The study aims to prospectively evaluate the 12-month effectiveness, safety, and patient-reported outcomes of a lightweight polypropylene transobturator mid-urethral sling in women undergoing surgical treatment for stress urinary incontinence (SUI).

This prospective, multicenter, observational post-market clinical study was conducted at five hospitals in Catalonia, Spain. Women aged 18 years or older who had been diagnosed with SUI and were scheduled to have transobturator mid-urethral sling surgery were enrolled and followed for 12 months. The evaluated device was a lightweight (43 g/m²) polypropylene sling (GyneBand, Mallanets™) designed to minimize foreign body load while maintaining suburethral support.
The main effectiveness outcomes were objective continence, which was measured by the cough stress test, and symptom severity, which was measured by the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). These were measured before the surgery and again at 1, 6, and 12 months after the surgery. Safety outcomes comprised systematic assessment of intraoperative, early, and late complications. Secondary outcomes included quality of life and patient-reported measures assessed using the EQ-5D-5L, Patient Global Impression of Improvement (PGI-I), and International Consultation on Incontinence Questionnaire–Overactive Bladder (ICIQ-OAB). Within-patient comparisons were performed using paired statistical tests with 95% confidence intervals.

Seventy-five women were included in the final analysis, with 92% completing 12-month follow-up. The proportion of patients with a positive cough stress test decreased significantly from 85.3% preoperatively to 8.8% at 12 months (p < 0.001). Mean ICIQ-UI SF scores improved from 15.2 at baseline to 4.3 at 12 months, corresponding to a mean reduction of −10.9 points (95% CI −12.5 to −9.3; p < 0.001), well exceeding established thresholds for clinical relevance.
Quality of life improved significantly, with EQ-5D-5L visual analog scale scores increasing by approximately 10 points at 12 months (p<0.001). At final follow-up, 82.6% of patients reported feeling “better” or “much better” on the PGI-I, and more than 90% reported cure or improvement.
The safety profile was favorable. At 12 months, 95.7% of patients remained free of late complications. One case of mesh extrusion was observed (1.5%), with no major intraoperative injuries, chronic pain, urinary retention, or thromboembolic events reported.

In this prospective multicenter post-market evaluation, a lightweight polypropylene transobturator mid-urethral sling demonstrated sustained objective and subjective effectiveness, significant improvements in quality of life, and a favorable safety profile at 12 months.

These findings support the use of a lightweight polypropylene transobturator mid-urethral sling as an effective and safe option for women with SUI