A single-incision mini-sling worked just as well as the standard midurethral sling in women with stress urinary incontinence (SUI), a randomized study found.
At 15 months, 79.1% of women who received the mini-sling reported success compared with 75.6% of those who received the midurethral sling (P<0.001 for noninferiority), said Mohamed Abdel-Fattah, MD, of Aberdeen Maternity Hospital in Scotland, and colleagues.
This difference was similar at 36-month follow-up, with success — defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire — reported by 72.0% and 66.8% of patients, respectively, they noted in the New England Journal of Medicine.
“A key point from this trial is that after the placement of either type of urethral sling, most women reported a decrease in urinary incontinence,” wrote Ingrid Nygaard, MD, and Peggy Norton, MD, both of the University of Utah School of Medicine in Salt Lake City, in an accompanying editorial. “However, fewer than one third in each group reported having a ‘cure’ (i.e., no urinary leakage) at 36 months.”
Specifically, a post-hoc analysis showed that cure occurred in 38.6% of patients in the mini-sling group versus 33.2% of those in the midurethral-sling group at 15 months, and in 32.4% and 30.7%, respectively, at 36 months.
“The success of a continence procedure depends on its definition, which can include various subjective and objective measures or a combination of measures,” Nygaard and Norton pointed out.
The single-incision mini-sling was designed to minimize operation time and to decrease complications associated with surgery for the treatment of SUI. With limited data on the effectiveness and safety of mini-slings compared with midurethral slings, Abdel-Fattah and colleagues sought to compare the two among 596 women (mean age 50-51, mean BMI about 29) randomized 1:1 at 21 U.K. hospitals.
Mini-sling procedures were more likely to be performed with the patient under local anesthesia (72.8%), while midurethral sling procedures were more likely to be performed under general anesthesia (91.2%).
While the percentage of patients with groin or thigh pain was higher in the mini-sling group than in the midurethral-sling group at 15 months (14.9% vs 11.9%), these rates were similar between groups at 36 months (14.1% vs 14.9%).
About twice as many patients who received mini-slings underwent further surgical treatment over follow-up compared with patients who received midurethral slings (8.7% vs 4.6%), including for urinary incontinence (4.3% vs 2.3%), pain (2.5% vs 0.8%), and mesh exposure (2.5% vs 1.1%).
Quality of life and sexual function outcomes were similar between the two groups, with the exception of dyspareunia, which was experienced by 11.7% of women in the mini-sling group compared with 4.8% in the midurethral-sling group.
“This trial provides evidence that mesh surgeries for stress urinary incontinence are safe and effective — data that are important both for restoring confidence in such surgeries and potentially for increasing their availability,” Nygaard and Norton concluded.
Disclosures
The study was supported by the National Institute for Health Research.
Abdel-Fattah and co-authors reported no disclosures.
The editorialists reported no disclosures.
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