Twelve-Month Interim Results From a Three-Year Clinical Trial of Nonsurgical Transurethral Collagen Denaturation in Women With Stress Urinary Incontinence

Back to 77th Annual Meeting
Back to Program Outline

Background: Nonsurgical, transurethral radiofrequency collagen denaturation, a one-time treatment for women with stress urinary incontinence (SUI) due to bladder outlet hypermobility, is performed in an office setting in about 30 minutes using local anesthesia. This clinical trial aimed to demonstrate its long-term effectiveness.
Methods: A 3-year prospective study has conducted patient evaluations at baseline and 3, 6, and 12 months following treatment at 13 physician offices or ambulatory surgery centers in the US. The study includes women with SUI due to bladder outlet hypermobility for ≥12 months who failed prior conservative treatment. Women with urge or mixed urinary incontinence or who had prior definitive treatment (eg, incontinence surgery or bulking agents) were excluded. Patients received pretreatment oral antibiotic, oral sedative if requested, and local periurethral lidocaine injection. Device was positioned in the bladder and radiofrequency energy was delivered in 1-minute increments (9 minutes total), resulting in collagen denaturation of 36 circumferential sites from the bladder neck to the proximal urethral submucosa. Patients kept 7-day bladder diaries at baseline and at 12, 24, and 36 months, and completed the Incontinence Quality of Life (I-QOL) questionnaire, Patient Global Impression of Improvement (PGI-I) scale, and Urogenital Distress Inventory (UDI-6). Patients underwent a 1-hour in-office stress pad weight test. Adverse events, changes in concomitant medications, and responses to satisfaction questions were noted. Twelve-month results are reported.
Results: One hundred thirty-six women received treatment. Most returned to normal daily activities within 1-2 days. At baseline, mean number of leaks due to stress as reported in diaries was 3.8/d; number of leaks due to activity was 2.9/d. Mean I-QOL and UDI scores were 51.3 and 52.7. At 6 months, patients experienced significant reductions in daily and weekly stress leaks (both P<.0001), with 63.1% of patients reporting ≥50% reduction. Mean I-QOL and UDI-6 scores improved (16.4 ± 26.1, P=.0001, and -17.6 ± 24.5, P=.0001, respectively). No serious adverse events were reported. At 12 months, 73 patients were evaluated. Mean number of stress leaks reported was 1.9/d. Additionally, 69% reported ≥50% reduction in leaked volume (median reduction, 15.2g) on the stress pad weight test (P<.0001), which revealed that 45% of women evaluated were dry (29%, no leaks; 16%, <1g leakage). Mean change in I-QOL scores from baseline was 19.6 points (P=.0001); 74% had improved UDI-6 scores. Mean UDI-6 improvement was 17.6 points (P=.0001). On the PGI-I scale, 42.3% of patients reported their incontinence was very much or much better versus baseline. Among women assessed at 12 months, 35.1% reported they would definitely or probably recommend transurethral collagen denaturation to a friend with SUI versus 14.2% who probably or definitely would not. Of note, intent-to-treat analysis showed no characteristic differences between patients lost to follow-up and those evaluated at 6 and 12 months.
Conclusions: Transurethral collagen denaturation showed measurable durable improvement at 12 months, with no serious adverse events reported at any time point following treatment. This treatment may allow SUI patients to avoid burdensome treatment and compliance requirements of other nonsurgical therapies.

Back to 77th Annual Meeting
Back to Program Outline