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Van Isacker M, Van der Aa F. Impact of Single-Incision Sling Placement on Female Sexual Function in Women with Stress Urinary Incontinence. Int Urogynecol J 2025:10.1007/s00192-025-06058-5. [PMID: 39912922 DOI: 10.1007/s00192-025-06058-5] [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: 11/07/2024] [Accepted: 12/23/2024] [Indexed: 02/07/2025]
Abstract
INTRODUCTION AND HYPOTHESIS Stress urinary incontinence (SUI) is a common condition among women of childbearing age, often requiring surgical intervention. The midurethral sling (MUS), including first-generation tension-free vaginal tapes (TVT) and second-generation transobturator tapes (TOT, TVT-O), has long been the standard treatment. However, both approaches have associated risks, prompting the development of single-incision slings (SIS) as a third option. SIS have proven their efficacy in SUI treatment, but the impact of these slings on female sexual function specifically remains underexplored. METHODS A literature search was conducted using PubMed using the keywords "stress urinary incontinence," "midurethral slings," "single-incision slings," "female sexual function," and "dyspareunia." RESULTS The reviewed studies demonstrated that SIS generally maintain or improve sexual function postoperatively, but with varying impact on specific aspects of sexual function. While coital urinary incontinence often improved or resolved, new or worsened dyspareunia was reported in a significant number of patients. CONCLUSION SIS placement for SUI generally preserves or enhances sexual function, though individual aspects, such as dyspareunia, may worsen for some patients. Given that an important goal of SUI treatment is to improve quality of life, it is crucial to identify preoperative factors that will identify patients at risk of developing dyspareunia after surgery or are more likely to experience an improvement in sexual function. Further research is needed to better understand these predictors and optimize surgical outcomes for women undergoing SUI treatment with SIS.
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Affiliation(s)
- Marie Van Isacker
- Department of Urology, University Hospitals Leuven, Louvain, Belgium
| | - Frank Van der Aa
- Department of Urology, University Hospitals Leuven, Louvain, Belgium.
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Mikos T, Theodoulidis I, Karalis T, Zafrakas M, Grimbizis GF. Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review. Int Urogynecol J 2024; 35:2255-2279. [PMID: 39425774 DOI: 10.1007/s00192-024-05934-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2024] [Accepted: 08/21/2024] [Indexed: 10/21/2024]
Abstract
INTRODUCTION AND HYPOTHESIS Various instruments are used to evaluate the severity of stress urinary incontinence (SUI) in clinical trials for SUI surgery. We conducted a scoping review with the primary aim of investigating the use of such instruments. METHODS A comprehensive search in PubMed/MEDLINE, Cochrane Library, ClinicalTrials.gov, and WHO ICTRP was carried out. Inclusion criteria were studies including patients undergoing surgical intervention for SUI with assessment of SUI severity performed pre- and post-operatively. Exclusion criteria were nonprospective studies, nonrandomized studies, studies not in the English language, and the absence of reporting the methods of SUI severity evaluation in the study. RESULTS In total, 8,886 articles were identified, yielding 100 papers for data extraction. The most frequent interventions were mid-urethral slings (85 studies), Burch colposuspension (10 studies), and the use of bulking agents (3 studies). The most frequently used instruments for objective evaluation of SUI were urodynamics (90 studies), nonvalidated cough stress test (83 studies), and 1-h pad test (28 studies). The most frequently used instruments for subjective evaluation were bladder diary (37 studies), Incontinence Impact Questionnaire-7 (26 studies), and Urinary Distress Inventory-6 (23 studies). There were three studies reporting results according to the severity of pre- and post-operative SUI. CONCLUSIONS There is significant heterogeneity regarding the instruments used to evaluate the severity of SUI in surgical trials for female incontinence. There is a paucity of data regarding results according to the pre-operative severity of SUI. Hence, commonly agreed standardized methods for the assessment of SUI severity are needed to improve comparability between clinical trials for SUI surgery.
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Affiliation(s)
- Themistoklis Mikos
- 1st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Periferiaki Odos Thessalonikis, Nea Efkarpia, 56403, Thessaloniki, Greece.
| | - Iakovos Theodoulidis
- 1st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Periferiaki Odos Thessalonikis, Nea Efkarpia, 56403, Thessaloniki, Greece
| | - Tilemachos Karalis
- 1st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Periferiaki Odos Thessalonikis, Nea Efkarpia, 56403, Thessaloniki, Greece
| | - Menelaos Zafrakas
- 1st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Periferiaki Odos Thessalonikis, Nea Efkarpia, 56403, Thessaloniki, Greece
| | - Grigoris F Grimbizis
- 1st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Periferiaki Odos Thessalonikis, Nea Efkarpia, 56403, Thessaloniki, Greece
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Nipa SI, Cooper D, Mostafa A, Hagen S, Abdel-Fattah M. Novel clinically meaningful scores for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires in women with stress incontinence. Int Urogynecol J 2023; 34:3033-3040. [PMID: 37819367 PMCID: PMC10756866 DOI: 10.1007/s00192-023-05657-4] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2023] [Accepted: 09/12/2023] [Indexed: 10/13/2023]
Abstract
AIM To establish, for the first time, the clinically important differences for the ICIQ-UI-SF and ICIQ-FLUTS questionnaires following surgical and conservative treatments for stress-predominant urinary incontinence in women. METHODS Data from the SIMS and OPAL randomised controlled trials were analysed using an anchor-based method. Clinically important difference (CID; score change indicating a successful outcome) and minimal important difference (MID; score change indicating the smallest noticeable difference) were estimated using the PGI-I scale as the anchor. RESULTS For ICIQ-UI-SF, following surgical management, CIDs were 5.0 (95%CI 4.3, 5.6) at 1 year and 4.9 points (95%CI 4.2, 5.5) at 3 years, while following conservative management, CIDs were 4.0 (95%CI 3.4, 4.5) at 1 year and 4.6 points (95%CI 4.0, 5.2) at 2 years. For ICIQ-FLUTS, the CID was 3.4 points (95%CI 2.9, 4.0) at 1 year for both surgical and conservative management. MIDs for ICIQ-UI-SF, after surgical treatment, were 4.7 (95% CI 3.2, 6.1) at 1 year and 1.6 points (95%CI -0.2, 3.0) at 3 years, and after conservative treatment they were 1.7 (95% CI 1.0, 2.5) at 1 year and 1.9 points (95%CI 1.1, 2.7) at 2 years. For ICIQ-FLUTS, MIDs were 1.8 (95% CI 0.6, 3.1) at 1 year and 3.2 points (95%CI 2.0, 4.4) at 2 years after surgical treatment, and 1.3 (95%CI 0.6, 1.9) at 1 year and 1.9 points (95%CI 1.1, 2.6) at 2 years after conservative treatment. CONCLUSION Our study is the first to establish the CID for the ICIQ-UI-SF and ICIQ-FLUTS that women would associate with a successful outcome 3-years post-surgery and 2-years post-conservative treatment of stress-predominant urinary incontinence. The MID was lower following conservative compared to surgical treatment.
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Affiliation(s)
- Shamima Islam Nipa
- Department of Rehabilitation Science, Bangladesh Health Professions Institute (BHPI), Savar, Bangladesh
| | - David Cooper
- Health Services Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK
| | - Alyaa Mostafa
- Aberdeen Centre for Women's Health Research, Institute of Applied Health Sciences School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK
| | - Suzanne Hagen
- Glasgow Caledonian University, Cowcaddens Rd., Glasgow, UK
| | - Mohamed Abdel-Fattah
- Aberdeen Centre for Women's Health Research, School Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.
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Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2023; 10:CD008709. [PMID: 37888839 PMCID: PMC10604512 DOI: 10.1002/14651858.cd008709.pub4] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/28/2023]
Abstract
BACKGROUND Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single-incision slings are a minimally-invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid-urethra. The use of polypropylene mesh in urogynaecology, including mid-urethral slings, is restricted in many countries. This is a review update (previous search date 2012). OBJECTIVES To assess the effects of single-incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022. SELECTION CRITERIA We included randomised or quasi-randomised controlled trials in women with stress (or stress-predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single-incision sling. DATA COLLECTION AND ANALYSIS We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence. MAIN RESULTS We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single-incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment. Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT-Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates. We identified two cost-effectiveness analyses and one cost-minimisation analysis. Single-incision sling versus autologous fascial sling One study (70 women) compared single-incision slings to autologous fascial slings. It is uncertain if single-incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient-reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison. Single-incision sling versus retropubic sling Ten studies compared single-incision slings to retropubic slings. There may be little to no difference between single-incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low-certainty evidence). It is uncertain whether single-incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally-invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low-certainty evidence). It is uncertain whether single-incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low-certainty evidence). The effect of single-incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low-certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient-reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency. Single-incision sling versus transobturator sling Fifty-one studies compared single-incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single-incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high-certainty evidence). Single-incision slings probably have a reduced risk of patient-reported pain at 24 months post-surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate-certainty evidence). The effect of single-incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate-certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single-incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high-certainty evidence). Single-incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate-certainty evidence). Women with single-incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low-certainty evidence). It is unclear whether single-incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low-certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias. AUTHORS' CONCLUSIONS Single-incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single-incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer-term outcomes. Therefore, longer-term data are needed to clarify the safety and long-term effectiveness of single-incision slings compared to other mid-urethral slings.
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Affiliation(s)
- Emily Carter
- The Warrell Unit, St Mary's Hospital, Manchester University NHS Foundation Trust, Manchester, UK
| | - Eugenie E Johnson
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Madeleine Still
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Aalya S Al-Assaf
- National Institute for Health Research (NIHR) Innovation Observatory, Newcastle University, Newcastle Upon Tyne, UK
| | - Andrew Bryant
- Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
| | - Patricia Aluko
- National Institute for Health Research (NIHR) Innovation Observatory, Newcastle University, Newcastle Upon Tyne, UK
| | - Stephen T Jeffery
- Division of Urology, University of Cape Town, Cape Town, South Africa
| | - Arjun Nambiar
- Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK
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Schiavi MC, Carletti V, Yacoub V, Cardella G, Luffarelli P, Valensise HCC, Palazzetti P, Spina V, Zullo MA. Evaluation of the efficacy and safety of single incision sling vs TVT-O in obese patients with stress urinary incontinence: Quality of life and sexual function analysis. Taiwan J Obstet Gynecol 2023; 62:89-93. [PMID: 36720557 DOI: 10.1016/j.tjog.2022.07.011] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/05/2022] [Indexed: 01/30/2023] Open
Abstract
OBJECTIVES The aim of the study is to demonstrate the best stress urinary incontinence (SUI) surgical technique for women with a Body mass index higher than 30. The results of Transvaginal Tension Free Vaginal Tape-Obturator and Mini-sling surgery were analyzed and compared through both clinical examination and standardized questionnaires at 36 months of follow-up. MATERIALS AND METHODS This is a retrospective multicenter study over 159 women with SUI who underwent surgery. Seventy-eight women underwent TVT-O and 81 Mini-sling technique. Intra and post-operative complications were recorded. Patients were monitored for 36 months by analyzing symptoms, voiding diary, quality of life and sexual activity through standardized questionnaires. RESULTS Complications had a low incidence in both groups and inter-group differences were superimposable. Only groin pain was statistically higher after TVT-O than after Mini-sling (12.8% vs1.2%, p = 0.03). At 36 months of follow-up, a statistically significant decrease in Positive stress test (%) and Q-Tip test (grade) was observed in both groups with no differences between them (p = 0.54 and p = 0.32 respectively). The mean number of daily voids was higher after TVT-O (p = 0.04) than after Altis (p = 0.22) with a significant difference in favor of the Altis group (p = 0.03). After 36 months, there were no significant differences between groups in terms of quality of life and sexual activity. PGI-I did not show any difference between groups (p = 0.21). CONCLUSION TVT-O and Minisling had the same efficacy and results in the surgical treatment of SUI in obese women. Both techniques relieved their symptoms and improved their quality of life without any significant difference except for a lower incidence of post- Mini-sling complications.
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Affiliation(s)
| | - Valerio Carletti
- Department of Obstetrics and Gynecology, "Tor Vergata" University, Rome, Italy.
| | - Veronica Yacoub
- Department of Obstetrics and Gynecology, "Tor Vergata" University, Rome, Italy
| | - Giorgia Cardella
- Department of Obstetrics and Gynecology, "Tor Vergata" University, Rome, Italy
| | - Paolo Luffarelli
- Department of Pelvic Floor Surgery and Proctology, "Campus Biomedico" University, Rome, Italy
| | - Herbert Carmelo Carlo Valensise
- Department of Obstetrics and Gynecology, "Tor Vergata" University, Rome, Italy; Department of Obstetrics and Gynecology, "Casilino" Hospital, Rome, Italy
| | | | - Vincenzo Spina
- UOC Maternal and Child Health Protection, ASL Rieti, Italy
| | - Marzio Angelo Zullo
- Department of Pelvic Floor Surgery and Proctology, "Campus Biomedico" University, Rome, Italy
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Abdel-Fattah M, Cooper D, Davidson T, Kilonzo M, Boyers D, Bhal K, McDonald A, Wardle J, N'Dow J, MacLennan G, Norrie J. Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT. Health Technol Assess 2022; 26:1-190. [PMID: 36520097 PMCID: PMC9761550 DOI: 10.3310/btsa6148] [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] [Indexed: 12/23/2022] Open
Abstract
BACKGROUND Stress urinary incontinence is the most common type of urinary incontinence in premenopausal women. Until recently, synthetic mid-urethral slings (mesh/tape) were the standard surgical treatment, if conservative management failed. Adjustable anchored single-incision mini-slings are newer, use less mesh and may reduce perioperative morbidity, but it is unclear how their success rates and safety compare with those of standard tension-free mid-urethral slings. OBJECTIVE The objective was to compare tension-free standard mid-urethral slings with adjustable anchored single-incision mini-slings among women with stress urinary incontinence requiring surgical intervention, in terms of patient-reported effectiveness, health-related quality of life, safety and cost-effectiveness. DESIGN This was a pragmatic non-inferiority randomised controlled trial. Allocation was by remote web-based randomisation (1 : 1 ratio). SETTING The trial was set in 21 UK hospitals. PARTICIPANTS Participants were women aged ≥ 18 years with predominant stress urinary incontinence, undergoing a mid-urethral sling procedure. INTERVENTIONS Single-incision mini-slings, compared with standard mid-urethral slings. MAIN OUTCOME MEASURES The primary outcome was patient-reported success rates on the Patient Global Impression of Improvement scale at 15 months post randomisation (≈ 1 year post surgery), with success defined as outcomes of 'very much improved' or 'much improved'. The primary economic outcome was incremental cost per quality-adjusted life-year gained. Secondary outcomes were adverse events, impact on other urinary symptoms, quality of life and sexual function. RESULTS A total of 600 participants were randomised. At 15 months post randomisation, adjustable anchored single-incision mini-slings were non-inferior to tension-free standard mid-urethral slings at the 10% margin for the primary outcome [single-incision mini-sling 79% (212/268) vs. standard mid-urethral sling 76% (189/250), risk difference 4.6, 95% confidence interval -2.7 to 11.8; p non-inferiority < 0.001]. Similarly, at 3 years' follow-up, patient-reported success rates in the single-incision mini-sling group were non-inferior to those of the standard mid-urethral sling group at the 10% margin [single-incision mini-sling 72% (177/246) vs. standard mid-urethral sling 67% (157/235), risk difference 5.7, 95% confidence interval -1.3 to 12.8; p non-inferiority < 0.001]. Tape/mesh exposure rates were higher for single-incision mini-sling participants, with 3.3% (9/276) [compared with 1.9% (5/261) in the standard mid-urethral sling group] reporting tape exposure over the 3 years of follow-up. The rate of groin/thigh pain was slightly higher in the single-incision mini-sling group at 15 months [single-incision mini-sling 15% (41/276) vs. standard mid-urethral sling 12% (31/261), risk difference 3.0%, 95% confidence interval -1.1% to 7.1%]; however, by 3 years, the rate of pain was slightly higher among the standard mid-urethral sling participants [single-incision mini-sling 14% (39/276) vs. standard mid-urethral sling 15% (39/261), risk difference -0.8, 95% confidence interval -4.1 to 2.5]. At the 3-year follow-up, quality of life and sexual function outcomes were similar in both groups: for the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life, the mean difference in scores was -1.1 (95% confidence interval -3.1 to 0.8; p = 0.24), and for the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised, it was 0 (95% confidence interval -0.1, 0.1; p = 0.92). However, more women in the single-incision mini-sling group reported dyspareunia [12% (17/145), compared with 4.8% (7/145) in the standard mid-urethral sling group, risk difference 7.0%, 95% confidence interval 1.9% to 12.1%]. The base-case economics results showed no difference in costs (-£6, 95% confidence interval -£228 to £208) or quality-adjusted life-years (0.005, 95% confidence interval -0.068 to 0.073) between the groups. There is a 56% probability that single-incision mini-slings will be considered cost-effective at the £20,000 willingness-to-pay threshold value for a quality-adjusted life-year. LIMITATIONS Follow-up data beyond 3 years post randomisation are not available to inform longer-term safety and cost-effectiveness. CONCLUSIONS Single-incision mini-slings were non-inferior to standard mid-urethral slings in patient-reported success rates at up to 3 years' follow-up. FUTURE WORK Success rates, adverse events, retreatment rates, symptoms, and quality-of-life scores at 10 years' follow-up will help inform long-term effectiveness. TRIAL REGISTRATION This trial was registered as ISRCTN93264234. FUNDING This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 47. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Mohamed Abdel-Fattah
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | - David Cooper
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Tracey Davidson
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
| | - Mary Kilonzo
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Dwayne Boyers
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | - Kiron Bhal
- Obstetrics and Gynaecology, University Hospital of Wales, Cardiff, UK
| | - Alison McDonald
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | | | - James N'Dow
- Academic Urology Unit, University of Aberdeen, Aberdeen, UK
| | - Graeme MacLennan
- Aberdeen Centre For Women's Health Research, University of Aberdeen, Aberdeen, UK
| | - John Norrie
- Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK
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Lin YH, Lee CK, Chang SD, Chien PC, Hsu YY, Tseng LH. Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure: A protocol for systematic review and meta-analysis. Medicine (Baltimore) 2021; 100:e26257. [PMID: 34128853 PMCID: PMC8213295 DOI: 10.1097/md.0000000000026257] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2020] [Accepted: 05/20/2021] [Indexed: 01/04/2023] Open
Abstract
BACKGROUND There are 3 different types of mid-urethral sling, retropubic, transobturator and single incision performed for women with stress urinary incontinence. Prior studies comparing these three surgeries merely focused on the successful rate or efficacy. But nevertheless, what is more clinically important dwells upon investigating postoperative complications as a safety improvement measure. METHODS A systematic review via PubMed, Ovid, and the Cochrane Database of Systematic Review and studies were applied based on the contents with clearly identified complications. Selected articles were reviewed in scrutiny by 2 individuals to ascertain whether they fulfilled the inclusion criteria: complications measures were clearly defined; data were extracted on study design, perioperative complications, postoperative lower urinary tract symptoms, postoperative pain, dyspareunia, and other specified late complications. RESULTS A total of 55 studies were included in the systemic review. Perioperative complications encompassed bladder perforation, vaginal injury, hemorrhage, hematoma, urinary tract infection. There were postoperative lower urinary tract symptoms including urine retention and de novo urgency. Furthermore, postoperative pain, tape erosion/ extrusion, further stress urinary incontinence surgery, and rarely, deep vein thrombosis and injury of inferior epigastric vessels were also reported. CONCLUSIONS Complications of mid-urethral sling are higher than previously thought and it is important to follow up on their long-term outcomes; future research should not neglect to address this issue as a means to improve patient safety.
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Affiliation(s)
- Yi-Hao Lin
- Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital
- School of Medicine, Chang Gung University, Taoyuan
| | - Cheng-Kai Lee
- Department of Obstetrics and Gynecology, Taoyuan General Hospital, Ministry of Health and Welfare, Tao-Yuan City, Taiwan
| | - Shuenn-Dyh Chang
- Division of Urogynecology, Department of Obstetrics and Gynecology, Linkou, Chang Gung Memorial Hospital
- School of Medicine, Chang Gung University, Taoyuan
| | - Pei-Chun Chien
- Department of Obstetrics and Gynecology, Taoyuan General Hospital, Ministry of Health and Welfare, Tao-Yuan City, Taiwan
| | - Yu-Ying Hsu
- Department of Obstetrics and Gynecology, Taoyuan General Hospital, Ministry of Health and Welfare, Tao-Yuan City, Taiwan
| | - Ling-Hong Tseng
- Department of Obstetrics and Gynecology, Taoyuan General Hospital, Ministry of Health and Welfare, Tao-Yuan City, Taiwan
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Keršič M, Keršič M, Kunič T, Garzon S, Laganà AS, Barbič M, Lukanović A, Lukanović D. Single-Incision Mini-Sling for the Treatment of Female Stress Urinary Incontinence: Is it Actually Inferior to Transobturator Vaginal Tape and Tension-Free Vaginal Tape? Gynecol Minim Invasive Ther 2020; 9:123-130. [PMID: 33101912 PMCID: PMC7545044 DOI: 10.4103/gmit.gmit_78_19] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2019] [Revised: 02/04/2020] [Accepted: 03/17/2020] [Indexed: 12/11/2022] Open
Abstract
Objectives: The aim of the study was to report the extended long-term results of the use of single-incision mini-sling (SIMS), tension-free vaginal tape (TVT), and transobturator tape (TOT) for the treatment of female stress urinary incontinence (SUI) at the Department of Gynecology and Obstetrics of the University Medical Center Ljubljana. Materials and Methods: Enrolled women were evaluated by Patient Global Impression of Severity (PGI-S), Patient Global Impression of Improvement (PGI-I), Sandvik severity scale, Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) Short Form and data about diagnosis, procedures, complications, reoperations, postoperative results, and satisfaction with procedure were recorded. Results: In analyzed group of patients (n = 357), 116 (32%) underwent SIMS procedure, 189 (53%) TOT, and 52 (15%) TVT. The SIMS, TOT, and TVT groups did not differ significantly from each other in PGI-S, PGI-I, Sandvik severity scale, UDI-6, IIQ-7, and ICIQ-UI Short Form or in postoperative complication rate. Repeat surgery was needed in 9.5% after SIMS, in 13.2% of TOT patients and in 23.1% of TVT patients (P = 0.194). Urinary retention occurred in 9.5% of the SIMS patients, in 9.5% of the TOT patients, and in 13.5% of the TVT patients (P = 0.682). Mesh erosion/inflammation occurred in 3.4% of the SIMS patients, in 6.3% of the TOT patients, and in 3.8% of the TVT patients (P = 0.485). Conclusion: The efficacy and safety of SIMS, TOT, and TVT in the surgical treatment of SUI are comparable. The choice of the technique should be based on the relative pros and cons of techniques and the surgeon's experience.
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Affiliation(s)
- Matej Keršič
- Department of Obstetrics and Gynecology, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Maruša Keršič
- Department of Obstetrics and Gynecology, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Tina Kunič
- Department of Obstetrics and Gynecology, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Simone Garzon
- Department of Obstetrics and Gynecology, "Filippo Del Ponte" Hospital, University of Insubria, Varese, Italy
| | - Antonio Simone Laganà
- Department of Obstetrics and Gynecology, "Filippo Del Ponte" Hospital, University of Insubria, Varese, Italy
| | - Matija Barbič
- Department of Obstetrics and Gynecology, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - Adolf Lukanović
- Department of Obstetrics and Gynecology, University Medical Center Ljubljana, Ljubljana, Slovenia
| | - David Lukanović
- Department of Obstetrics and Gynecology, University Medical Center Ljubljana, Ljubljana, Slovenia
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Yıldız G, Batur AF, Akand M, Kılıç Ö, Şahin MO. Comparison of Two Single-Incision Mini-Slings for the Treatment of Incontinence. Med Princ Pract 2020; 30:85-91. [PMID: 32911466 PMCID: PMC7923843 DOI: 10.1159/000511465] [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] [Received: 06/09/2020] [Accepted: 09/05/2020] [Indexed: 11/19/2022] Open
Abstract
INTRODUCTION This study aimed to compare the safety and efficacy of 2 single-incision mini-sling (SIMS) systems with different designs of anchoring mechanism. METHODS The records of patients who have been operated for the treatment of female stress urinary incontinence (SUI) with 2 different SIMS systems were retrospectively evaluated. Patient characteristics, physical examination results, and quality of life (QoL) questionnaires were used to evaluate the patients. Primary efficacy endpoints were the cure and failure rates. Secondary efficacy endpoints were complications and differences in QoL questionnaires. RESULTS Eighty-three patients from group 1 (Ophira SIMS system) and 77 patients from group 2 (Gallini SIMS system) were evaluated. There was no significant difference between the 2 groups regarding patient characteristics. The objective cure rates were found to be 83.1 and 79.2% in group 1 and group 2, respectively (p = 0.09). Mesh-related complications, such as anchor displacement, bladder erosion, vaginal erosion, and groin pain, were more common in group 1. No severe complications were observed. For both groups, a significant improvement in all scores of QoL questionnaires was observed after surgery; however, the differences between 2 groups were not significant. CONCLUSIONS The present study showed that the treatment of female SUI with 2 different SIMS systems had similar efficacy, complication rates, and scores in QoL questionnaires.
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Affiliation(s)
- Guner Yıldız
- Urology Clinic, Health Sciences University Dr. Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Izmir, Turkey
| | - Ali Furkan Batur
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey,
| | - Murat Akand
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey
| | - Özcan Kılıç
- Department of Urology, Selçuk University, School of Medicine, Konya, Turkey
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Yee Cheung F, Farag F, MacLennan S, Yuan Y, Nambiar A, Omar MI. Is There Outcome Reporting Heterogeneity in Trials That Aim to Assess the Effectiveness of Surgical Treatments for Stress Urinary Incontinence in Women? Eur Urol Focus 2020; 7:857-868. [PMID: 32331796 DOI: 10.1016/j.euf.2020.03.008] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2020] [Revised: 03/12/2020] [Accepted: 03/24/2020] [Indexed: 10/24/2022]
Abstract
CONTEXT Inconsistent reporting of effectiveness outcomes in surgical trials of stress urinary incontinence (SUI) has hindered direct comparisons of various surgical treatments for SUI. OBJECTIVE To systematically review the verbatim outcome names, outcome definitions, and tools used to measure the outcomes in surgical trials of SUI in women. EVIDENCE ACQUISITION Trials of women with SUI who have undergone surgical interventions were included. We conducted a systematic review (SR) on outcomes reported in randomized controlled trials of surgical management published in 2014-2019, covering the following databases: MEDLINE, EMBASE, CENTRAL, and CDSR. Verbatim outcome names extracted from the included studies were categorized and then grouped into domains using the Williamson-Clarke (W/C) outcome taxonomy. A matrix was also created to visualize and quantify the dimensions of outcome reporting heterogeneity in SUI trials. EVIDENCE SYNTHESIS A total of 844 verbatim outcome names were extracted, of which, 514 varied terms were reduced to 71 standardized outcome names. They were further categorized into 11 domains from the W/C taxonomy. There were 7.24 different terms on average to describe each outcome, and the four outcomes with the most heterogeneity evident in terms used to describe them were "urinary retention", "reoperation", "subjective cure rate" and "quality of life". Each of them had ≥20 different terms. Only 28% of the outcome definitions were reported and a variety of measuring tools was noted, particularly in subjective outcomes. High heterogeneity was found in the outcome names, outcome definitions, choice and number of measuring instruments of the outcomes, and choice and number of outcomes reported across studies. CONCLUSIONS This SR provides objective evidence of heterogeneity in outcome reporting in SUI surgical trials. Our categorization of outcomes highlights the difficulties in summarizing the current evidence base. A core outcome set, developed using the methods advocated by the Core Outcome Measures in Effectiveness Trials (COMET) and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiatives, is required. PATIENT SUMMARY In this research, we have highlighted the diversity in outcomes reporting in stress urinary incontinence (SUI) surgical trials and have categorized the outcomes. We support the development of a core outcome set for SUI, which will promote future clinical researchers to measure the same outcome in the same way in all trials. This will, in turn, help researchers summarize the evidence more effectively and aid decision making for patients and doctors.
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Affiliation(s)
| | - Fawzy Farag
- Department of Urology, Norfolk and Norwich University Hospital, Norwich, UK
| | | | - Yuhong Yuan
- Department of Medicine, McMaster University,Hamilton, Ontario,Canada
| | - Arjun Nambiar
- Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK
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11
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Karakeçi A, Eftal TC, Keleş A, Gölbaşı C, Onur R. Single-incision midurethral sling shows less pain and similar success rate in a short-term follow-up compared to the transobturator tape method in the treatment of stress urinary incontinence. Turk J Urol 2019; 46:63-68. [PMID: 31658016 DOI: 10.5152/tud.2019.19105] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/20/2019] [Accepted: 06/10/2019] [Indexed: 01/22/2023]
Abstract
OBJECTIVE To compare the efficacy, complications, quality of life, and patient satisfaction rates in women treated for stress urinary incontinence (SUI) using the adjustable anchored single-incision midurethral sling (SIMS) and standard midurethral sling (MUS) procedures. MATERIAL AND METHODS A total of 113 women between October 2012 and October 2016 underwent either the adjustable SIMS (n=54) or MUS (n=57) procedure. The postoperative pain profile was assessed using a 10-point visual analog scale at the fixed time-point quality of life and an additional postoperative 3rd week appointment. We asked our patients the following two questions to evaluate their satisfaction with surgery and their preference: "Would you have this kind of surgery again?" (Q1), and "Would you recommend this type of surgery to another patient with same symptoms?" (Q2). For the evaluation of patient complaints, the Incontinence Impact Questionnaire (IIQ-7) and Urinary Distress Inventory (UDI-6) were used before and after the procedure. RESULTS Women in the SIMS group had a significantly lower postoperative pain profile for up to 3 weeks (p<0.001). There was no significant difference in perioperative complications and postoperative continence rates between the groups. With regard to Q1 and Q2, a significant difference was found between the groups (p=0.003 and p=0.002, respectively). While the questionnaire scores of the IIQ-7 and UDI-6 were also significantly improved at postoperative evaluations (p<0.001), there was no significant difference between the two groups. CONCLUSION SIMS is associated with a significantly improved postoperative pain profile and earlier return to work when compared to MUS.
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Affiliation(s)
- Ahmet Karakeçi
- Department of Urology, Fırat University School of Medicine, Elazığ, Turkey
| | - Taner Cüneyt Eftal
- Department of Obstetric and Gynecology, Tepecik Training and Research Hospital, İzmir, Turkey
| | - Ahmet Keleş
- Department of Urology, Esenyurt State Hospital, İstanbul, Turkey
| | - Ceren Gölbaşı
- Department of Obstetric and Gynecology, Tepecik Training and Research Hospital, İzmir, Turkey
| | - Rahmi Onur
- Department of Urology, Marmara University Pendik Training and Research Hospital, İstanbul, Turkey
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12
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Alexandridis V, Rudnicki M, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial. Int Urogynecol J 2019; 30:1465-1473. [PMID: 31222572 PMCID: PMC6706362 DOI: 10.1007/s00192-019-04004-w] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2019] [Accepted: 05/28/2019] [Indexed: 12/22/2022]
Abstract
Introduction and hypothesis The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. Results In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. Conclusions Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
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Affiliation(s)
- Vasileios Alexandridis
- Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden. .,Faculty of Medicine, Lund University, Lund, Sweden. .,Department of Obstetrics and Gynecology, Skane University Hospital, Jan Waldenströms gata 47, 214 66, Malmö, Sweden.
| | - Martin Rudnicki
- Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.,Department of Clinical Research, University of Southern Denmark, Odense, Denmark
| | - Ulf Jakobsson
- Faculty of Medicine, Lund University, Lund, Sweden.,Center for Primary Healthcare Research, Clinical Research Center, Malmö, Sweden
| | - Pia Teleman
- Department of Obstetrics and Gynecology, Skane University Hospital, Lund, Sweden.,Faculty of Medicine, Lund University, Lund, Sweden
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13
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Engberts MK, Schweitzer KJ, van Eijndhoven HWF, Cromheecke GJ, Naber HR, Huub van der Vaart C. A prospective observational cohort study of the Ajust® single incision sling performed under conscious sedation with local infiltration. Neurourol Urodyn 2019; 38:1632-1639. [PMID: 31102559 DOI: 10.1002/nau.24027] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/05/2019] [Revised: 03/20/2019] [Accepted: 04/22/2019] [Indexed: 11/06/2022]
Abstract
AIMS To evaluate the adjustable single-incision sling (Ajust®) in the treatment of stress urinary incontinence (SUI), when placed under conscious sedation with local infiltration, using the cough test during surgery. METHODS In this multicenter observational study, 90 women who had moderate to severe SUI, were asked to have the Ajust® procedure performed under sedation with local infiltration with levobupivacain. This allowed for a perioperative cough test to adjust the sling to the urethra till continence was reached. The primary outcome of the study was subjective cure of stress incontinence at 1 year follow up. Secondary objectives were objective and subjective improvement, complications during and after the procedure, and postoperative pain scores. These results were compared with the results of a historical control group of 96 patients who received their Ajust® under general or regional (spinal) anesthesia. RESULTS At 6 weeks and 12 months, there were no statistical significant differences in the results for subjective cure (83.6% and 71.6% sedation group, 88.4% and 77.2% general/regional anesthesia group), objective cure (96% and 86.9% sedation group, 88.1% and 91.8% general/regional anesthesia group), de novo urgency (10.5% and 6.7% sedation group, 7.1% and 24.1% general/regional anesthesia group) and the patients global impression of improvement (96% and 89.2% sedation group, 91.4% and 84.4% general/regional anesthesia group). CONCLUSION The performance of a cough test during the placement of an adjustable single-incision sling for the treatment of SUI does not affect the functional outcome, and is therefore not necessary.
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Affiliation(s)
- Marian K Engberts
- Departments of Reproductive Medicine and Gynecology and Anesthesiology, Isala, Zwolle
| | | | | | | | - Harry R Naber
- Departments of Reproductive Medicine and Gynecology and Anesthesiology, Isala, Zwolle
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14
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Kim A, Kim MS, Park YJ, Choi WS, Park HK, Paick SH, Choo MS, Kim HG. Clinical outcome of single-incision slings, excluding TVT-Secur, vs standard slings in the surgical management of stress incontinence: an updated systematic review and meta-analysis. BJU Int 2018; 123:566-584. [DOI: 10.1111/bju.14447] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Affiliation(s)
- Aram Kim
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Min Seo Kim
- College of Medicine; Korea University; Seoul Korea
| | - Young-Jin Park
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Woo Suk Choi
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Hyoung Keun Park
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Sung Hyun Paick
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
| | - Myung-Soo Choo
- Department of Urology; Asan Medical Centre; Ulsan University College of Medicine; Seoul Korea
| | - Hyeong Gon Kim
- Department of Urology; Konkuk University Medical Center; Konkuk University School of Medicine; Seoul Korea
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15
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Song P, Wen Y, Huang C, Wang W, Yuan N, Lu Y, Wang Q, Zhang T, Wen J. The efficacy and safety comparison of surgical treatments for stress urinary incontinence: A network meta-analysis. Neurourol Urodyn 2018; 37:1199-1211. [PMID: 29331033 DOI: 10.1002/nau.23468] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2017] [Accepted: 11/14/2017] [Indexed: 02/05/2023]
Abstract
AIMS Stress urinary incontinence (SUI) is a common problem worldwide. Mainstream surgical procedures include tension-free vaginal tape (TVT), transobturator tape (TOT), tension-free vaginal tape-obturator (TVT-O), tension-free vaginal tape SECUR (TVT-S), and adjustable single-incision sling (Ajust). The aim of this study was to compare the efficacy and safety of these surgical procedures and assess which surgery is most optimal for SUI by adopting a network meta-analysis (NMA). METHODS Electronic databases including PubMed, Cochrance Library, and Embase database were researched systematically, until March 21, 2017. The randomized controlled trials (RCTs) that compared the efficacy and safety of TVT, TOT, TVT-O, TVT-S, and Ajust were identified. The studies were included in the analysis when met the predefined inclusion criteria. After demographic and outcome data extraction, a network meta-analysis was conducted with software R 3.3.2 and STATA 14.0. Objective cure rate, subjective cure rate, postoperative complication rate, bladder perforation, tape erosion, urinary retention, and postoperative pain were considered as outcomes, and the outcomes were displayed as odds ratios (ORs) and 95% credible intervals (CrI). The consistency of direct and indirect evidence was assessed by node splitting. The ranks based on probabilities of intervention for the different endpoints were performed. RESULTS Fourty-five RCTs with 7295 participants were analyzed. The NMA results revealed that, TVT, TOT, and Ajust had a higher objective cure rate than TVT-O and TVT-S (TVT-O: OR = 0.76, 95%CI [0.61, 0.94]; TVT-S: OR = 0.41, 95%CI [0.28, 0.60]). TVT, TOT, and TVT-O had a superior subjective cure rate than TVT-S and Ajust (Ajust: OR = 0.45, 95%CI [0.20, 0.91]; TVT-S: OR = 0.29, 95%CI [0.15, 0.56]). With TVT as the reference, TVT-S had a statistically lower postoperative complication rate (TVT-S: OR = 0.39, 95%CI [0.16, 0.89]). TVT-O, TVT-S, and TOT had a significantly lower bladder perforation rate (TOT: OR = 0.076, 95%CI [0.0060, 0.37]; TVT-O: OR = 4.1e-17, 95%CI [6.1e-48, 0.0032]; TVT-S: OR = 3.8e-17, 95%CI [1.8e-48, 0.0052]). There were no obvious differences between the five treatments for tape erosion. TVT-O exhibited a less postoperative retention (TVT-O: OR = 0.35, 95%CI [0.16, 0.74]). Probabilities of ranking results indicated that TOT was the treatment with best ranking in efficacy and a relatively high safety. CONCLUSIONS Our study recommend TOT as the optimal regimen for SUI with high efficacy and moderate safety when compared with TVT, TVT-O, TVT-S, and Ajust interventions. However, with the limitation of our study, additional high-quality studies are needed to further evaluate the outcomes.
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Affiliation(s)
- Pan Song
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Yibo Wen
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Chuiguo Huang
- Department of Urology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Wancong Wang
- Department of Digestion, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Naijun Yuan
- The College of Traditional Chinese Medicine of Jinan University, Institute of Integrated Traditional Chinese and Western Medicine of Jinan University, Guangzhou, Guangdong Province, China
| | - Yinliang Lu
- Department of Radiotherapy, China-Japan Union Hospital of Jilin University, Changchun, Jilin Province, China
| | - Qingwei Wang
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Tao Zhang
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
| | - Jianguo Wen
- Department of Urodynamic Centre and Urology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
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Rudnicki M, von Bothmer-Ostling K, Holstad A, Magnusson C, Majida M, Merkel C, Prien J, Jakobsson U, Teleman P. Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence. A randomized controlled trial. Acta Obstet Gynecol Scand 2017; 96:1347-1356. [DOI: 10.1111/aogs.13205] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2016] [Accepted: 07/28/2017] [Indexed: 12/13/2022]
Affiliation(s)
- Martin Rudnicki
- Department of Obstetrics and Gynecology; Odense University Hospital; Odense Denmark
| | | | - Anja Holstad
- Department of Obstetrics and Gynecology; Gjøvik Hospital; Gjøvik Norway
| | - Claes Magnusson
- Department of Obstetrics and Gynecology; Sahlgrenska University Hospital; Gothenburg Sweden
| | - Memona Majida
- Department of Obstetrics and Gynecology; Ahus University Hospital; Oslo Norway
| | - Constanze Merkel
- Department of Obstetrics and Gynecology; Regional Hospital of Northern Jutland; Frederikshavn Denmark
| | - Jens Prien
- Department of Obstetrics and Gynecology; Zealand Hospital; Nykøbing Falster Denmark
| | - Ulf Jakobsson
- Center for Primary Healthcare Research; Faculty of Medicine; University of Lund; Lund Sweden
| | - Pia Teleman
- Department of Obstetrics and Gynecology; Skåne University Hospital; Lund University; Lund Sweden
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17
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Abdel-Fattah M, MacLennan G, Kilonzo M, Assassa RP, McCormick K, Davidson T, McDonald A, N’Dow J, Wardle J, Norrie J. The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial. BMJ Open 2017; 7:e015111. [PMID: 28801396 PMCID: PMC5724064 DOI: 10.1136/bmjopen-2016-015111] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/08/2016] [Revised: 01/30/2017] [Accepted: 03/08/2017] [Indexed: 12/17/2022] Open
Abstract
INTRODUCTION Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. METHODS AND ANALYSIS A pragmatic, multicentre, non-inferiority randomised controlled trial. PRIMARY OUTCOME MEASURE The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. SECONDARY OUTCOME MEASURES The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. STATISTICAL ANALYSIS The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. ETHICS AND DISSEMINATION The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. TRIAL REGISTRATION NUMBER ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020.
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Affiliation(s)
| | - Graeme MacLennan
- Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK
| | - Mary Kilonzo
- Health Economics Research Unit, University of Aberdeen, Aberdeen, UK
| | | | - Kirsty McCormick
- Centre for Healthcare Randomised Trials (CHRT), University of Aberdeen, Aberdeen, UK
| | | | | | - James N’Dow
- Chair in Surgery (Clinical), Academic Urology Unit, University of Aberdeen, Aberdeen, UK
| | | | - John Norrie
- Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK
- Chair in Surgery (Clinical), Academic Urology Unit, University of Aberdeen, Aberdeen, UK
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18
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Chang J, Lee D. Midurethral slings in the mesh litigation era. Transl Androl Urol 2017; 6:S68-S75. [PMID: 28791224 PMCID: PMC5522799 DOI: 10.21037/tau.2017.04.06] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2016] [Accepted: 03/26/2017] [Indexed: 01/04/2023] Open
Abstract
Stress urinary incontinence (SUI) has always been a major health issue for women. With the progression of technology and surgical techniques, mid urethral slings (MUS) used in both transvaginal and transobturator routes have become the gold standard in the treatment of SUI. There is ample short to mid-term data confirming the efficacy and safety in using MUS in treating SUI in women. However, long-term data supporting the use of MUS in women to treat SUI is scarce. There has been much controversy surrounding the US Food and Drug Administrations' (FDA) public notification of potential complications surrounding the use of transvaginal mesh, which has been magnified and generalised by the media; but despite this there has still been substantial growth and uptake of MUS for treating SUI. In this review, we aim to explore some of the issues with MUS, the factors around litigation with mesh use, the impact of FDA's notification on the uptake of MUS and ultimately, the results and efficacy of MUS for the treatment of SUI.
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Affiliation(s)
- John Chang
- Department of Urology, St George Hospital, Kogarah, Australia
| | - Dominic Lee
- Department of Urology, St George Hospital, Kogarah, Australia
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Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling. Int Urogynecol J 2016; 28:1041-1047. [DOI: 10.1007/s00192-016-3221-3] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2016] [Accepted: 11/21/2016] [Indexed: 11/25/2022]
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Gaber ME, Borg T, Samour H, Nawara M, Reda A. Two new mini-slings compared with transobturator tension-free vaginal tape for treatment of stress urinary incontinence: A 1-year follow-up randomized controlled trial. J Obstet Gynaecol Res 2016; 42:1773-1781. [DOI: 10.1111/jog.13143] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2016] [Accepted: 07/18/2016] [Indexed: 12/01/2022]
Affiliation(s)
- Mohamed E. Gaber
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
- Obstetrics and Gynecology Department; Heart of England NHS hospital; Sutton Coldfield UK
| | - Tamer Borg
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
| | - Hazem Samour
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
| | - Mai Nawara
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
| | - Ahmed Reda
- Obstetrics and Gynecology Department, Faculty of Medicine; Ain Shams University; Cairo Egypt
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Carmel ME, Deng DY, Greenwell TJ, Zimmern PE. Definition of Success after Surgery for Female Stress Incontinence or Voiding Dysfunction: An Attempt at Standardization. Eur Urol Focus 2016; 2:231-237. [DOI: 10.1016/j.euf.2016.03.005] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/01/2016] [Revised: 02/24/2016] [Accepted: 03/14/2016] [Indexed: 11/24/2022]
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A new validated score for detecting patient-reported success on postoperative ICIQ-SF: a novel two-stage analysis from two large RCT cohorts. Int Urogynecol J 2016; 28:95-100. [PMID: 27379890 PMCID: PMC5203851 DOI: 10.1007/s00192-016-3070-0] [Citation(s) in RCA: 39] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2016] [Accepted: 06/06/2016] [Indexed: 12/19/2022]
Abstract
Introduction and hypothesis The Patient Global Impression of Improvement (PGI-I) and International Consultation of Incontinence Questionnaire – Short Form (ICIQ-SF) are validated instruments for the assessment of patient reported outcome measures (PROM) following treatment of stress urinary incontinence (SUI). However, there is a paucity of evidence as to what represents a successful postintervention ICIQ-SF score. To determine the correlation between the postoperative ICIQ-SF scores with the PGI-I outcomes, the latter was considered one of the standard PROM following surgical treatment for SUI. The aim of this study was to determine, and if appropriate validate, an ICIQ-SF cut-off score that can predict a successful PROM as determined by PGI-I. Methods Four large datasets yielding 674 ICIQ-SF score/PGI-I outcome data pairs were used in this study for (a) determining and (b) validating the cut-off ICIQ-SF score for a successful PGI-I outcome. Two long-term follow-up datasets were used representing follow-up periods of 3 and 8 years of a randomized controlled trial (RCT) performed between April 2005 and April 2007 in a tertiary urogynaecology centre in Scotland, UK. All patients had urodynamic SUI or mixed urinary incontinence (MUI, with predominant SUI) and were randomized to treatment with either an inside-out or an outside-in transobturator tape (TVT-O or TOT, respectively) as a sole procedure. The datasets yielded 432 ICIQ-SF score/PGI-I outcome data pairs. Successful outcome was defined as “very much improved/much improved” on the PGI-I scale. SPSS v. 22.0 (IBM Corp., Armonk, NY) was used for all statistical analyses. The correlations and cut-off scores generated were then validated on two independent datasets representing the 1-year and 4-year follow-up periods of the multicentre RCT in six units in the UK. The datasets yielded 242 ICIQ-SF score/PGI-I outcome data pairs. All patients had urodynamic SUI or MUI (with predominant SUI) and were randomized to either adjustable single incision minisling (SIMS) or TVT-O. Results Significant correlations at the 0.01 level (two-tailed) were clearly demonstrated between ICIQ-SF scores at follow up and PGI-I outcomes in terms of success/failure in both the generation and validation datasets. Higher ICIQ-SF scores correlated with a ‘poorer’ PGI-I score. Using ROC analysis, a postoperative ICIQ-SF score of 6 was validated as approximately 90 % sensitive and 85 % specific for success/failure with a high Cohen’s kappa coefficient of 0.83 (95 % CI 0.74 – 0.89). Conclusions This two-stage study provided a robust well-validated postoperative ICIQ-SF cut-off score (of 6/21) that is likely to be associated with a patient-reported successful outcome on the PGI-I following surgical treatment with a midurethral sling in women at different stages of follow-up over 1 – 8 years. Such a cut-off score could enable the comparison of results between various studies and serve as a valuable guide for surgeons to counsel patients before and/or after surgical treatment. Our study fills a research gap in providing a way to compare trial results when baseline ICIQ-SF scores are not available.
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Tutolo M, De Ridder D, Van der Aa F. Single incision slings: Are they ready for real life? World J Obstet Gynecol 2016; 5:197-209. [DOI: 10.5317/wjog.v5.i2.197] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2015] [Revised: 11/23/2015] [Accepted: 01/22/2016] [Indexed: 02/05/2023] Open
Abstract
AIM: To review of the efficacy and safety outcomes of different single incision slings (SIS) systems, also in comparison with traditional slings.
METHODS: A literature search was conducted in PubMed/MEDLINE database. The research was restricted to randomized and/or prospective trials and retrospective studies, published after 2006, with at least 20 patients with non-neurogenic stress urinary incontinence (SUI). The studies had to assess efficacy and/or safety of the SIS with a minimum follow-up of 12 mo. All the paper assessing the performance of tension free vaginal tape secur were excluded from this review. The final selection included 19 papers fulfilling the aforementioned criteria. Two authors independently reviewed the selected papers.
RESULTS: Four different SIS systems were analysed: Ajust®, Ophira®, Altis® and MiniArc®. The average objective cure rate was 88%. Overall no statistically significant differences were found between SIS and traditional mid-urethral slings (MUS) in terms of objective cure (all P > 0.005). Only one paper showed a statistically lower success rate in MiniArc®vs Advantage® slings (40% vs 90%) and higher rates of failure in the SIS group. Since there was a great variability in terms of tests performed, it was not possible to compare subjective cure between studies. The vast part of the studies showed no major complications after SIS surgery. We also observed very low reported pain rates in SIS patients. The RCTs on Ajust® and MiniArc®, showed better outcomes in terms of post-operative pain compared to MUS. None of the patients reported long- term pain complains.
CONCLUSION: SIS showed similar efficacy to that of traditional slings but lower short-term pain, complication and failure rates.
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Masata J, Svabik K, Zvara K, Hubka P, Toman A, Martan A. Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial. Int Urogynecol J 2016; 27:1497-505. [DOI: 10.1007/s00192-016-3012-x] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2015] [Accepted: 03/14/2016] [Indexed: 11/29/2022]
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Prospective randomized comparison of the transobturator mid-urethral sling with the single-incision sling among women with stress urinary incontinence: 1-year follow-up study. Int Urogynecol J 2015; 27:791-6. [DOI: 10.1007/s00192-015-2895-2] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2015] [Accepted: 11/15/2015] [Indexed: 11/27/2022]
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Blaivas JG, Purohit RS, Benedon MS, Mekel G, Stern M, Billah M, Olugbade K, Bendavid R, Iakovlev V. Safety considerations for synthetic sling surgery. Nat Rev Urol 2015; 12:481-509. [DOI: 10.1038/nrurol.2015.183] [Citation(s) in RCA: 62] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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Meta-analysis of female stress urinary incontinence treatments with adjustable single-incision mini-slings and transobturator tension-free vaginal tape surgeries. BMC Urol 2015; 15:64. [PMID: 26148987 PMCID: PMC4492097 DOI: 10.1186/s12894-015-0060-3] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/31/2015] [Accepted: 06/22/2015] [Indexed: 11/10/2022] Open
Abstract
Background The study on SIMS and SMUS as a whole by Alyaa Mostafa et al showed that after excluding the TVT-S sling, there is no significant difference in patient-reported cure rate and objective cure rate between these two methods. In this paper, we systematically evaluate the relevant data on SIMS-Ajust and TVT-O/TOT and further confirm their safety and effectiveness, providing reliable clinical evidence. Methods By searching the Medline, Embase, Scopus, and Web of Science databases and the Cochrane Database of Systematic Reviews combined with manual searches, all reports on randomized controlled trials (RCTs) of single-incision mini-sling (SIMS-Ajust) and transobturator tension-free vaginal tape (TVT-O/TOT) surgeries were collected. Using RevMan 5.2 statistical software, the patient-reported cure rate, objective cure rate, operative time, postoperative pain, lower urinary tract injuries, groin pain, postoperative voiding difficulties, de novo urgency and/or worsening of preexisting surgery, vaginal tape erosion, repeated continence surgery, and other related data on both surgical methods were evaluated. Results A total of 154 relevant research reports were retrieved, and five randomized controlled trials were included in this study, involving a total of 678 patients. The meta-analysis results show no significant difference in the patient-reported cure rate and objective cure rate between SIMS-Ajust and TVT-O/TOT [RR = 0.95, 95 % CI (0.87 to 1.04), P > 0.05; RR = 0.97, 95 % CI (0.90–1.05), P > 0.05]. With respect to operation time and groin pain, SIMS-Ajust outperforms TVT-O/TOT [MD = −1.61, 95 % CI (−2.48 to 0.74), P < 0.05; RR = 0.30, 95 % CI (0.11 to 0.85), P < 0.05]. In terms of postoperative pain, lower urinary tract injuries, postoperative voiding difficulties, de novo urgency and/or worsening of preexisting surgery, vaginal tape erosion, and repetition of continence surgery, there is no significant difference between SIMS-Ajust and TVT-O/TOT [RR = 0.50, 95 % CI(0.18–1.43), P > 0.05; RR = 2.82, 95 % CI(0.14–57.76), P > 0.05; RR = 0.64, 95 % CI(0.28–1.45), P > 0.05; RR = 1.06, 95 % CI(0.66–1.71), P > 0.05; RR = 1.04, 95 % CI(0.24–4.45), P > 0.05; RR = 1.64, 95 % CI(0.41–6.61), P > 0.05]. Conclusions SIMS-Ajust is safe and effective in the treatment of female stress urinary incontinence. Compared with TVT-O/TOT surgery, SIMS-Ajust surgery has the same high objective cure rate and patient-reported cure rate and low incidence of perioperative complications, in addition to its short operative time and low incidence of groin pain. Its long-term efficacy needs further observation.
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Fan Y, Huang Z, Yu D. Incontinence-specific quality of life measures used in trials of sling procedures for female stress urinary incontinence: a meta-analysis. Int Urol Nephrol 2015; 47:1277-95. [DOI: 10.1007/s11255-015-1020-2] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2015] [Accepted: 05/23/2015] [Indexed: 02/03/2023]
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Postoperative pain after adjustable single-incision or transobturator sling for incontinence: a randomized controlled trial. Obstet Gynecol 2015; 125:27-34. [PMID: 25560100 DOI: 10.1097/aog.0000000000000604] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/11/2023]
Abstract
OBJECTIVE To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence (SUI). METHODS This single-blinded randomized controlled trial involved 156 women with clinically proven SUI. Women were allocated to receive either an adjustable single-incision or a transobturator sling. The primary outcome was postoperative pain score on a visual analog scale. Secondary outcomes were objective and subjective cure rates at 12 months, symptom bother scores, quality of life, and complications. RESULTS The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group. Maximum difference in pain score was reported on the evening of the day of surgery; median pain score was 1.0 (interquartile range 2.0) in the adjustable sling group and 3.0 (interquartile range 4.5) in the transobturator sling group (Mann Whitney U test P<.001). There was no statistical difference in analgesic use. The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8% and 88.6% (P=.760), and the subjective cure rates were 77.2% and 72.9% (P=.577), respectively. No difference in the complication rate was found. CONCLUSION An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up. CLINICAL TRIAL REGISTRATION Netherlands Trial Register, http://www.trialregister.nl, NTR: 2558. LEVEL OF EVIDENCE I.
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Short-term outcomes of adjustable single-incision sling (Ajust™) procedure for stress urinary incontinence: a prospective single-center study. Eur J Obstet Gynecol Reprod Biol 2015; 186:59-62. [PMID: 25645605 DOI: 10.1016/j.ejogrb.2015.01.002] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2014] [Revised: 12/29/2014] [Accepted: 01/12/2015] [Indexed: 01/15/2023]
Abstract
OBJECTIVES Slings have become the most widely performed surgical procedure for stress urinary incontinence (SUI) in last two decades. As the third generation sling, the efficacy of the early single-incision mini-sling was controversial. The aim of this study was to determine whether the new adjustable single-incision sling (Ajust™) is safe and effective in management of female SUI at 6-18 months follow-up. STUDY DESIGN 69 patients with SUI according the inclusion and exclusion criteria were considered adjustable single-incision sling (Ajust™) from September 2012 to September 2013. 67 patients finished 6-18 months follow-up. The data about clinical parameter, operation, complication, Urogenital Distress Inventory-Short Form (UDI-6), Incontinence Impact Questionnaire-Short Form (IIQ-7) and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) in Chinese were collected in preoperative, 6-month and 12-month follow-up. RESULTS All patients underwent successful adjustable single-incision sling (Ajust(TM)) placement. The subjective cure rate and objective cure rate was 82.0%, 92.5% in 6-month follow-up and 82.3%, 91.2% in 12-month follow-up respectively. There were no significant perioperative complications such as bladder perforation, major bleeding requiring blood transfusion in the present study. Sling exposure was observed in two patients (3.2%). CONCLUSIONS Adjustable single-incision sling (Ajust(TM)) was a safe and effective option for treating female SUI and was associated with comparable subjective and objective success rates when compared to standard midurethral slings (TVT-O) at a 6-18 months follow-up.
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Natale F, Dati S, La Penna C, Rombolà P, Cappello S, Piccione E. Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up. Eur J Obstet Gynecol Reprod Biol 2014; 182:48-52. [PMID: 25233444 DOI: 10.1016/j.ejogrb.2014.08.011] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/16/2014] [Revised: 06/13/2014] [Accepted: 08/07/2014] [Indexed: 02/09/2023]
Abstract
OBJECTIVE The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (Ajust™ C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. STUDY DESIGN In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King's Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status). RESULTS 92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King's Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram.
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Affiliation(s)
- Franca Natale
- Department of Urogynecology-S. Carlo-IDI Hospital, Rome, Italy.
| | - Stefano Dati
- Unit of Urogynecology, "Casilino" General Hospital, Rome, Italy
| | - Chiara La Penna
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
| | - Pasquale Rombolà
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
| | - Stefania Cappello
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
| | - Emilio Piccione
- Section of Gynecology and Obstetrics, Department of Surgery, "Tor Vergata" University, Rome, Italy
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Dias J, Xambre L, Costa L, Costa P, Ferraz L. Short-term outcomes of Altis single-incision sling procedure for stress urinary incontinence: a prospective single-center study. Int Urogynecol J 2014; 25:1089-95. [PMID: 24599178 DOI: 10.1007/s00192-014-2355-4] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2013] [Accepted: 02/07/2014] [Indexed: 02/06/2023]
Abstract
INTRODUCTION AND HYPOTHESIS Data on Altis® (Coloplast), a new adjustable single-incision sling (SIS) procedure for the treatment of female stress urinary incontinence (SUI), are scarce. Our aim was to evaluate the efficacy and complication rates of this procedure. METHODS In this prospective observational study, a total of 52 women with SUI were implanted with an Altis sling in an ambulatory setting. Before and after intervention (3, 6, and 12 months), women completed the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). In addition, patients underwent a cough stress test at each evaluation and a post-voiding residual urine volume estimation at 3 months. The main outcomes measured were subjective cure (ICIQ-SF = 0), subjective improvement (ICIQ-SF >0 and < preoperative ICIQ-SF), and objective cure (negative cough stress test and no pad usage) rates. De novo overactive bladder (OAB) symptoms, changes in voiding habits and adverse events were also analyzed. RESULTS The subjective cure rate at 12 months was 84.0%, with an additional improvement rate of 8.0%. The objective cure rate was 90.2%. Later postoperative complications included 1 case of vaginal extrusion (requiring surgical removal of the eroded mesh segment), 3 cases of vaginal exposure of the adjustment thread (managed conservatively), de novo urgency in 3 patients, and mild dyspareunia in 2 patients. CONCLUSIONS The Altis sling is a safe and effective SIS procedure for the treatment of SUI with a short-term follow-up.
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Affiliation(s)
- Jorge Dias
- Urology Department, Centro Hospitalar Vila Nova de Gaia/Espinho, EPE, Rua Conceição Fernandes, 4434-502, Vila Nova de Gaia, Portugal,
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Debodinance P. [AJUST: prospective study about 60 patients]. Prog Urol 2014; 24:154-5. [PMID: 24560201 DOI: 10.1016/j.purol.2013.11.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2013] [Accepted: 11/05/2013] [Indexed: 11/16/2022]
Affiliation(s)
- P Debodinance
- Service de gynécologie-obstétrique, centre hospitalier de Dunkerque, avenue de la Polyclinique, 59760 Grande Synthe, France.
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