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.
The study titled, "Single-Incision Mini-Slings for Stress Urinary Incontinence in Women," was published in the New England Journal of Medicine.
KEYWORDS: stress urinary incontinence, NEJM, midurethral slings, mini slings, surgical treatment, women, Mohamed Abdel-Fattah, patient reported success, surgery, single incision
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted at email@example.com. Contact no. 011-43720751