Randomized controlled trial comparing single‐incision mini‐sling and transobturator midurethral sling for the treatment of stress urinary incontinence: 3‐year follow‐up results

Abstract

TOT was associated to higher objective cure rate than SIMS for SUI treatment although satisfaction rate was similar for both groups 3 years postoperative.

Safety and Efficacy of Single Incision Sling Versus Midurethral Sling in the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial

“…The ICS/IUGA classification system was used to standardize complication rates. Tape exposure rates (1.5% in SIS and 3.1% in TOT groups) and lower urinary tracts symptoms including urine retention (3.0% in the SIS group and 4.6% in the TOT group) were in accordance with other reports 17,18,21 . Although not statistically significant, our mini sling surgical procedures were associated with slightly more revision procedures owing to SUI recurrence compared with TOT slings (7.6% vs 6.3%).…”

“…Loss to follow-up rates reported in our trial were 21.4% in SIS group and 23.8% in TOT group. These rates were better or equivalent to previously published randomized trials with 2- or 3-year follow-up time 17,21 . Within our 4-year observation interval, it was challenging for both patients and physicians to maintain commitment.…”

“…Single-incision sling usage within the SUI treatment is still controversial, rendering a critical need for additional studies that will elucidate its place in surgical management. Few well-designed prospective studies have reported encouraging short- and medium-term SIS outcomes, 17–20 although other research findings substantiated opposite results 21 . Overall analysis of our 4-year follow-up RCT primarily demonstrates SUI surgery noninferiority with adjustable SIS in relation to inside-out TOT sling regarding both subjective and objective cure.…”

“…Similar midterm results were affirmed in a study evaluating the Contasure-needleless SIS system reported by Dogan et al 18 Conversely, another RCT specifically assessing Ophira SIS efficacy after 3 years indicated inferiority of this sling in comparison with TOT sling in both subjective and objective cure rates (68.3% vs 85.4%). Possible explanation for this inconsistency might be inclusion of complex cases with prior anti-incontinence surgery and adoption of rigorous objective cure criteria, including the CST along with a pad weight test 21 . Long-term follow-up (over 3 years) data evaluating SIS are available only from 1 retrospective observational study, in which Lo et al 23 reported MiniArc SIS efficacy with 84.7% objective and 80.0% subjective cure rates.…”

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?

“…Some authors report comparable outcomes of SIMS for woman with SUI,[ 14 15 16 ] but other authors report inferior outcomes as compared to TOT and TVT. [ 17 18 ] Based on the lack of robust evidence to draw firm conclusion, our study was aimed to compare cure rates, urogynecological symptoms, complications, patient satisfaction and safety of SISM, TVT, and TOT procedures for female SUI.…”