A disposable adhesive patch for stress urinary incontinence.

BACKGROUND AND OBJECTIVES: Stress urinary incontinence (SUI) affects 5 million women in the United States. Current surgical and pharmacological management options are often unsuccessful, forcing many sufferers to rely on bulky and uncomfortable sanitary protection. This study evaluated the safety, efficacy, and acceptability of a small, disposable adhesive patch designed to seal the urethral opening and prevent urine leakage. METHODS: Thirty-seven women with mild-to-moderate SUI were recruited from a suburban community. Each volunteer participated in a 21-week protocol that included a 1-week qualifying period, 4-week (pretest) control period, 12-week patch-use period, and 4-week (posttest) control period. Patch efficacy was evaluated with quantitative (leakage into sanitary napkin) and qualitative (voiding diary) measures of urine leakage. Symptom questionnaires were also completed. RESULTS: Overall leakage was reduced by 60%, from 1.1 +/- .3 standard error of the mean (SEM) to .44 +/- .11 (SEM) grams of urine per hour. Perception of dryness, measured by voiding diaries, improved 67%, from 13.3 +/- 1.9 (SEM) to 4.3 +/- 0.9 (SEM) leakage episodes per week. Safety evaluation included peri-urethral cytology, urinalysis and urine culture, and vaginal cultures. All measures were unaffected by 3 months of patch use. Acceptability was assessed with questionnaires that measured the impact of patch use on activities of daily living and overall quality of life. Women reported a significant improvement in both measures. All but one volunteer found that the patch was comfortable and were able to place it correctly between the inner labia with written instructions only. CONCLUSIONS: The disposable patch significantly reduced urine leakage resulting from SUI in community-based women. Dryness improved significantly, both by measurement of actual leakage and by the subject's perception of dryness. The maturation index of the vestibular tissues showed an increase in the number of superficial cells during patch use. Otherwise, there were no significant changes in vulvar tissues, urine composition, or microbial flora (in vaginal and urine samples). Volunteers reported that the patch improved their overall quality of life.