, de Tayrac R, Letouzey V, Huberlant S. Pelvic organ prolapse and sexual function. Nat Rev Urol 2020; 17:373-390. [DOI: 10.1038/s41585-020-0334-8] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/05/2020] [Indexed: 11/09/2022]
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Ko KJ, Lee KS. Current surgical management of pelvic organ prolapse: Strategies for the improvement of surgical outcomes. Investig Clin Urol 2019; 60:413-424. [PMID: 31692921 PMCID: PMC6821990 DOI: 10.4111/icu.2019.60.6.413] [Citation(s) in RCA: 26] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/01/2019] [Accepted: 10/22/2019] [Indexed: 12/24/2022] Open
Abstract
There are a variety of surgical management strategies to help surgeons repair pelvic organ prolapse (POP). Surgical treatment for POP includes native tissue repair, augmentation with mesh, and minimally invasive surgeries. Currently, laparoscopic or robotic techniques for POP repair are increasing in popularity and continuing to evolve. The aim of this review is to present an up-to-date review of surgical techniques used for POP repair and to discuss ways to optimize surgical outcomes.
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Affiliation(s)
- Kwang Jin Ko
- Department of Urology, Hallym University Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea
| | - Kyu-Sung Lee
- Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Korea
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Powers SA, Burleson LK, Hannan JL. Managing female pelvic floor disorders: a medical device review and appraisal. Interface Focus 2019; 9:20190014. [PMID: 31263534 DOI: 10.1098/rsfs.2019.0014] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 05/07/2019] [Indexed: 02/07/2023] Open
Abstract
Pelvic floor disorders (PFDs) will affect most women during their lifetime. Sequelae such as pelvic organ prolapse, stress urinary incontinence, chronic pain and dyspareunia significantly impact overall quality of life. Interventions to manage or eliminate symptoms from PFDs aim to restore support of the pelvic floor. Pessaries have been used to mechanically counteract PFDs for thousands of years, but do not offer a cure. By contrast, surgically implanted grafts or mesh offer patients a more permanent resolution but have been in wide use within the pelvis for less than 30 years. In this perspective review, we provide an overview of the main theories underpinning PFD pathogenesis and the animal models used to investigate it. We highlight the clinical outcomes of mesh and grafts before exploring studies performed to elucidate tissue level effects and bioengineering considerations. Considering recent turmoil surrounding transvaginal mesh, the role of pessaries, an impermanent method, is examined as a means to address patients with PFDs.
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Affiliation(s)
- Shelby A Powers
- Department of Physiology, Brody School of Medicine, East Carolina University, 600 Moye Boulevard, Mailstop 634, Greenville, NC 27834-4354, USA
| | - Lindsey K Burleson
- Department of Physiology, Brody School of Medicine, East Carolina University, 600 Moye Boulevard, Mailstop 634, Greenville, NC 27834-4354, USA
| | - Johanna L Hannan
- Department of Physiology, Brody School of Medicine, East Carolina University, 600 Moye Boulevard, Mailstop 634, Greenville, NC 27834-4354, USA
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Pelvic organ prolapse repair with a trocarless mesh system: two-year results. Int Urogynecol J 2019; 31:1641-1646. [PMID: 31377840 DOI: 10.1007/s00192-019-04072-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2019] [Accepted: 07/24/2019] [Indexed: 10/26/2022]
Abstract
INTRODUCTION AND HYPOTHESIS Our aim was to investigate the efficacy of the EndoFast Reliant™ system, which is a novel trocarless mesh technology for the treatment of pelvic organ prolapse (POP). METHODS This was a retrospective cohort study including 31 female patients with POP who underwent vaginal repair. Total follow-up duration was 24 months. All patients were evaluated with a clinical history, POP-Q measures, pelvic ultrasound, body mass index (BMI), questionnaires on symptoms, and quality of life scoring system. RESULTS The mean age was 53 ± 9.7 years, and the mean BMI was 28.5 ± 3.9 kg/m2. The BMI of 20 patients was < 30 kg/m2. No intraoperative complications occurred. Prolapse was anatomically resolved in 87.1% of patients at 2-year follow-up. Four patients presented stage 1 non-symptomatic prolapse recurrence. De novo stress urinary incontinence developed in four (12.9%) cases and de novo urgency developed in two (6.4%) cases; all were diagnosed and treated easily with oral medication. One case of mesh exposure was found and treated conservatively. There was no migration of fasteners or mesh. Urinary retention, postoperative groin pain, and dyspareunia were not observed. CONCLUSIONS The EndoFast Reliant™ system was found successful with high success rates, short learning time and very low complication rates in our study. However, further prospective studies with higher patient numbers and longer follow-up durations are needed to reach definitive conclusions.
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Sohlberg EM, Dallas KB, Weeks BT, Elliott CS, Rogo-Gupta L. Reoperation rates for pelvic organ prolapse repairs with biologic and synthetic grafts in a large population-based cohort. Int Urogynecol J 2019; 31:291-301. [DOI: 10.1007/s00192-019-04035-3] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2019] [Accepted: 06/17/2019] [Indexed: 01/01/2023]
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Steures P, Milani AL, van Rumpt-van de Geest DA, Kluivers KB, Withagen MIJ. Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial. Int Urogynecol J 2019; 30:565-573. [PMID: 30159720 PMCID: PMC6450832 DOI: 10.1007/s00192-018-3757-5] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/22/2018] [Accepted: 07/31/2018] [Indexed: 01/01/2023]
Abstract
INTRODUCTION AND HYPOTHESIS The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP). MATERIALS AND METHODS Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events. RESULTS Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR: 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR: 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%). CONCLUSION At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.
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Affiliation(s)
- Pieternel Steures
- Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, The Netherlands.
- Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, Postbus 90153, 5200 ME, Den Bosch, The Netherlands.
| | - Alfredo L Milani
- Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, The Netherlands
| | | | - Kirsten B Kluivers
- Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.
| | - Mariëlla I J Withagen
- Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands
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Liao SC, Huang WC, Su TH, Lau HH. Changes in Female Sexual Function After Vaginal Mesh Repair Versus Native Tissue Repair for Pelvic Organ Prolapse: A Meta-Analysis of Randomized Controlled Trials. J Sex Med 2019; 16:633-639. [PMID: 30926518 DOI: 10.1016/j.jsxm.2019.02.016] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2018] [Revised: 02/15/2019] [Accepted: 02/21/2019] [Indexed: 10/27/2022]
Abstract
AIM To evaluate changes in female sexual function after transvaginal mesh (TVM) repair versus native tissue repair for pelvic organ prolapse. METHODS Eligible studies, published through November 2017, were retrieved through searches of ClinicalTrials.gov, MEDLINE, Embase, and Cochrane Review databases and associated bibliographies. We included randomized control trials of transvaginal prolapse surgery with either mesh repair or native tissue repair regarding the outcomes of sexual function, de novo and postoperative dyspareunia with a minimum of 3 months of follow-up. RESULTS Seventeen trials including 2,976 patients (1,488 with TVM repair and 1,488 with native tissue repair) were identified. There was no significant difference in postoperative dyspareunia after TVM repair versus native tissue repair (risk ratio [RR] = 1.07; 95% confidence interval [CI] = 0.76-1.50). Likewise, there was no significant difference in de novo dyspareunia after TVM repair versus native tissue repair (RR = 0.91; 95% CI = 0.52-1.61). There was also no significant difference in the short form Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score after TVM mesh repair versus native tissue repair (mean difference = 0.26; 95% CI = -1.34 to 1.85). CONCLUSION Sexual function and de novo and postoperative dyspareunia were similar between the patients who underwent TVM repair and those who underwent native tissue repair. Liao S-C, Huang W-C, Su T-H, et al. Changes in Female Sexual Function After Vaginal Mesh Repair Versus Native Tissue Repair for Pelvic Organ Prolapse: A Meta-Analysis of Randomized Controlled Trials. J Sex Med 2019;16:633-639.
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Affiliation(s)
- Sao-Chun Liao
- Department of Obstetrics and Gynecology, Mackay Memorial Hospital, New Taipei City, Taiwan; Department of Obstetrics and Gynecology, Hsinchu Mackay Memorial Hospital, Hsinchu City, Taiwan
| | - Wen-Chu Huang
- Department of Obstetrics and Gynecology, Mackay Memorial Hospital, New Taipei City, Taiwan; Mackay Medical College, New Taipei City, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei City, Taiwan
| | - Tsung-Hsien Su
- Department of Obstetrics and Gynecology, Mackay Memorial Hospital, New Taipei City, Taiwan; Department of Obstetrics and Gynecology, Hsinchu Mackay Memorial Hospital, Hsinchu City, Taiwan; Mackay Medical College, New Taipei City, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei City, Taiwan
| | - Hui-Hsuan Lau
- Department of Obstetrics and Gynecology, Mackay Memorial Hospital, New Taipei City, Taiwan; Mackay Medical College, New Taipei City, Taiwan; Mackay Junior College of Medicine, Nursing, and Management, Taipei City, Taiwan.
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Tennyson L, Rytel M, Palcsey S, Meyn L, Liang R, Moalli P. Characterization of the T-cell response to polypropylene mesh in women with complications. Am J Obstet Gynecol 2019; 220:187.e1-187.e8. [PMID: 30419195 DOI: 10.1016/j.ajog.2018.11.121] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2018] [Revised: 10/27/2018] [Accepted: 11/01/2018] [Indexed: 11/19/2022]
Abstract
BACKGROUND Polypropylene mesh is used widely for surgical treatment of pelvic organ prolapse and stress urinary incontinence. Although these surgeries demonstrate favorable functional and anatomic outcomes, their use has been limited by complications, the 2 most common being exposure and pain. Growing evidence suggests that T lymphocytes play a critical role in the regulation of the host response to biomaterials. OBJECTIVE The purpose of this study was to define and characterize the T-cell response and to correlate the response to collagen deposition in fibrotic capsules in mesh tissue complexes that are removed for the complications of pain vs exposure. STUDY DESIGN Patients who were scheduled to undergo a surgical excision of mesh for pain or exposure at Magee-Women's Hospital were offered enrollment. Forty-two mesh-vagina tissue complexes were removed for the primary complaint of exposure (n=24) vs pain (n=18). Twenty-one patients agreed to have an additional vaginal biopsy away from the site of mesh that served as control tissue. T cells were examined via immunofluorescent labeling for cell surface markers CD4+ (Th), CD8+ (cytotoxic) and foxp3 (T-regulatory cell). Frozen sections were stained with hematoxylin-eosin for gross morphologic condition and picrosirius red for collagen fiber analysis. Interrupted sodium-dodecyl sulfate gel electrophoresis was used to quantify the content of collagens type I and III, and the collagen III/I ratio. Transforming growth factor-β and connective tissue growth factor, which are implicated in the development of fibrosis, were measured via enzyme-linked immunosorbent assays. Data were analyzed with the Student's t tests, mixed effects linear regression, and Spearman's correlation coefficients. RESULTS Demographic data were not different between groups, except for body mass index, which was 31.7 kg/m2 for the exposure group and 28.2 kg/m2 for pain (P=.04). Tissue complexes demonstrated a marked, but highly localized, foreign body response. We consistently observed a teardrop-shaped fibroma that encapsulated mesh fibers in both pain and exposure groups, with the T cells localized within the tip of this configuration away from the mesh-tissue interface. All 3 T-cell populations were significantly increased relative to control: CD4+ T helper (P<.001), foxp3+ T regulatory (P<.001), and CD8+ cytotoxic T cell (P=.034) in the exposure group. In the pain group, only T-helper (P<.001) and T-regulatory cells (P<.001) were increased, with cytotoxic T cells (P=.520) not different from control. Picrosirius red staining showed a greater area of green (thin) fibers in the exposure group (P=.025) and red (thick) fibers in the pain group (P<.001). The ratio of area green/(yellow + orange + red) that represented thin vs thick fibers was significantly greater in the exposure group (P=.005). Analysis of collagen showed that collagen type I was increased by 35% in samples with mesh complications (exposure and pain) when compared with control samples (P=.043). Strong correlations between the profibrosis cytokine transforming growth factor-β and collagen type I and III were found in patients with pain (r≥0.833; P=.01) but not exposure (P>.7). CONCLUSION T cells appear to play a critical role in the long-term host response to mesh and may be a central pathway that leads to complications. The complexity of this response warrants further investigation and has the potential to broaden our understanding of mesh biology and clinical outcomes.
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Affiliation(s)
- Lauren Tennyson
- Department of Urology, University of Pittsburgh, Pittsburgh, PA
| | | | | | - Leslie Meyn
- Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA
| | - Rui Liang
- Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA; Magee Womens Research Institute, Pittsburgh, PA
| | - Pamela Moalli
- Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA; Magee Womens Research Institute, Pittsburgh, PA.
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Long-term follow-up of laparoscopic sacrocolpopexy: comparison of two different techniques used in urology and gynecology. Int Urogynecol J 2019; 30:623-632. [DOI: 10.1007/s00192-018-03858-w] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2018] [Accepted: 12/18/2018] [Indexed: 10/27/2022]
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Chang YW, Chuang FC, Wu LY, Yang TH, Kung FT, Huang KH. Evaluating the efficacy of the single-incision uphold system for pelvic organ prolapse repair. Taiwan J Obstet Gynecol 2019; 58:94-98. [DOI: 10.1016/j.tjog.2018.11.018] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/20/2017] [Indexed: 11/28/2022] Open
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Walter JE. A comparison of the use of mesh to native tissue in the management of vaginal vault prolapse. Best Pract Res Clin Obstet Gynaecol 2018; 54:73-88. [PMID: 30580956 DOI: 10.1016/j.bpobgyn.2018.11.006] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/08/2018] [Accepted: 11/12/2018] [Indexed: 01/04/2023]
Abstract
Vaginal vault prolapse afflicts millions of women and evokes significant psychosocial and pelvic floor dysfunction. The risk factors and modalities of conservative management are discussed in this study. There remains controversy in the optimal surgical management. This review serves to study the clinical conundrum of the decision-making process to utilize the mesh and the approach. In-depth evaluation of mesh-related postsurgical complications as compared to those associated with the native tissue is explored.
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Affiliation(s)
- Jens-Erik Walter
- McGill University, Fellowship in Female Pelvic Medicine & Reconstructive Surgery, D05.2541, 1001 Decarie Boulevard Montreal, QC, H4A 3J1, Canada.
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Pelvic Pain and Apical Prolapse Surgery: A Population-Based Retrospective Cohort Study. Female Pelvic Med Reconstr Surg 2018; 26:704-711. [PMID: 30489341 DOI: 10.1097/spv.0000000000000674] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVES The aims of this study were to evaluate the association of preoperative pelvic pain with operative characteristics and the association of patient and operative characteristics with postoperative pain. METHODS This is a retrospective cohort study utilizing Clinformatics DataMart, a large national commercial insurance database. We collected data for patients older than 18 years who underwent apical prolapse surgery between January 2005 and December 2014. We stratified data by preoperative (prior) pain and analyzed for associations of prior and postoperative pain. Logistic regression analysis was performed using SAS software. RESULTS A total of 14,440 patients met inclusion criteria and were analyzed. Patients with prior pain were more likely to have an abdominal (open or laparoscopic) approach, a concomitant hysterectomy, but less likely to have additional repairs or a mesh insertion (P < 0.001). Postoperative pain was less with a concomitant hysterectomy, whether they had prior pain (odds ratio [OR], 0.56; 95% confidence interval [CI], 0.41-0.77) or not (OR, 0.68; 95% CI, 0.56-0.82). Additional vaginal repairs were associated with more postoperative pain for those without prior pain (OR, 1.63; 95% CI, 1.3-2.04). Age older than 45 years was associated with less pain. Length of hospital stay of more than 2 days was associated with more pain. CONCLUSIONS Patients with prior pain were more likely to undergo an abdominal approach and have a concomitant hysterectomy. Postoperative pain was less with a concomitant hysterectomy, but more with additional vaginal repairs. There is a need to include pain as an outcome in future studies, particularly clinical trials.
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Alt CD, Benner L, Mokry T, Lenz F, Hallscheidt P, Sohn C, Kauczor HU, Brocker KA. Five-year outcome after pelvic floor reconstructive surgery: evaluation using dynamic magnetic resonance imaging compared to clinical examination and quality-of-life questionnaire. Acta Radiol 2018; 59:1264-1273. [PMID: 29409326 DOI: 10.1177/0284185118756459] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background Dynamic magnetic resonance imaging (dMRI) captures the entire pelvis during Valsalva maneuver and helps diagnosing pelvic floor changes after reconstructive surgery. Purpose To evaluate therapeutic outcome five years after reconstructive surgery using clinical examination, dMRI, and quality-of-life (QOL) questionnaire. Material and Methods Clinical examination, dMRI, and QOL questionnaire were conducted before surgery and in the follow-ups at 12 weeks, one year, and five years in women with pelvic organ prolapse (POP) stage ≥2. dMRI was performed at 1.5-T using a predefined protocol including sagittal T2-weighted (T2W) sequence at rest and sagittal T2W true-FISP sequence at maximum strain for metric POP measurements (reference points = bladder, cervix, pouch, rectum). Pelvic organ mobility (POM) was defined as the difference of the metric measurement at maximum strain and at rest. Results Twenty-six women with 104 MRI examinations were available for analysis. dMRI results mostly differ to clinical examination regarding the overall five-year outcome and the posterior compartment in particular. dMRI diagnosed substantially more patients with recurrent or de novo POP in the posterior compartment (n = 17) compared to clinical examination (n = 4). POM after five years aligns to preoperative status except for the bladder. POM reflects best the QOL results regarding defecation disorders. Conclusion A tendency for recurrent and de novo POP was seen in all diagnostic modalities applied. dMRI objectively visualizes the interaction of the pelvic organs and the pelvic floor after reconstructive surgery and POM correlated best with the women's personal impression on pelvic floor complaints.
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Affiliation(s)
- Céline D Alt
- Department of Diagnostic and Interventional Radiology, University of Heidelberg, Medical School, Heidelberg, Germany
- Department of Diagnostic and Interventional Radiology, University Duesseldorf, Medical Faculty, Duesseldorf, Germany
| | - Laura Benner
- Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany
| | - Theresa Mokry
- Department of Diagnostic and Interventional Radiology, University of Heidelberg, Medical School, Heidelberg, Germany
| | - Florian Lenz
- Department of Obstetrics and Gynecology, St. Marienkrankenhaus Ludwigshafen, Academic Teaching Hospital of the Faculty of Medicine Mannheim of the University of Heidelberg Medical Center, Ludwigshafen am Rhein, Germany
| | - Peter Hallscheidt
- Department of Diagnostic and Interventional Radiology, University of Heidelberg, Medical School, Heidelberg, Germany
- Radiological Department Darmstadt, Academic Teaching Practice of the University of Heidelberg Medical Center, Darmstadt, Germany
| | - Christof Sohn
- Department of Obstetrics and Gynecology, St. Marienkrankenhaus Ludwigshafen, Academic Teaching Hospital of the Faculty of Medicine Mannheim of the University of Heidelberg Medical Center, Ludwigshafen am Rhein, Germany
| | - Hans-Ulrich Kauczor
- Department of Diagnostic and Interventional Radiology, University of Heidelberg, Medical School, Heidelberg, Germany
| | - Kerstin A Brocker
- Department of Obstetrics and Gynecology, St. Marienkrankenhaus Ludwigshafen, Academic Teaching Hospital of the Faculty of Medicine Mannheim of the University of Heidelberg Medical Center, Ludwigshafen am Rhein, Germany
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Dawson ML, Cramer MS, Thompson DR, Vakili B. Microbiological Analysis of Urine Cultures in Women after Pelvic Reconstructive Surgery. Curr Urol 2018; 11:212-217. [PMID: 29997465 DOI: 10.1159/000447221] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2017] [Accepted: 10/11/2017] [Indexed: 11/19/2022] Open
Abstract
Background/Aims The rate of urinary tract infection (UTI) after pelvic reconstructive surgery ranges from 9 to 48% and the most common uropathogen is Escherichia coli (E. coli). The aim of the study is to identify the predominant uro-pathogen from urine cultures in women undergoing pelvic reconstructive surgery. Methods A retrospective review was conducted on women who underwent pelvic reconstructive surgery at a tertiary care center from July 2013 to June 2015. Data was collected from each postoperative visit to evaluate urinary tract symptoms, culture results and treatment in the 3-month postoperative interval. Results There were 880 cases reviewed (mean age of 59.6 years) during the study period. The most common organism in positive cultures was E. coli after surgery. The total UTI rate was 11.3%. Patients discharged with a Foley catheter had a UTI rate of 65.6% (p = 0.003). Diabetes, neurologic disease, tobacco use, recurrent UTIs and breast or gynecologic cancers had no significant association with UTI after surgery. Conclusion The most common organism identified is E. coli. Almost 12% of patients will develop a UTI after pelvic reconstructive surgery. The results of this study can influence management of lower urinary tract symptoms in the postoperative period.
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Affiliation(s)
- Melissa L Dawson
- Female Pelvic Medicine and Reconstructive Surgery, Department of OB/GYN, Drexel University College of Medicine, Philadelphia, PA
| | - Meagan S Cramer
- Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE, USA
| | - Dana R Thompson
- Center for Women's, Infants, and Children's Health Research, Christiana Care Health System, Newark, DE, USA
| | - Babak Vakili
- Center for Urogynecology and Pelvic Surgery, Department of Obstetrics and Gynecology, Christiana Care Health System, Newark, DE, USA
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Halpern-Elenskaia K, Umek W, Bodner-Adler B, Hanzal E. Anterior colporrhaphy: a standard operation? Systematic review of the technical aspects of a common procedure in randomized controlled trials. Int Urogynecol J 2018; 29:781-788. [PMID: 29214325 PMCID: PMC5948274 DOI: 10.1007/s00192-017-3510-5] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2017] [Accepted: 08/29/2017] [Indexed: 01/24/2023]
Abstract
INTRODUCTION Anterior colporrhaphy (AC) is considered a standard procedure and is performed all over the world. However, not a single step of the procedure has ever been truly standardized and the rates of failure show a wide range in the literature from 0% up to 92%. The aim of this systematic review was to evaluate the differences in technique and procedure worldwide. METHODS We performed a systematic literature search up to March 2016 using the MeSH terms "(anterior AND (colporrhaph* or colporhaph* or repair* or cystocel*)" using Preferred Reporting Items for Sytematic Reviews and Meta-Analyses (PRISMA). Only randomized controlled trials (RCT) were included in the systematic review. A 14-point checklist was used to assess the quality of surgery undertaken in each RCT. RESULTS Forty RCTs from all over the world were included in the review. The indication for AC was urinary incontinence and/or pelvic organ prolapse. A detailed description of colporrhaphy was not provided even in the well-conducted RCTs. The review showed differences in each step of the procedure, in perioperative care, in anesthesia and in surgeon' experience. CONCLUSION Our results highlight the problems concerning AC with the great range in postoperative outcomes. There is diversity in the anatomical structures used in the repair, in perioperative care and in the procedure itself.
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Affiliation(s)
- Ksenia Halpern-Elenskaia
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria.
| | - Wolfgang Umek
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria
| | - Barbara Bodner-Adler
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria
| | - Engelbert Hanzal
- Division of General Gynecology and Gynecologic Oncology, Department of Obstetrics and Gynecology, Medical University Vienna, Waehringer Guertel 18, 1090, Vienna, Austria
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Fekete Z, Kőrösi S, Pajor L, Bajory Z, Németh G, Kozinszky Z. Does anchoring vaginal mesh increase the potential for correcting stress incontinence? BMC Urol 2018; 18:53. [PMID: 29855312 PMCID: PMC5984302 DOI: 10.1186/s12894-018-0363-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2017] [Accepted: 05/11/2018] [Indexed: 11/22/2022] Open
Abstract
Background This study aims to explore the feasibility of anchoring a four-arm transvaginal mesh (TVM) to the mid-urethra to correct an anterior compartment POP–Quantification stage II–III (Q II–III) and concomitant genuine SUI. Methods We analysed clinical data from 248 patients with stage II–III anterior prolapse and concomitant SUI who had undergone surgery at a tertiary referral centre in Hungary between January 2008 and June 2010. One hundred and twenty-four women treated with anterior colporrhaphy and 62 patients implanted with a conventional permanent TVM were selected as historical matched controls. Sixty-two patients received a modified permanent TVM, where the mesh was fixed to the mid-urethra with two stitches for the purpose of potentially correcting SUI. Surgical complications were classified using the Clavien–Dindo (CD) classification system. Results The anti-SUI efficacy was minimally higher in the mTVM group than in the original TVM group (p = 0.44, 96.8% vs 91.9%, respectively), while prosthesis surgery was more effective than anterior colporrhaphy in improving the anterior compartment POP–Q status (96.8, 90.3% vs 64.5%, respectively). Anchoring the mesh did not increase the extrusion rate (p = 0.11). The de novo urge symptoms were not more prevalent among those who had received additional periurethral stitches (p = 1.00, 11.3% vs 12.9%). The incidence of reoperation observed in the mTVM group was non-significantly lower than that in the TVM group (p = 0.15, 6.5% vs 16.1%); however, the difference did not reach the level of significance. The early postoperative complication profile was more favourable among the mTVM patients (classified as CD I: 8.1%; CD II: 1.6%; and CD IIIb: 1.6%) as compared to the TVM group (p = 0.013). Conclusions The new, modified mesh surgery represents an effective procedure for prolapse and concomitant SUI with a decreased risk of short- and long-term complications.
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Affiliation(s)
- Zoltán Fekete
- Department of Urology, University of Szeged, Hungary, Semmelweis u. 1, Szeged, H-6725, Hungary. .,Department of Obstetrics and Gynaecology, University of Szeged, Hungary, Semmelweis u. 1, Szeged, H-6725, Hungary.
| | - Szilvia Kőrösi
- Department of Obstetrics and Gynaecology, University of Szeged, Hungary, Semmelweis u. 1, Szeged, H-6725, Hungary
| | - László Pajor
- Department of Urology, University of Szeged, Hungary, Semmelweis u. 1, Szeged, H-6725, Hungary
| | - Zoltán Bajory
- Department of Urology, University of Szeged, Hungary, Semmelweis u. 1, Szeged, H-6725, Hungary
| | - Gábor Németh
- Department of Obstetrics and Gynaecology, University of Szeged, Hungary, Semmelweis u. 1, Szeged, H-6725, Hungary
| | - Zoltan Kozinszky
- Department of Obstetrics and Gynaecology, Blekinge Hospital, Karlskrona, Sweden
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The Role of the Surgeon on Outcomes of Vaginal Prolapse Surgery With Mesh. Female Pelvic Med Reconstr Surg 2018; 23:293-296. [PMID: 28134701 DOI: 10.1097/spv.0000000000000395] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
INTRODUCTION Adverse outcomes after surgery for pelvic organ prolapse (POP) with mesh are often attributed to the mesh material with little attention paid to the influence of surgeon factors. We used a national data set to determine whether surgeon case volume and specialty influenced vaginal prolapse surgery outcomes with mesh. MATERIALS AND METHODS Public Use File data on a 5% random national sample of female Medicare beneficiaries were obtained from the Centers for Medicare and Medicaid Services. Women with a diagnosis of POP who underwent surgery with mesh between 2007 and 2008 were identified by relevant International Classification of Diseases, 9th Revision, Clinical Modification and Current Procedural Terminology, 4th Edition procedure codes. Outcomes were compared by surgeon case volume and specialty. RESULTS From 2007 to 2008, 1657 surgeries for POP were performed with mesh. Low-, intermediate-, and high-volume surgeons performed 881 (53%), 408 (25%), and 368 (22%) of the cases with mesh, respectively. The cumulative reoperation rates for low-, intermediate-, and high-volume providers were 6%, 2%, and 3%, respectively. The difference in reoperation rates between low and intermediate and low- and high-volume surgeons was statistically significant (P = 0.007 and 0.003, respectively). There was no significant difference in reoperation rates between gynecologists and urologists when vaginal mesh was implanted for POP surgery. CONCLUSIONS Low-volume surgeons performed most of the vaginal prolapse repairs with mesh and had significantly higher reoperation rates. Surgeon experience must be a consideration when reporting mesh-related complications of POP surgery.
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Larouche M, Geoffrion R, Walter JE. No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2018; 39:1085-1097. [PMID: 29080723 DOI: 10.1016/j.jogc.2017.05.006] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Abstract
OBJECTIVE This guideline reviews the evidence related to the risks and benefits of using transvaginal mesh in pelvic organ prolapse repairs in order to update recommendations initially made in 2011. INTENDED USERS Gynaecologists, residents, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with pelvic organ prolapse. TARGET POPULATION Adult women with symptomatic pelvic organ prolapse considering surgery and those who have previously undergone transvaginal mesh procedures for the treatment of pelvic organ prolapse. OPTIONS The discussion relates to transvaginal mesh procedures compared with other surgical options for pelvic organ prolapse (mainly about vaginal native tissue repairs and minimally about other alternatives such as biological and absorbable vaginal mesh and abdominally placed surgical mesh). OUTCOMES The outcomes of interest are objective and subjective success rates and intraoperative and postoperative complications, such as adjacent organ injury (urinary, gastrointestinal), infection, hematoma/bleeding, vaginal mesh exposure, persistent pain, dyspareunia, de novo stress urinary incontinence, and reoperation. EVIDENCE PubMed, Medline, the Cochrane Database, and EMBASE were searched using the key words pelvic organ prolapse/surgery*, prolapse/surgery*, surgical mesh, surgical mesh*/adverse effects, transvaginal mesh, and pelvic organ prolapse. RESULTS were restricted to English or French language and human research. Articles obtained through this search strategy were included until the end of June 2016. Pertinent new studies were added up to September 2016. Grey literature was not searched. Clinical practice guidelines and guidelines of specialty societies were reviewed. Systematic reviews were included when available. Randomized controlled trials and observational studies were included when evidence for the outcome of interest or in the target population was not available from systematic reviews. New studies not yet included in systematic reviews were also included. Only publications with study groups larger than 20 individuals were selected because this criterion was used in the largest meta-analysis referenced in this guideline. A total of 1470 studies were obtained; after selecting only applicable studies and excluding duplicates, 68 manuscripts were reviewed and included. VALUES The content and recommendations were drafted and agreed upon by the principal authors and members of the Urogynaecology Committee. The Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation methodology framework. The Summary of Findings is available upon request. BENEFITS, HARMS, AND/OR COSTS It is expected that this guideline will benefit women with pelvic organ prolapse by ensuring that health care providers are aware of outcomes related to transvaginal mesh procedures and steps in the management of related complications. This should guide patient-informed consent before such procedures are undertaken. The benefits clearly outweigh the potential harms or costs of implementation of this guideline, although no direct harms or costs are identified. GUIDELINE UPDATE Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations. SUMMARY STATEMENTS RECOMMENDATIONS.
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Obinata D, Sugihara T, Yasunaga H, Mochida J, Yamaguchi K, Murata Y, Yoshizawa T, Matsui T, Matsui H, Sasabuchi Y, Fujimura T, Homma Y, Takahashi S. Tension-free vaginal mesh surgery versus laparoscopic sacrocolpopexy for pelvic organ prolapse: Analysis of perioperative outcomes using a Japanese national inpatient database. Int J Urol 2018; 25:655-659. [DOI: 10.1111/iju.13587] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2017] [Accepted: 03/12/2018] [Indexed: 11/30/2022]
Affiliation(s)
- Daisuke Obinata
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
| | - Toru Sugihara
- Department of Urology; Tokyo Metropolitan Tama Medical Center; Fuchu City Tokyo
| | - Hideo Yasunaga
- Department of Clinical Epidemiology and Health Economics; School of Public Health; The University of Tokyo; Bunkyo-ku Tokyo
| | - Junichi Mochida
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
| | - Kenya Yamaguchi
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
| | - Yasutaka Murata
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
| | - Tsuyoshi Yoshizawa
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
| | - Tsuyoshi Matsui
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
| | - Hiroki Matsui
- Department of Clinical Epidemiology and Health Economics; School of Public Health; The University of Tokyo; Bunkyo-ku Tokyo
| | - Yusuke Sasabuchi
- Data Science Center; Jichi Medical University; Shimotsuke City Tochigi
| | | | - Yukio Homma
- Department of Urology; Japanese Red Cross Medical Center; Shibuya-ku Tokyo Japan
| | - Satoru Takahashi
- Department of Urology; Nihon University School of Medicine; Itabashi-ku Tokyo
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Buca DIP, Liberati M, Falò E, Leombroni M, Di Giminiani M, Di Nicola M, Santarelli A, Frondaroli F, Fanfani F. Long-term outcome after surgical repair of pelvic organ prolapse with Elevate Prolapse Repair System. J OBSTET GYNAECOL 2018. [PMID: 29537324 DOI: 10.1080/01443615.2017.1419462] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/17/2022]
Abstract
Female pelvic organ prolapse (POP) is a common condition and the correction of prolapse remains a major challenge for the surgical community. A retrospective study of women with POP undergoing pelvic reconstructive surgery with the Elevate System followed-up for 48 months. A total of 138 women with POP were included in the study. We observed an objective cure rate of 94.9% for the anterior wall after 4 years' follow-up. The subjective cure rate was 97.1%. Improvement in the urinary symptoms was seen after the surgery: the number of asymptomatic patients increased from 14.5 to 77% after the 4 years of follow-up. We reported no cases of bleeding, haematoma, mesh infection and bowel injury, while we had four cases of bladder injury and one case of sepsis. The mesh extrusion rate was 7.3%, all cases interested the anterior compartment. Postoperative dyspareunia and pelvic pain were rare. In this cohort, the Elevate Prolapse Repair System was associated with excellent long-term results, for both anatomical corrections of prolapse, with a high objective and subjective cure rate and a functional urinary outcome. Impact statement What is already known on this subject? Female pelvic organ prolapse is a common condition and the correction of prolapse remains a major challenge for the surgical community. The optimal treatment of POP has still to be determined. What do the results of this study add? The findings from this study shows that the Elevate Prolapse Repair System had high anatomic results associated with a good durability, low morbidity and excellent subjective outcome. To the best of our knowledge, this is the first study that reports a follow-up up to 48 months. What are the implications of these findings for clinical practice and/or further research? The Elevate Prolapse Repair System was associated with excellent long terms results in terms of safety, durability and tolerability during the 4 years' follow-up. Despite the fact that the Elevate kit produced by AMS was withdrawn from the market and it is no longer available, we believe that it is helpful to have data about the outcomes of a transvaginal mesh implant.
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Affiliation(s)
- Danilo Italo Pio Buca
- a Department of Obstetrics and Gynaecology , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Marco Liberati
- a Department of Obstetrics and Gynaecology , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Eleonora Falò
- a Department of Obstetrics and Gynaecology , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Martina Leombroni
- a Department of Obstetrics and Gynaecology , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Maria Di Giminiani
- b School of Medicine and Health Science , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Marta Di Nicola
- c Laboratory of Biostatistics Department of Medical , Oral and Biotechnological Sciences G. d'Annunzio University , Chieti , Italy
| | - Alessandro Santarelli
- a Department of Obstetrics and Gynaecology , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Franco Frondaroli
- a Department of Obstetrics and Gynaecology , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
| | - Francesco Fanfani
- d Department of Medicine and Ageing Sciences , G. d'Annunzio University of Chieti-Pescara , Chieti , Italy
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Luo DY, Yang TX, Shen H. Long term Follow-up of Transvaginal Anatomical Implant of Mesh in Pelvic organ prolapse. Sci Rep 2018; 8:2829. [PMID: 29434209 PMCID: PMC5809369 DOI: 10.1038/s41598-018-21090-w] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2017] [Accepted: 01/29/2018] [Indexed: 02/05/2023] Open
Abstract
Transvaginal mesh (TVM) is a minimally invasive but effective treatment for pelvic organ prolapse (POP). However, mesh exposure is a common and problematic complication after TVM. This study assessed the safety and long-term outcomes of TVM. A retrospective review was performed on the medical records of 175 consecutive patients who underwent TVM with the anatomical implant technique for pelvic organ prolapse at our center from April 2007 to December 2012. All operations were performed using TVM with the anatomical implant technique. Intraoperative variables, postoperative complications, and TVM outcomes were assessed. In average of 8 years (ranging from 4 to 10 years), the objective cure ratio reached 99.4%; and the subjective success rate of the TVM operation was 91.4%. Only 2 cases (1.1%) were identified as having mesh exposure. The reoperation rate was 4.0% (95% CI, 1.1–6.9%). No patients abstained from sex due to the operation or postoperative discomfort. Our anatomical implant technique for correcting POP is feasible in TVM procedures, which lead to favourable subjective and objective outcomes with the lowest rates of mesh exposure (1.1%) in published data. Therefore, performing TVM operations with the appropriate technique could consider to be permitted.
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Affiliation(s)
- De-Yi Luo
- Department of Urology, West China Hospital, Sichuan University, Chengdu, China.,Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China
| | - Tong-Xin Yang
- Department of Urology, West China Hospital, Sichuan University, Chengdu, China.,Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.,Department of Urology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China
| | - Hong Shen
- Department of Urology, West China Hospital, Sichuan University, Chengdu, China. .,Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.
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Glazener C, Breeman S, Elders A, Hemming C, Cooper K, Freeman R, Smith A, Hagen S, Montgomery I, Kilonzo M, Boyers D, McDonald A, McPherson G, MacLennan G, Norrie J. Clinical effectiveness and cost-effectiveness of surgical options for the management of anterior and/or posterior vaginal wall prolapse: two randomised controlled trials within a comprehensive cohort study - results from the PROSPECT Study. Health Technol Assess 2018; 20:1-452. [PMID: 28052810 DOI: 10.3310/hta20950] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND The use of mesh in prolapse surgery is controversial, leading to a number of enquiries into its safety and efficacy. OBJECTIVE To compare synthetic non-absorbable mesh inlay, biological graft and mesh kit with a standard repair in terms of clinical effectiveness, adverse effects, quality of life (QoL), costs and cost-effectiveness. DESIGN Two randomised controlled trials within a comprehensive cohort (CC) study. Allocation was by a remote web-based randomisation system in a 1 :1 : 1 ratio (Primary trial) or 1 : 1 : 2 ratio (Secondary trial), and was minimised on age, type of prolapse repair planned, need for a concomitant continence procedure, need for a concomitant upper vaginal prolapse procedure and surgeon. Participants and outcome assessors were blinded to randomisation; participants were unblinded if they requested the information. Surgeons were not blinded to allocated procedure. SETTING Thirty-five UK hospitals. PARTICIPANTS Primary study: 2474 women in the analysis (including 1348 randomised) having primary anterior or posterior prolapse surgery. Secondary study: 398 in the analysis (including 154 randomised) having repeat anterior or posterior prolapse surgery. CC3: 215 women having either uterine or vault prolapse repair. INTERVENTIONS Anterior or posterior repair alone, or with mesh inlay, biological graft or mesh kit. MAIN OUTCOME MEASURES Prolapse symptoms [Pelvic Organ Prolapse Symptom Score (POP-SS)]; prolapse-specific QoL; cost-effectiveness [incremental cost per quality-adjusted life-year (QALY)]. RESULTS Primary trials: adjusting for baseline and minimisation covariates, mean POP-SS was similar for each comparison {standard 5.4 [standard deviation (SD) 5.5] vs. mesh 5.5 (SD 5.1), mean difference (MD) 0.00, 95% confidence interval (CI) -0.70 to 0.71; standard 5.5 (SD 5.6) vs. graft 5.6 (SD 5.6), MD -0.15, 95% CI -0.93 to 0.63}. Serious non-mesh adverse effects rates were similar between the groups in year 1 [standard 7.2% vs. mesh 7.8%, risk ratio (RR) 1.08, 95% CI 0.68 to 1.72; standard 6.3% vs. graft 9.8%, RR 1.57, 95% CI 0.95 to 2.59]. There were no statistically significant differences between groups in any other outcome measure. The cumulative mesh complication rates over 2 years were 2 of 430 (0.5%) for standard repair (trial 1), 46 of 435 (10.6%) for mesh inlay and 2 of 368 (0.5%) for biological graft. The CC findings were comparable. Incremental costs were £363 (95% CI -£32 to £758) and £565 (95% CI £180 to £950) for mesh and graft vs. standard, respectively. Incremental QALYs were 0.071 (95% CI -0.004 to 0.145) and 0.039 (95% CI -0.041 to 0.120) for mesh and graft vs. standard, respectively. A Markov decision model extrapolating trial results over 5 years showed standard repair had the highest probability of cost-effectiveness, but results were surrounded by considerable uncertainty. Secondary trials: there were no statistically significant differences between the randomised groups in any outcome measure, but the sample size was too small to be conclusive. The cumulative mesh complication rates over 2 years were 7 of 52 (13.5%) for mesh inlay and 4 of 46 (8.7%) for mesh kit, with no mesh exposures for standard repair. CONCLUSIONS In women who were having primary repairs, there was evidence of no benefit from the use of mesh inlay or biological graft compared with standard repair in terms of efficacy, QoL or adverse effects (other than mesh complications) in the short term. The Secondary trials were too small to provide conclusive results. LIMITATIONS Women in the Primary trials included some with a previous repair in another compartment. Follow-up is vital to identify any long-term potential benefits and serious adverse effects. FUTURE WORK Long-term follow-up to at least 6 years after surgery is ongoing to identify recurrence rates, need for further prolapse surgery, adverse effects and cost-effectiveness. TRIAI REGISTRATION Current Controlled Trials ISRCTN60695184. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 95. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Cathryn Glazener
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Suzanne Breeman
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Andrew Elders
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | | | | | | | | | - Suzanne Hagen
- Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK
| | | | - Mary Kilonzo
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Dwayne Boyers
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK.,Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Alison McDonald
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Gladys McPherson
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Graeme MacLennan
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - John Norrie
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
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43
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Outcomes and Characteristics of Patients Undergoing Surgical Management for Mesh Related Complications. Female Pelvic Med Reconstr Surg 2018; 24:32-38. [DOI: 10.1097/spv.0000000000000434] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
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Fekete Z, Surányi A, Rénes L, Németh G, Kozinszky Z. Efficacy of anchoring the four-arm transvaginal mesh to the mid-urethra vs original surgery as a surgical correction for stress urine incontinence in coexisting anterior vaginal prolapse grades II and III: study protocol for a randomized controlled trial. Trials 2017; 18:624. [PMID: 29282115 PMCID: PMC5746023 DOI: 10.1186/s13063-017-2314-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/16/2017] [Accepted: 10/31/2017] [Indexed: 11/26/2022] Open
Abstract
BACKGROUND The prevalence of obesity with aging is escalating alarmingly; and pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are now becoming a growing epidemic among the elderly. Synthetic transvaginal mesh has been employed with increasing popularity in the treatment of POP and is usually highly effective in controlling the principal symptoms of prolapse. However, studies have reported that mesh operations provide fairly unfavorable SUI cure rates. Therefore, additional anti-incontinence surgical strategies are increasingly being scrutinized to achieve better postoperative continence without any significant side-effects for patients with both POP and SUI. We hypothesize that the modification with the fixing of the mesh to the mid-urethra is superior to the original transvaginal mesh operation (TVM) with regard to anti-incontinence. METHODS One hundred and thirty patients diagnosed with POP-Q II-III and concomitant SUI requiring surgical treatment will be included in this prospective, randomized, double-blind, controlled clinical trial. Patients will be randomly allocated to receive either original TVM (TVM group, n = 65) or modified TVM surgery (mTVM group, n = 65). As the primary outcome parameter, we will evaluate the objective SUI and POP cure rates. Secondary endpoints include postoperative morbidity as assessed with the International Urogynaecological Association classification and subjective prolapse and incontinence cure rates reported by questionnaires. DISCUSSION Recognizing the importance of an additional surgical procedure for anti-incontinence management, we aim to investigate whether a stabilizing suturing of the mesh to the mid-urethra delivers superior SUI correction compared to the original prosthesis surgery. TRIAL REGISTRATION ClinicalTrials.gov, NCT02935803. Registered on 20 May 2016.
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Affiliation(s)
- Zoltán Fekete
- Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Szeged, Semmelweis u. 1., 6725, Szeged, Hungary.
| | - Andrea Surányi
- Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Szeged, Semmelweis u. 1., 6725, Szeged, Hungary
| | - Lórand Rénes
- Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Szeged, Semmelweis u. 1., 6725, Szeged, Hungary
| | - Gábor Németh
- Division of Urogynaecology, Department of Obstetrics and Gynaecology, University of Szeged, Semmelweis u. 1., 6725, Szeged, Hungary
| | - Zoltan Kozinszky
- Department of Obstetrics and Gynaecology, Blekinge Hospital, Karlskrona, Sweden
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Castellani D, Galica V, Saldutto P, Galatioto GP, Vicentini C. Efficacy and safety of Elevate® system on apical and anterior compartment prolapse repair with personal technique modification. Int Braz J Urol 2017; 43:1115-1121. [PMID: 28266815 PMCID: PMC5734075 DOI: 10.1590/s1677-5538.ibju.2016.0233] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/21/2016] [Accepted: 09/11/2016] [Indexed: 11/22/2022] Open
Abstract
AIM To evaluate the effectiveness and safety of Anterior Elevate® mesh kit system (AES) in woman with symptomatic stage 3 or 4 anterior and/or apical pelvic organ prolapse (POP). MATERIALS AND METHODS This retrospective, monocentric, single surgeon study enrolled between May 2010 and January 2013 fifty-six woman experiencing symptomatic anterior vaginal prolapse with or without apical descent (POP-Q stage 3 or 4). All women received a AES and 7 (12.5%) received a concomitant transvaginal hysterectomy. Primary endpoint was anatomic correction of prolapse; success was defined as POP-Q stage ≤ 1 or asymptomatic stage 2. Secondary endpoints were quality-of-life (QOL) results and patients' safety outcomes, which were assessed by 3 validated self-reporting questionnaires at baseline and annually: ICIQ-UI short form, ICIQ-VS and P-QOL. All patients completed 2-years and 28 women 3-years of follow-up. Surgical approach was modified in women with uterus, moving the two-propylene strips anteriorly around the cervix itself crossing one another, so the left will take place in the right side and the right on the opposite. This modification was made in order to better support the uterus. RESULTS Vaginal mesh exposure was present in 3 (5,3%) patients. Very good anatomical outcomes were seen, with one (1,8%) failure at 6-months, 4 (7,1%) at 1-year, 6 at 2-years (10,7%). Statistically significant improvements were seen in the ICIQ-VS and P-QOL questionnaires throughout follow-up. CONCLUSION Our data suggest that AES is a minimally-invasive transvaginal procedure to repair anterior and apical POP, with good evidence related to mid-term safety and efficacy.
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Affiliation(s)
- Daniele Castellani
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, “Giuseppe Mazzini” Hospital, Teramo, Italy
| | - Vikiela Galica
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, “Giuseppe Mazzini” Hospital, Teramo, Italy
| | - Pietro Saldutto
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, “Giuseppe Mazzini” Hospital, Teramo, Italy
| | - Giuseppe Paradiso Galatioto
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, “Giuseppe Mazzini” Hospital, Teramo, Italy
| | - Carlo Vicentini
- Department of Life, Health & Environmental Sciences, University of L'Aquila, Urology Unit, “Giuseppe Mazzini” Hospital, Teramo, Italy
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Larouche M, Geoffrion R, Walter JE. N o 351-Interventions de treillis transvaginales visant le prolapsus des organes pelviens. JOURNAL OF OBSTETRICS AND GYNAECOLOGY CANADA 2017; 39:1098-1112. [DOI: 10.1016/j.jogc.2017.08.023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
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Montera R, Miranda A, Plotti F, Terranova C, Luvero D, Capriglione S, Scaletta G, Zullo MA, Buscarini M, Lopez S, Gatti A, Schirò T, De Cicco Nardone C, Angioli R. Anterior colporrhaphy plus inside-out tension-free vaginal tape for associated stress urinary incontinence and cystocele: 10-year follow up results. Neurourol Urodyn 2017; 37:1144-1151. [PMID: 29058820 DOI: 10.1002/nau.23439] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2017] [Accepted: 09/25/2017] [Indexed: 11/06/2022]
Abstract
AIMS We report the success rate and complications rate of combined ultralateral anterior Colporrhaphy plus Tension-free Vaginal Tape (TVT-O) in a long-term (10 year) follow-up prospective survey. METHODS Patients previously treated for associated stress urinary incontinence (SUI) and cystocele were subjected to annual follow-up for 10 year with a complete urogynecologic evaluation. Furthermore, an urodynamic assessment and a quality of life questionnaire (ICIQ-UI SF) were recorded at the 5th and 10th year of follow up. RESULTS Fifty patients treated between June 2004 and May 2006 were included in the analysis. Five patients did not return to 5-yr follow-up: two patients developed a median tape erosion and three patients withdraw. At 10-yr follow-up two more patients withdraw for a total of seven patients lost to follow-up. After 10 years patients objectively cured from cystocele were 41 (95%) while patients objectively cured from SUI were 39 (91%). At 10th year follow-up 38 patients (89%) result cured from both SUI and cystocele, 3 (7%) patients result cured only from prolapse, 1 (2%) patient only from SUI, and 1 (2%) patient result objectively failed for both SUI and cystocele. The ICIQ-UI SF scores at 10th year follow-up was 6.2 ± 3.7. The late complication rate at 10th year follow-up was 32% (OAB symptoms 20%; Mixed incontinence 2%; Bladder outlet obstruction 0%; Dyspareunia 6%; Chronic pelvic pain 0%; Vaginal tape erosion 4%; Detrusor hyperactivity 0%). CONCLUSIONS The combined procedures shown proved to be an effective and safe procedure to treat concomitant SUI and cystocele.
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Affiliation(s)
- Roberto Montera
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Andrea Miranda
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Francesco Plotti
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Corrado Terranova
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Daniela Luvero
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Stella Capriglione
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Giuseppe Scaletta
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Marzio A Zullo
- Department of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy
| | - Maurizio Buscarini
- Department of Urology, Campus Biomedico, University of Rome, Rome, Italy
| | - Salvatore Lopez
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Alessandra Gatti
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Teresa Schirò
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Carlo De Cicco Nardone
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
| | - Roberto Angioli
- Departments of Obstetrics and Gynecology, Campus Biomedico, University of Rome, Rome, Italy
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Abstract
PURPOSE OF REVIEW The purpose of this review is to summarize the treatment options for anterior compartment prolapse, describe the role that apical suspension plays in the correction of anterior vaginal wall prolapse, and assess the risks and benefits of biologic and synthetic graft use in anterior compartment repair. RECENT FINDINGS In 2016, The Cochrane Review published a review of 37 trials including 4023 participants finding that compared to native tissue repair, the use of synthetic mesh resulted in reduced symptomatic prolapse recurrence, anatomic recurrence, and repeat prolapse surgery. There was insufficient evidence regarding quality of life improvement or the use of biologic grafts. Of note the differences between native tissue and mesh kit repairs were not large. SUMMARY A strong consideration should be on the correction of apical prolapse when present; isolated anterior wall repairs should be pursued with caution. The surgeon may consider the use of augmenting materials in their repair of anterior vaginal wall prolapse, although the available evidence is not strongly supportive of their use given potential risks.
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Natalia S, Menahem N, Haim K, Dmitri P. The "Pelvic Harness": a skeletonized mesh implant for safe pelvic floor reconstruction. Int Braz J Urol 2017; 42:507-13. [PMID: 27286114 PMCID: PMC4920568 DOI: 10.1590/s1677-5538.ibju.2015.0177] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/28/2015] [Accepted: 05/06/2015] [Indexed: 11/22/2022] Open
Abstract
OBJECTIVES To evaluate the feasibility, safety and surgical results of skeletonized mesh implants to form a pelvic harness for pelvic floor reconstruction surgery. STUDY DESIGN Patients with advanced pelvic floor prolapse were enrolled to this study. Study model was a kit mesh, reduced to 75% of the original surface area by cutting out mesh material from the central mesh body. Patients were evaluated at the end of the 1st and 6th post-operative months and interviewed at the study conclusion. RESULTS Ninety-five women with advanced pelvic floor prolapse had this implant. Mean follow-up duration was 9 months (6-12 months). The POP-Q point's measurements showed marked and statistically significant improvements. Bladder over-activity symptoms, fecal incontinence, pelvic pain and constipation rates were all reduced as well. No adverse effects related to the dissection or mesh implantation were marked. The first and sixth post-operative month follow-up records as well as the study conclusion interview findings were satisfactory in terms of subjective and objective cure and adverse effects occurrence. CONCLUSION This study data proposes that skeletonizing meshes might be safely and successfully implanted for potentially improved pelvic floor reconstruction.
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Affiliation(s)
| | - Neuman Menahem
- Urogynecology Unit, Departaments of Obstetrics and Gynecology, Galilee Hospital, Nahariya.,Bar-Ilan University, Faculty of Medicine, Safed, Israel
| | - Krissi Haim
- Helen Schneider Hospital for Women, Rabin Medical Center, Petach Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Pushkar Dmitri
- Department of Urology, Moscow Medical Stomatological University, Russia
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Abstract
OBJECTIVE To update clinical practice guidelines on graft and mesh use in transvaginal pelvic organ prolapse repair based on systematic review. DATA SOURCES Eligible studies, published through April 2015, were retrieved through ClinicalTrials.gov, MEDLINE, and Cochrane databases and bibliography searches. METHODS OF STUDY SELECTION We included studies of transvaginal prolapse repair that compared graft or mesh use with either native tissue repair or use of a different graft or mesh with anatomic and symptomatic outcomes with a minimum of 12 months of follow-up. TABULATION, INTEGRATION, AND RESULTS Study data were extracted by one reviewer and confirmed by a second reviewer. Studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic absorbable, synthetic nonabsorbable), and outcome (anatomic, symptomatic, sexual function, mesh complications, and return to the operating room). We found 66 comparative studies reported in 70 articles, including 38 randomized trials; quality of the literature has improved over time, but some outcomes still show heterogeneity and limited power. In the anterior vaginal compartment, synthetic nonabsorbable mesh consistently showed improved anatomic and bulge symptom outcomes compared with native tissue repairs based on meta-analyses. Other subjective outcomes, including urinary incontinence or dyspareunia, generally did not differ. Biologic graft or synthetic absorbable mesh use did not provide an advantage in any compartment. Synthetic mesh use in the posterior or apical compartments did not improve success. Mesh erosion rates ranged from 1.4-19% at the anterior vaginal wall, but 3-36% when mesh was placed in multiple compartments. Operative mesh revision rates ranged from 3-8%. CONCLUSION Synthetic mesh augmentation of anterior wall prolapse repair improves anatomic outcomes and bulge symptoms compared with native tissue repair. Biologic grafts do not improve prolapse repair outcomes in any compartment. Mesh erosion occurred in up to 36% of patients, but reoperation rates were low.
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