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Title: Collagen Denaturation of Bladder Neck Can Correct Stress Incontinence: Presented at ACOG
URL: http://www.pslgroup.com/dg/2212E2.htm
Doctor's Guide
May 13, 2008


By Martha Kerr, BSN

NEW ORLEANS -- May 13, 2008 -- More than two-thirds of women treated by transurethral radiofrequency collagen denaturation (TRCD) had a greater than 50% reduction in episodes of stress incontinence, according to research presented here at the 56th Annual Meeting of the American College of Obstetricians and Gynecologists (ACOG).

The researchers also found that nearly half of the women with urinary stress incontinence in this study reported having no more episodes after they underwent TRCD.

Long-term follow-up also showed that this treatment modality has safety and durability, according to a study.

The 3-year results obtained with TRCD were presented by principal investigator Denise M. Elser, MD, Director, Oak Lawn Division, Illinois Urogynecology LTD, Oak Lawn, Illinois, and Assistant Clinical Professor, University of Illinois, Chicago, Illinois.

The study involved 136 women with a history of stress incontinence of at least 12 months' duration who had not responded to conservative management. At baseline, the women had 2.9 episodes of stress leaks daily and 20.3 episodes per week. Mean Incontinence-Quality of Life (I-QOL) score was 51.3 and mean Urogenital Distress Inventory-6 (UDI-6) score was 52.7.

Dr. Elser presented 12-month follow-up data on 73 of the 136 women who underwent the procedure in her office.

Mean change in I-QOL score was 19.6 points (P = .0001), and mean improvement in UDI-6 score was 21.1 points (P = .0001).

Dr. Elser said that 45% of the women no longer have episodes of incontinence. Overall, 69% of patients reported a 50% or greater reduction in leaked volume on the stress pad weight test. Median reduction was 15.2 g per episode (P < .0001).

The procedure involves insertion of a radiofrequency catheter into the bladder outlet. Bursts of radiofrequency cause microscopic collagen denaturation at several discrete areas within the bladder neck and proximal urethral submucosa.

"The new collagen that forms is much stiffer" than the denatured collagen it replaces, Dr. Elser said. "It is this stiffness that reduces stress leaks."

Complete healing takes 2 to 3 months to take place, and durability has been sustained for up to 3 years of follow-up, Dr. Elser said. "And we are seeing no decay [in efficacy] over time."

The procedure is completed in about 30 minutes, and there have been no adverse reactions or urinary obstruction, she said. "Some women have some minor burning afterward, but this is temporary and they can void normally by the time they leave the office," Dr. Elser said.

The TRCD procedure was performed on an outpatient basis during an office visit, which Dr. Elser said was "very important" to her patients. "Since the procedure can be done in our office, it offers our patients privacy and confidentiality," she noted.

"By age 40, at least one-quarter of women have stress incontinence, but the number could be much higher" as patients are reluctant to report symptoms, she noted.

"We don't know yet if the procedure can be repeated" should the bladder outlet begin to weaken, "but we haven't seen this with as long as 3 years of follow-up," Dr. Elser said.

Funding for this study was provided in part by Novasys Medical Inc.


[Presentation Title: Long-Term Durability of Nonsurgical, Transurethral Radiofrequency Collagen Denaturation for the Treatment of Female Stress Urinary Incontinence. Poster 116]

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