Disclosure: No investigator received financial support or equity for trial participation.
Original Clinical Article
Article first published online: 27 MAY 2010
Copyright © 2010 Wiley-Liss, Inc.
Neurourology and Urodynamics
Volume 29, Issue 8, pages 1424–1428, November 2010
How to Cite
Elser, D. M., Mitchell, G. K., Miklos, J. R., Nickell, K. G., Cline, K., Winkler, H. and Wells, W. G. (2010), Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol. Urodyn., 29: 1424–1428. doi: 10.1002/nau.20875
Heinz Koelbl led the review process.
- Issue published online: 25 OCT 2010
- Article first published online: 27 MAY 2010
- Manuscript Accepted: 1 DEC 2009
- Manuscript Received: 1 OCT 2009
- Novasys Medical, Inc.
- bladder outlet hypermobility;
- collagen denaturation;
- patient satisfaction;
- quality of life;
- stress urinary incontinence
To evaluate 18-month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women.
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.
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.
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. Neurourol. Urodynam. 29:1424–1428, 2010. © 2010 Wiley-Liss, Inc.