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

• Urinary dysfunction is a common non-motor feature in PD that significantly impacts patient quality of life.
• This double-blind, pilot trial evaluated the efficacy of solifenacin succinate in idiopathic PD patients with OAB.
• Twenty-three patients were randomized to treatment for 12 weeks followed by 8-weeks of open label extension.
• The mean number of urinary incontinence episodes per 24 h period decreased significantly in the solifenacin group.
• The open label phase found reductions in the mean number of urinary incontinence episodes and the number of nocturia episodes.

ObjectiveTo evaluate the efficacy of solifenacin succinate in Parkinson's disease (PD) patients suffering from overactive bladder (OAB).BackgroundUrinary dysfunction is a commonly encountered non-motor feature in PD that significantly impacts patient quality of life.Design/methodsThis 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.ResultsTwenty-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.ConclusionsIn this pilot trial, solifenacin succinate treatment led to an improvement in urinary incontinence, despite persistence in other OAB symptoms.