Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study.

Abstract

AIMS:

To evaluate 18-month safety and durability of efficacy of nonsurgical transurethral collagen denaturation as treatment for stress urinary incontinence (SUI) in women.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Denise M Elser, Gretchen K Mitchell, John R Miklos, Kevin G Nickell, Kevin Cline, Harvey Winkler, W Glen Wells
• Journal: Neurourology and urodynamics (Neurourol Urodyn) Vol. 29 Issue 8 Pg. 1424-8 (Nov 2010) ISSN: 1520-6777 [Electronic] United States
• PMID: 20976817 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2010 Wiley-Liss, Inc.

Chemical References

• Collagen

Topics

• Adult
• Aged
• Aged, 80 and over
• Collagen (chemistry)
• Diathermy (adverse effects, methods)
• Female
• Humans
• Middle Aged
• Patient Satisfaction
• Prospective Studies
• Protein Denaturation
• Quality of Life
• Time Factors
• Treatment Outcome
• United States
• Urinary Bladder (physiopathology)
• Urinary Incontinence, Stress (physiopathology, psychology, therapy)