Objective
To identify clinical and demographic characteristics that moderate response to treatment with fesoterodine among women diagnosed with urgency-predominant urinary incontinence (UUI).
Methods
A multicenter, double-blinded, 12-week randomized controlled trial of pharmacologic therapy for urgency-predominant urinary incontinence in community-dwelling women diagnosed by the 3-item Incontinence Questionnaire (3IQ) was previously performed. Participants (N = 645) were randomized to fesoterodine therapy (4–8 mg daily; N=322) or placebo (N=323). Urinary incontinence was assessed by 3-day voiding diaries. In this secondary analysis, a “responder” was defined as ≥50% reduction in overall incontinence episode frequency compared to baseline. Clinical and demographic characteristics that may moderate treatment response were assessed by testing for interaction between characteristics and intervention in logit models of responders, adjusting for clinical site.
Results
Participants were mean (SD) 56 (±14) years old, 68% were white race, and had 3.9 (±3.0) urgency incontinence episodes per day. There were no baseline differences in demographic, clinical or incontinence characteristics between treatment and placebo groups or between responders and non-responders. There was an increase in the proportion of responders to fesoterodine with increasing age (p=0.04) and parity (0.04), and among married women (p=0.03), but no effect modification was observed by race/ethnicity, body mass index, education, employment status, alcohol or tobacco use.
Conclusions
In ambulatory women with UUI, older age, being married, and higher parity significantly moderated and potentiated the effects of pharmacologic therapy on incontinence frequency. This study identifies certain populations who may have increased responsiveness to treatment with antimuscarinic therapy and may be used to inform and guide future therapy.