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2008 Annual Meeting Abstracts
Durability Trial of Transurethral Radiofrequency Collagen Denaturation for Treatment of Stress Urinary Incontinence: Efficacy Results at 12 Months
Denise M Elser*1, Gretchen K Mitchell*2
1Illinois Urogynecology, LTD, Oak Lawn, IL;2Atlanta Urogynecology Associates, Alpharetta, GA
Introduction and Objective: Nonsurgical, transurethral collagen denaturation, a safe one-time treatment for stress urinary incontinence (SUI) due to bladder outlet hypermobility, is performed in an office setting in ≈30 minutes. This trial evaluates long-term effectiveness.
Methods: An ongoing 3-year prospective study has evaluated patients at baseline, 3, 6, and 12 months. Study includes women with SUI for ≥12 months who failed prior conservative treatment. Women with urge/mixed incontinence or prior definitive treatment (surgery, bulking agents) were excluded. Women received a local periurethral lidocaine injection and procedure was performed (see Appell et al, Neurourol Urodyn 2006;25:331-335). Patients completed Incontinence Quality of Life (I-QOL), Patient Global Impression of Improvement (PGI-I), and Urogenital Distress Inventory (UDI-6) instruments, recorded daily SUI episodes, and underwent a 1-hour stress pad weight test. Twelve-month results are reported.
Results Obtained: Study enrolled 139 women (mean age, 47y; range 26-87y); 136 received treatment. Mean baseline number of leaks was 3.8/day; mean I-QOL and UDI-6 scores were 51.3 and 52.3. At 6 months, 119 patients were evaluated; 63.1% had ≥50% leak reduction. Mean I-QOL and UDI-6 improvements were 16.4 and 17.3 points (both P<.0001). At 12 months, 73 patients were evaluated; 69% reported ≥50% reduction in leaked volume (median reduction, 15.2g) on pad test (P<.0001). Pad test revealed that 45% of women were dry (29%, no leaks;16%, <1g leakage). Mean change in I-QOL from baseline was 19.6 points (P=.0001); 74% had improved UDI-6 scores (mean improvement, 17.6 points; P=.0001).
Conclusions: Nonsurgical collagen denaturation showed measurable durable improvement at 12 months.
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