Mini-slings non-inferior to mid-urethral slings for female stress urinary incontinence: NEJM
USA: A recent study in the New England Journal of Medicine showed single-incision mini-slings to be noninferior to standard mid-urethral slings in women with stress urinary incontinence with regards to patient-reported success at 15 months. Also, at the 36-month follow-up, the percentage of patients reporting success remained similar in the two groups.
Synthetic mid-urethral slings (made of mesh or tape) are the standard surgical treatment globally for female stress urinary incontinence in cases of failure of conservative management. However, there is a lack of data comparing the safety and effectiveness of newer single-incision mini-slings with those of standard mid-urethral slings. To fill this knowledge gap, Mohamed Abdel-Fattah and colleagues performed a pragmatic, multicenter, noninferiority, randomized, controlled trial (the SIMS trial) comparing outcomes of adjustable anchored mini-slings with those of tension-free mid-urethral slings in women with stress urinary incontinence at 21 U.K. hospitals during 36 months of follow-up.
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) was the primary outcome. The noninferiority margin was 10 percentage points.
298 women were assigned to receive mini-slings and 298 were assigned to receive mid-urethral slings.
Key findings of the study include:
- 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 mid-urethral-sling group (adjusted risk difference, 4.6 percentage points).
- 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).
- At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with mid-urethral 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 mid-urethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively.
- Outcomes with respect to the 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 mid-urethral-sling group.
To conclude, single-incision mini-slings were noninferior to standard mid-urethral 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.
Reference:
The study titled, "Single-Incision Mini-Slings for Stress Urinary Incontinence in Women," was published in the New England Journal of Medicine.
DOI: https://www.nejm.org/media/doi/full/10.1056/NEJMoa2111815
KEYWORDS: stress urinary incontinence, NEJM, midurethral slings, mini slings, surgical treatment, women, Mohamed Abdel-Fattah, patient reported success, surgery, single incision
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