Eighteen-Month Results of a Three-Year Trial of Nonsurgical Transurethral Collagen Denaturation for Stress Urinary Incontinence
Denise Elser, MD1, Gretchen Mitchell, MD2, John Miklos, MD2, Kevin Nickell, MD3, Kevin Cline, MD4, Harvey Winkler, MD5, W. Glen Wells, MD6.
1Illinois Urogynecology, LTD, Oaklawn, IL, USA, 2Atlanta Urogynecology Associates, Alpharetta, GA, USA, 3Houston Metro Urology, Sugarland, TX, USA, 4Regional Urology, LLC, Shreveport, LA, USA, 5North Shore Women’s Health, Great Neck, NY, USA, 6Alabama Research Center, LLC., Birmingham, AL, USA.
Study Objective: Nonsurgical, transurethral radiofrequency collagen denaturation, a safe one-time treatment for stress urinary incontinence due to bladder outlet hypermobility, is performed in an office setting in approximately 30 minutes using local anesthesia. This clinical trial aims to determine its long-term effectiveness. Design: A 3-year prospective, single-arm study with evaluations conducted thus far at baseline and 3, 6, 12, and 18 months following treatment. We report 18-month results. Setting: Thirteen physician offices or ambulatory treatment centers. Patients: Women with stress urinary incontinence due to bladder outlet hypermobility for ≥12 months who failed conservative treatment and did not have urge/mixed incontinence or prior definitive treatment (surgery, bulking agents). Interventions: Women received preoperative oral antibiotic and local periurethral lidocaine injection. Procedure was then performed as previously described (Appell et al, Neurourol Urodyn; 2006;25:331-5). Measurements and Main Results: Patients completed Incontinence Quality of Life (I-QOL), Patient Global Impression of Improvement (PGI-I), and Urogenital Distress Inventory (UDI-6) measures and recorded SUI episodes. Adverse events and responses to patient satisfaction questions were noted. In all, 136 women (mean age, 47 years; range, 26-87 years) received treatment. At baseline, mean number of leaks due to activity was 2.1/day (15.0/week); median I-QOL score was 53.0; mean UDI-6 score was 52.5. At 18 months, 59 patients were evaluated. 63% had ≥50% leak reduction, with median reduction from baseline of 10 leaks/week. Mean I-QOL score improved 22.7 points (median 20 points), with 66% having ≥10-point improvement. On PGI-I, 71% reported being “a little,” “much,” or “very much” improved. Mean UDI-6 improvement was 13.2 points, with stress incontinence subscore improvement of 17.3 points. Overall, 61% of patients were “somewhat” or “very” satisfied and 64% would recommend the procedure to a friend. No serious adverse events occurred at any time posttreatment. Conclusions: Nonsurgical collagen denaturation showed measurable durable improvement at 18 months.