A bladder-neck support prosthesis for women with stress and mixed incontinence

Objective:To evaluate the safety and efficacy of a bladder-neck support;pro sthesis, a vaginal device designed to support the bladder neck,in women wit h genuine stress and mixed incontinence. Methods: For enrollment, incontinent women underwent a history, physical ex amination including cotton-swab test, urinalysis, postvoid residual urine,a nd multichannel urodynamic testing. Those with genuine stress incontinence or mixed incontinence and urethral hypermobility completed 7-day bladder di aries, the Incontinence Impact Questionnaire, and underwent standardized pa d 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-f itting 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 m ixed incontinence (range 30-88). A statistically significant reduction in i ncontinence 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 (ge nuine stress incontinence, mean 28.6-7.8 losses per week; mixed incontinenc e, mean 30.2-15 losses per week). Quality-of-life scores improved in both g roups. With the device in place, urodynamic testing indicated normalization of urethral function without evidence of outflow obstruction. Subjects fou nd the device comfortable, easy to use, and convenient. Side effects includ ed five urinary tract infections and 23 cases of vaginal mucosal soreness o r mild irritation. Conclusion: The bladder-neck support prosthesis significantly reduced invol untary urine loss in women with stress and mixed incontinence. (Obstet Gyne col 1999;93:938-42. (C) 1999 by The American College of Obstetricians and G ynecologists.)