Randomized, controlled trial of fesoterodine fumarate for overactive bladder in Parkinson's disease.

Abstract

To evaluate short-term efficacy and safety of fesoterodine fumarate in Parkinson's disease (PD) patients with overactive bladder (OAB) symptoms. This is a randomized, double-blind, placebo-controlled study. It also has an open-label extension phase. From May 2016 to May 2018, 63 patients were randomized to receive fesoterodine 4mg or placebo for 4weeks. At the end of 4weeks of randomization phase, patients were received fesoterodine fumarate 4mg daily for another 4 weeks at the open-label extension phase. The change in the mean number of micturition episodes per 24h period was the primary outcome measure of the study. The number of micturition episodes per 24h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001). Also the mean number of nocturia and urgency episodes decreased in the fesoterodine group. In the open-label phase, the mean number of micturition, urgency and urgency urinary incontinence episodes were improved significantly. The number of nocturia episodes did not change in the open-label phase. Cognitive functions were stable after 4weeks of fesoterodine 4mg treatment. OAB symptoms were significantly improved in older adults with PD under fesoterodine fumarate treatment, and this advantage continued in the open-label portion in the short term. In this randomized controlled study, the cognitive functions of the participants were not affected by fesoterodine 4mg treatment compared with placebo.