Single-Incision Mini-Slings for Stress Urinary Incontinence in Women

Abstract

BACKGROUNDUntil recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODSWe performed a pragmatic, noninferiority, randomized trial comparing minislings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTSA total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], −2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, −1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONSSingle-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up.

The role of spinal surgery in the treatment of low back pain

“…Transparent multicentre trials independent from industry are fundamental to more adequately establish the benefit of modern surgical techniques and move beyond this impasse. Consistent with previous trials in the spinal 55 and non‐spinal 56 , 57 , 58 literature, these trials should be independent from industry and be supported by philanthropic and governmental research funding agencies. In a similar vein, the methodological flaws and systemic biases present within the existing literature must be acknowledged.…”

Single Incision Mini-Sling Versus Mid-Urethral Sling (Transobturator/Retropubic) in Females With Stress Urinary Incontinence: A Systematic Review and Meta-Analysis

“…The literature review initially yielded 1750 articles. After removing duplicates and screening studies based on their titles and abstracts, seventeen [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] studies were found, including retrospective and prospective ones. Comparative studies comprised the entirety of those included in this meta-analysis.…”

“…This collection of articles spans the years 2011 through 2023. Six of the seventeen articles were observational cohort studies [20,[22][23][24]26,27], and the other eleven were controlled trials [13][14][15][16][17][18][19]21,25,28,29]. Of the eleven controlled trials, nine were randomized controlled trials (RCTs), one was a controlled clinical trial (CCT) [18], and one was a quasi-randomized trial [15].…”

“…Seven included studies [13][14][15][16][17][18]21] were single-center, and the remaining were multicenter. All studies included a transobturator mid-urethral sling in the control group, except for two studies [25,26] that included a public mid-urethral sling along with the transobturator sling in the control group. The mean follow-up duration was 33 months.…”

“…FIGURE 2: Quality assessment of included Randomized controlled trials (RCTs)Source: References:[13][14][15][16][17][18][19]21,25,28,29] …”