Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study.

摘要

AIMS: To evaluate 18-month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women. METHODS: Study comprised women with SUI due to bladder outlet hypermobility for at least 12 months who failed conservative treatment and had not undergone surgery or bulking agent treatment. This one-time procedure was performed in a physician's office or ambulatory treatment center. Patients kept voiding diaries and completed the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement measures at baseline and at 3, 6, 12, and 18 months posttreatment. RESULTS: At 18 months, intent-to-treat analysis revealed that patients experienced significant reductions in the median number of stress leaks daily (0.43; P < 0.006) and weekly (3.0; P < 0.006) versus baseline, with 46.7% reporting a 50% or greater reduction in leakage. Mean I-QOL score improved 10.9 points (median 8.5; P < 0.0001), with 47.8% having a 10-point or greater improvement and 50.4% reporting improved symptoms versus baseline. Mean UDI-6 improvement was 13.0 points, with a stress incontinence subscore improvement of 17.0 points. Overall, 47.0% of patients were "somewhat" or "very" satisfied, and 52.9% would recommend the procedure to a friend. The procedure was shown to be safe and effective, with no new treatment-related adverse events reported at 18 months. CONCLUSIONS: Transurethral collagen denaturation resulted in significant improvements in stress leaks and quality of life for at least 18 months. This procedure offers a safe, effective, nonsurgical treatment option for women with SUI.