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Obstetrics & Gynecology 1999;93:938-942
© 1999 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

A Bladder-Neck Support Prosthesis for Women With Stress and Mixed Incontinence

G. WILLY DAVILA, MD, DURWOOD NEAL, MD, NICOLETTE HORBACH, MD, JORGE PEACHER, MD, J. DARRYL DOUGHTIE, MD and MICKEY KARRAM, MD

From the Colorado Gynecology and Continence Center, Denver, Colorado; University of Texas Medical Branch, Galveston, Texas; Fairfax Hospital, Fairfax, Virginia; South Texas Women’s Center for Incontinence and Laser Surgery, San Antonio, Texas; John Peter Smith Hospital, Fort Worth, Texas; and Good Samaritan Hospital, Cincinnati, Ohio.

Address reprint requests to: G. Willy Davila, MD Colorado Gynecology and Continence Center, P.C. 4600 Hale Parkway, #340 Denver, CO 80220 E-mail: nsx4wd{at}aol.com

Objective: To evaluate the safety and efficacy of a bladder-neck support prosthesis, a vaginal device designed to support the bladder neck, in women with genuine stress and mixed incontinence.

Methods: For enrollment, incontinent women underwent a history, physical examination including cotton-swab test, urinalysis, postvoid residual urine, and multichannel urodynamic testing. Those with genuine stress incontinence or mixed incontinence and urethral hypermobility completed 7-day bladder diaries, the Incontinence Impact Questionnaire, and underwent standardized pad tests. They were fitted with a prosthesis and seen weekly to optimize fit and efficacy. At week 5, they underwent repeat evaluations with the best-fitting prosthesis in place.

Results: Seventy women were enrolled and 53 completed the 1-month study (29 genuine stress incontinence, 24 mixed incontinence). The mean ages were 50.4 years for genuine stress incontinence (range 24–76) and 55.7 years for mixed incontinence (range 30–88). A statistically significant reduction in incontinence was noted on pad testing (genuine stress incontinence, mean 46.6–16.6 g; mixed incontinence, mean 31.9–6.8 g) and in the bladder diary (genuine stress incontinence, mean 28.6–7.8 losses per week; mixed incontinence, mean 30.2–15 losses per week). Quality-of-life scores improved in both groups. With the device in place, urodynamic testing indicated normalization of urethral function without evidence of outflow obstruction. Subjects found the device comfortable, easy to use, and convenient. Side effects included five urinary tract infections and 23 cases of vaginal mucosal soreness or mild irritation.

Conclusion: The bladder-neck support prosthesis significantly reduced involuntary urine loss in women with stress and mixed incontinence.




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Regular review: Management of urinary incontinence in women
BMJ, November 25, 2000; 321(7272): 1326 - 1331.
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