BACKGROUND: Until 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.
METHODS: We performed a pragmatic, noninferiority, randomized trial comparing mini-slings 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.
RESULTS: A 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.
CONCLUSIONS: Single-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. (Funded by the National Institute for Health Research.).
Bibliographical noteSupported by the NIHR (NIHR Evaluation, Health Technology Assessment Programme; funder number, 12/127/157).
We thank all the SIMS trial patients without whom this trial would not have been possible; the members of the independent trial steering committee (Chris Mayne [chair], Isobel Montgomery, Dudley Robinson, Lynda Harper, Eleanor Mitchell, and Khaled Ismail) for their supervision of the trial and their guidance and support; the members of the independent data monitoring committee (Peter Brocklehurst [chair], Lee Middleton, Christian Phillips, and Doug Tincello) for their work in assessing all serious adverse events reported to the trial office in real time; Phil Assassa for his substantive role in the trial, including the obtaining of funding, the design of the protocol, and the recruitment of patients; Athele Khunda for his role in patient recruitment and for his contribution to the trial; and Ahmed Mansor and Katie Gillespie for their contribution with the systematic review.
- Patient Reported Outcome Measures
- Pragmatic Clinical Trials as Topic
- Prosthesis Implantation/adverse effects
- Quality of Life
- Suburethral Slings/adverse effects
- Surgical Mesh
- Treatment Outcome
- United Kingdom
- Urinary Incontinence, Stress/surgery