Randomized, controlled pilot trial of solifenacin succinate for overactive bladder in Parkinson's disease.

Abstract

OBJECTIVE:

To evaluate the efficacy of solifenacin succinate in Parkinson's disease (PD) patients suffering from overactive bladder (OAB).

BACKGROUND:

Urinary dysfunction is a commonly encountered non-motor feature in PD that significantly impacts patient quality of life.

DESIGN/METHODS:

This was a double-blind, randomized, placebo-controlled, 3-site study with an open label extension phase to determine the efficacy of solifenacin succinate in idiopathic PD patients with OAB. Patients were randomized to receive solifenacin succinate 5-10 mg daily or placebo for 12 weeks followed by an 8-week open label extension. The primary outcome measure was the change in the mean number of micturitions per 24 h period. Secondary outcome measures included the change in the mean number of urinary incontinence episodes and the mean number of nocturia episodes.

RESULTS:

Twenty-three patients were randomized in the study. There was no significant improvement in the primary outcome measure in the double-blind phase, but there was an improvement in the number of micturitions per 24 h period in the solifenacin succinate group compared to placebo at a mean dose of 6 mg/day (p = 0.01). In the open label phase, the mean number of urinary incontinence episodes per 24 h period decreased (p = 0.03), as did the number of nocturia episodes per 24 h period (p = 0.01). Adverse events included constipation and xerostomia, which resolved after treatment was discontinued.

CONCLUSIONS:

In this pilot trial, solifenacin succinate treatment led to an improvement in urinary incontinence, despite persistence in other OAB symptoms.

• Authors: Theresa A Zesiewicz, Marian Evatt, Camille P Vaughan, Israt Jahan, Carlos Singer, Raul Ordorica, Jason L Salemi, Jessica D Shaw, Kelly L Sullivan, Non-Motor Working Group of the Parkinson Study Group (PSG)
• Journal: Parkinsonism & related disorders (Parkinsonism Relat Disord) Vol. 21 Issue 5 Pg. 514-20 (May 2015) ISSN: 1873-5126 [Electronic] England
• PMID: 25814050 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Ltd. All rights reserved.

Chemical References

• Urological Agents
• Solifenacin Succinate

Topics

• Double-Blind Method
• Female
• Humans
• Male
• Parkinson Disease (diagnosis, drug therapy, epidemiology)
• Pilot Projects
• Solifenacin Succinate (therapeutic use)
• Urinary Bladder, Overactive (diagnosis, drug therapy, epidemiology)
• Urinary Incontinence (diagnosis, drug therapy, epidemiology)
• Urological Agents (therapeutic use)