Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study.

STUDY OBJECTIVE To assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility. DESIGN Continuing, prospective, 36-month, open-label, single-arm clinical trial. Twelve-month results from intent-to-treat (ITT) analysis are reported. Canadian Task Force classification II-2. SETTING Thirteen physician offices or ambulatory treatment centers. PATIENTS Women with SUI secondary to bladder outlet hypermobility for 12 months or longer who failed earlier conservative treatment and had not received earlier surgical or bulking agent therapy. INTERVENTIONS Women were treated as outpatients and received an oral antibiotic and local periurethral anesthesia before undergoing treatment with transurethral radiofrequency collagen denaturation. MEASUREMENTS AND MAIN RESULTS Voiding diaries and in-office stress pad weight tests yield objective assessments. Subjective measures include the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Patient Global Impression of Improvement (PGI-I) instruments. In total, 136 women received treatment (ITT population). Patients experienced significant reductions versus baseline in median number of leaks caused by activity/day and activity/week (p <.0026 for both), with 50% of patients reporting 50% or more reduction. Pad weight tests revealed that 69% of women had 50% or more reduction in leakage (median reduction 15.2 g; p <.0001); 45% were dry (29% no leaks; 16% < 1-g leakage). Significant improvements occurred in median scores on the I-QOL (+9.5 [range -66.0 to 91.0]; p <.0001) and mean scores on the UDI-6 (-14.1 +/- 24.7; p <.0001). Furthermore, 71.2% showed I-QOL score improvement, including 50.3% with 10-point or greater improvement, and 49.6% reported on the PGI-I that they were "a little," "much," or "very much" better. CONCLUSION At 12 months, treatment of SUI with nonsurgical transurethral collagen denaturation resulted in significant improvements in activity-related leaks and quality of life.