URGE-PD: A Multi-Site, Double-Blind, Randomized, Placebo-Controlled Trial of Solifenacin succinate (VESIcare®) for the Treatment of Overactive Bladder in Parkinson’s Disease

Document Type

Conference Abstract

Publication Date

6-8-2014

Publication Title

Proceedings of the Movement Disorders Society International Congress of Parkinson's Disease and Movement Disorders

Abstract

Objective: To evaluate the safety and efficacy of solifenacin succinate (VESIcare®) in Parkinson's disease patients suffering from overactive bladder (OAB).

Background: Urinary dysfunction is a commonly encountered non-motor feature in many idiopathic Parkinson's disease (PD) patients. While antimuscarinic drugs are often used to treat urinary symptoms, there are no controlled trials to evaluate their efficacy in PD.

Methods: This was a double-blind, randomized, placebo-controlled, 3-site study that evaluated the efficacy of solifenacin succinate (VESIcare®) in idiopathic PD patients with overactive bladder (OAB) defined as at least 8 voids per 24-hr period and at least daily urinary urgency. Patients were randomized to receive solifenacin succinate 5mg or placebo for 6 weeks, and were offered the option to increase the dose to 10mg daily based upon clinical need, or continue with 5 mg daily. The primary outcome was the change in mean number of micturitions per 24 hour period as recorded on a 3-day bladder diary 12 weeks after randomization; secondary objectives included the change in the mean number of urinary incontinence episodes, the mean number of nocturia episodes, urinary urgency as measured by the The Patient Perception of Intensity of Urgency Scale (PPIUS), and the mean change in Patient Perception of Bladder Condition (PBC/PPBC). The Unified Parkinson's disease Rating Scale (UPDRS) was performed at each 6-week interval visit.

Results: Twenty-eight patients enrolled in the study (60% men, mean age 67.04±7.88 years (range 52-79 years)); 3 patients discontinued the study due to side effects of constipation, xerostomia and urinary rentention that resolved upon medication discontinuation. At endpoint, the mean number of urinary incontinence episodes per 24 hour period decreased significantly in the solifenacin group compared to placebo (1.48 ± 2.56 to 0.30 ± 0.31 versus 1.78 ± 1.27 to 1.61 ± 1.40, p=0.01), at a mean dose of 6mg/day. There was a trend for improvement in the motor section of the UPDRS in the solifenacin group (9.89 ± 5.58 to 8.11 ± 5.37 versus 11.75 ± 4.58 to 11.75 ± 3.98, p=0.09).

Conclusions: Use of solifenancin succinate (VESIcare®) led to a significant improvement in urinary incontinence in PD patients, and was generally well tolerated. Further studies are needed to evaluate treatment of urinary dysfunction in PD.

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