Long-term efficacy and safety of questionnaire-based initiation of urgency urinary incontinence treatment

OBJECTIVES: To determine the longer-term efficacy and safety of initiating treatment for urgency-predominant urinary incontinence (UUI) in women diagnosed using a simple questionnaire rather than an extensive evaluation. STUDY DESIGN: Women completing a 12-week randomized controlled trial of fesoterodine therapy for UUI diagnosed by questionnaire were invited to participate in a 9-month open label continuation study. UUI and voiding episodes were collected using voiding diaries. Participant satisfaction was measured by questionnaire. Safety was assessed by measurement of post void residual volume and adverse event monitoring; if necessary, women underwent specialist evaluation. Longitudinal changes in UUI and voiding episodes were evaluated using linear mixed models adjusting for baseline. RESULTS: Of the 567 women completing the randomized trial, 498 (87.8%) took at least one dose of medication during this open label study. Compared to the enrollment visit in the randomized trial, fesoterodine was associated with a reduction in total incontinence episodes/day and urgency incontinence episodes/day at the end of the open label study [adjusted mean (standard error (SE)) 4.6 (0.12) to 1.2 (0.13) and 3.9 (0.11) to 0.9 (0.11) respectively, p-value<.0001 for both]. Most women were satisfied with treatment (89%, 92%, and 93% at 3, 6, and 9 months). Twenty-six women experienced 28 serious adverse events, one of which was considered possibly treatment-related. Twenty-two women had specialist evaluation: 5 women’s incontinence was misclassified by the 3IQ; none experienced harm due to misclassification. CONCLUSIONS: Using a simple validated questionnaire to diagnose and initiate treatment for UUI in community dwelling women is safe and effective, allowing timely treatment by primary care practitioners