Single incision slings: Are they ready for real life?

Table 2 Safety

Ref.	Design	Participants	Intervention	Comparison	Timing	Assessment	Pain rate/complications	P
Schweitzer et al[11]	RCT	156	Ajust: 100	TOT	Immediatepost-op and up to week 6	VAS	Median score week 1:	< 6 d: 0.01
			TOT: 56				Ajust: 0.2
							TOT: 1.0
							Median score week 2:	> 6 d: > 0.05
							Ajust: 0.0
							TOT: 0.5
Palomba et al[12]	RCT (Multi)	80	Ajust: 40	MiniArc	24 mo follow-up	VAS	Pain score Ajust:	All P > 0.05
			MiniArc: 40				5.3 ± 3.8
							Pain score MiniArc:
							5.0 ± 3.5
							Complications:
							Ajust: 17.5%
							MiniArc: 5%
							1 mesh erosion in Ajust group (no surgical revision)
Grigoriadis et al[14]	Prosp. matched controlled	171	Ajust: 85	TOT	Post-op and during follow-up	Patient’s impression	3.5% vs 5.8%	-
			TOT: 86
Natale et al[15]	Prosp. (Multi)	92	Ajust n = 92	-	Post-op and during follow-up	Patient’s impression	1 leg pain, 3 mesh extrusion (of which 1 mesh removal)	-
Naumann et al[16]	Prosp. (Multi)	51	Ajust	-	1 d after surgery and at during follow-up	VAS	1 patient day 1	-
Cornu et al[17]	Prosp.	95	Ajust		1-6 and 12 mo and yearly thereafter	Use of pain medication and surgeon’s and patient’s reports	1 vaginal bleeding managed surgically 8 h after surgery.	-
							At last follow-up 2 patients still complained of tight and vaginal pain respectively
Abdel-fattah et al[18]	Prosp. (Multi)	90	Ajust	-	Intra-op., after 30 min and 3 h pot-surgery or at the time of discharge	10 point Likert scale	1 case had to be converted in standard MUS (kit fault). Median pain rate at the time of the discharge was 0 and didn’t change during follow-up	-
Palma et al[19]	Prosp. (Multi)	124	Ophira	TOT	1-yr and 2 yr	Patient’s impression	1 patient severe intraoperative painà sedation. 2 mesh resection: 1.6%	P > 0.05
Djehdian et al[20]	RCT	120	TOT: 56		Day 1 and after 4-6 wk	VAS	0% vs 1.7%	P = 0.04
			Ophira: 64
Dias et al[21]	Prosp.	50	Altis	-	12 mo	Patient’s report	1 mesh erosion treated surgically (2%)
Kocjiancic et al[22]	Prosp. (Multi)	101	Altis	-	During 12 mo follow-up	Patient’s and surgeon’s reports	Non-pelvic pain: 9 (8%)
							3 serious adverse events (1 bleeding, 2 mesh extrusion requiring surgery)
Lee et al[25]	RCT	206	MiniArc: 103	Monarc	24 h after surgery and 12 mo follow-up	Patient’s and surgeon’s reports	Women requiring analgesia: 0.5 vs 2 tablets) and groin pain	P = 0.02
			Monarc: 103				9.7% vs 33%	P < 0.01
							1 mesh erosion in the MiniArc group at 1 yr follow-up
Schellart et al[26]	RCT	173	MiniArc: 86	Monarc	3 d and 4 wk	VAS	2 vs 3	P = 0.90
			Monarc: 87			Use of pain medications	8% vs 3%	P = 0.37
Basu et al[27]	RCT	71	MiniArc: 38	Advantage	During follow-up	Patient’s response on late adverse events	No late adverse events	-
			Advantage: 33
Oliveira et al[23,30]	Prosp.	71	MiniArc	-	First 24 h	VAS	1.0 ± 1.4	-
							(one patient had pain for 6 mo)
Deole et al[29]	Prosp.	59	MiniArc	-	Intra and post-op	Surgeon’s and patient’s reports and Wong-Baker score	No major intraoperative complications	-
							Wong-Baker score: 2 ± 1.5
Presthus et al[24]	Prosp.	31	MiniArc	-	Intra and post-op	Surgeon’s and patient reports and Wong baker faces	No major intraoperative complications	-
							Pain rate 9.6%
Kennelly et al[31]	Prosp. (Multi)	142	MiniArc	-	At discharge and at 7 d post-op	Surgeon’s and patient’s reports and Wong-Baker score	No major complications	-
							Median pain score 0

RCT: Randomized controlled trial; TOT: Trans obturator tape; Prosp.: Prospective; Multi: Multicentric.