Long-term Efficacy and Safety of Questionnaire-Based Initiation of Urgency Urinary Incontinence Treatment

Abstract

A large number of women with urinary incontinence do not receive appropriate care because of delays in diagnosis resulting from failure of primary care providers to ask routine questions about incontinence as well as failure of patients to volunteer information. Diagnosis of incontinence only after referral to specialists increases the cost of care and delays treatment. A simple, brief questionnaire-based screening instrument has been developed to allow primary care providers to diagnose and treat urgency-predominant urinary incontinence (UUI) in women without more extensive specialist evaluation. The longer-term efficacy and safety of treating patients with incontinence based on this questionnaire are unknown.

This open-label multicenter study was designed to determine the longer-term efficacy and safety of initiating treatment for women with UUI diagnosed using the questionnaire rather than an extensive evaluation. The study was conducted between February 2009 and January 2010. Participants were 567 women who completed a 12-week placebo-controlled randomized trial of an antimuscarinic drug for UUI diagnosed by a questionnaire; 498 (87.8%) of these women agreed to enroll in a preplanned 9-month, open-label continuation study. The antimuscarinic used in both the randomized portion and open-label portion of the study was fesoterodine administered daily. Participants were seen in person at the open-label baseline and at 1, 3, 6, and 9 months and were contacted by telephone at 2 weeks. Safety was assessed by measuring post void residual volume and monitoring adverse events; when necessary, women were evaluated by a specialist. Linear mixed models with adjustment for baseline were used to evaluate longitudinal changes in UUI and voiding episodes.

At the end of the open-label study, compared with the baseline visit in the randomized trial, fesoterodine was associated with a reduction in total incontinence episodes per day (adjusted mean [SE], 4.6 [0.12] reduced to 1.2 [0.13]) and urgency incontinence episodes per day (3.9 [0.11] reduced to 0.9 [0.11]; P < .0001 for both). Most women who continued in the open-label study were satisfied with treatment (89%, 92%, and 93% at 3, 6, and 9 months, respectively). A total of 28 serious adverse events were experienced by 26 women; only 1 case was considered to be possibly related to treatment. During the open-label study, 83 women were offered extended evaluations. Of the 22 women who completed extended evaluations, only 5 were considered by the specialist to be misclassified by the incontinence questions; none of these patients experienced harm because of the misclassification.

These findings demonstrate the safety and effectiveness of using a simple validated questionnaire to diagnose and initiate treatment for UUI in a population of community-dwelling women. The data suggest that use of the questionnaire is likely to allow timely treatment in a primary care setting of many patients with UUI without the need for referral to a specialist.