Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial

Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended‐release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB). PATIENTS AND METHODS In this 12‐week double‐blind, double‐dummy, placebo‐controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3‐day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency‐urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB‐q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12‐week study period. RESULTS Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P