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

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 4 mg or placebo for 4 weeks. At the end of 4 weeks of randomization phase, patients were received fesoterodine fumarate 4 mg daily for another 4 weeks at the open-label extension phase. The change in the mean number of micturition episodes per 24 h period was the primary outcome measure of the study.

The number of micturition episodes per 24 h 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 4 weeks of fesoterodine 4 mg 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 4 mg treatment compared with placebo.