Introduction and hypothesis: The aim was to evaluate, using urethral pressure reflectometry (UPR), the effect of fesoterodine on urethral function in women with stress urinary incontinence (SUI).
Methods: Women aged 18 to 65 years were eligible for this randomised, double-blind, placebo-controlled, crossover study if they had had clinically significant SUI or SUI-predominant mixed urinary incontinence for >3 months. Each participant received fesoterodine 4 mg, fesoterodine 8 mg, and placebo once daily for 7 days, with a 7- to 10-day washout between treatments. UPR was performed at baseline and 4 to 8 h after the last dose in each treatment period. Participants completed a 3-day bladder diary before randomisation and during the last 3 days of each treatment period.
Results: Of the 22 women randomly assigned and treated, 17 met the criteria for the primary efficacy analyses. No statistically significant differences were seen between fesoterodine 4 mg or fesoterodine 8 mg and placebo in opening urethral pressure (primary endpoint) or other UPR endpoints. No statistically significant differences were seen between either fesoterodine dose and placebo in the change from baseline in the bladder diary variables (total urinary incontinence, SUI, or urgency urinary incontinence episodes per 24 h). Adverse events were reported by 8 participants taking fesoterodine 4 mg, 17 taking fesoterodine 8 mg, and 8 taking placebo.
Conclusions: Fesoterodine did not affect urethral pressure or significantly decrease the number of incontinence episodes in women with SUI. The UPR parameters showed no placebo effect, while there was a placebo effect of 60 % based on the bladder diary.
Trial registration: ClinicalTrials.gov NCT01042236.