Single incision slings: Are they ready for real life?

Table 1 Efficacy

Ref.	Design	Participants	Intervention (n)	Comparison	Follow-up	Cure assessment	Cure rate	Assessment of improvement or success	Improv. rate	Success rate	P
Schweitzer et al[11]	RCT	156	Ajust: 100	TOT	12 mo	OC: CST	OC: 90.8% vs 88.6%		-	-	OC: 0.76
			TOT: 56			SC: UDI-6	SC: 77.2% vs 72.9%				SC: 0.57
Palomba et al[12]	RCT (Multi)	80	Ajust: 40	MiniArc	24 mo	OC: CST	OC: 47% vs 55%		-	-	P > 0.05
			MiniArc: 40			SC: % dry? Or improved?	SC: 52.5% vs 65%				P > 0.05
Mostafa et al[13]	RCT (Multi)	137	Ajust: 69	TOT	12 mo	OC: CST	OC: 81.2 vs 82.3%				P = 1
			TVT-O: 68			SC: PGI-I	SC: 85.5% vs 84%				P = 1
Grigoriadis et al[14]	Prosp matched controlled	171	Ajust: 85	TOT	22.3 mo (mean)	OC: CTS	OC: 84% vs 86%	-
			TOT: 86			SC: Patient impression	SC: 81.2% vs 82.6%
Natale et al[15]	Prosp. (Multi)	92	Ajust: 92	-	24 mo	OC: CST	OC: 83.7%		-	-	-
						SC: PGI-I	SC: 81.5%
Naumann et al[16]	Prosp. (Multi)	51	Ajust	-	25.2 ± 2.24 mo (mean)	OC: CTS	82.4%	Ingelmann-Sundberg scale	3.9%	86.3%	-
Cornu et al[17]	Prosp.	95	Ajust		21 ± 6 mo (mean)	OC: Pad usage	OC: 80%	-	-	80%	-
						SC: Subjective reports of leakage	SC: 83%
Abdel-fattah et al[18]	Prosp. (Multi)	90	Ajust	-	12 mo	-	-	PGI-I	86%	80%	-
Palma et al[19]	Prosp. (Multi)	124	Ophira		12 mo	OC: 1 h- PWT	OC: 85.3%	Leakage < 50%	6.30%
Djehdian et al[20]	RCT	120	Ophira: 64	TOT	12 mo	OC: CST/	OC: 68.1% vs 81.9% (ITT)	-	-	-	P = 0.43 and 0.54
			TOT: 56			20 min pad test	and 73% vs 89% (PP)
						SC: Patient satisfaction	SC: 81.1% vs 88.5% (ITT) and 87.5% vs 96.4% (PP)				P = 0.11 and 0.10
Dias et al[21]	Prosp.	50	Altis	-	12 mo	CST	OC: 90.2%	ICIQ-SF lower than pre-op or > 0	8%
						ICIQ-SF = 0	SC: 84%
Kocjiancic et al[22]	Prosp. (Multi)	101	Altis	-	12 mo	OC: PWT (< 50% pad weight compared to baseline)	OC: 90%	-	-	-	-
						and CST	OC: 90.1%
						SC: PGI-I	SC: 89.3%
Lee et al[25]	RCT	206	MiniArc: 103	Monarc	12 mo	CST (negative)	OC: 94% vs 97%	-	-	-	OC: 0.78
			Monarc: 103			SC: Negative reply to ICIQ 3 and 5 and UI-SF	SC: 92% vs 94%
											SC: 0.50
Schellart et al[26]	RCT	173	MiniArc: 86	Monarc	12 mo	OC: CST	OC: 89% vs 91%				P = 0.65
			Monarc: 87			SC: PGI-I	SC: 83% vs 86%				P = 0.46
Basu et al[27]	RCT	71	MiniArc: 38	Advantage	36 mo			KHQ	48% vs 90%		All P < 0.05
			Advantage: 33
Oliveira et al[23,30]	Prosp.	71	MiniArc	-	12 mo	SC: No leakage and no protection	77%	Use of protection decreased > 50% and affirmative reply to the question: are you satisfied with the results?	11%	88%
Deole et al[29]	Prosp.	59	MiniArc		12 mo	OC: CST	OC: 66%	-	-	-	-
						SC: ICIQ-SF	SC: median score 6
						PGI-I	64%
Presthus et al[24]	Prosp.	31	MiniArc		24 mo	OC: CST and	93.5%
						PWT	90.3%
Kennelly et al[31]	Prosp. (Multi)	142	MiniArc		24 mo	OC: CST and	84.5%	-	-	-	-
						PWT	80.1%
						SC: UDI-6	92.9%

RCT: Randomized controlled trial; TOT: Trans obturator tape; OC: Objective cure; SC: Subjective cure; PGI-I: Patient global impression of improvement; CST: Cough stress test; PWT: Pad weight test; ITT: Intention to treat; PP: Per protocol; ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form; UI-SF: Urinary incontinence-Short form; UDI-6: Urogenital Distress Inventory; Prosp.: Prospective; Multi: Multicentric.

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.