Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease

NCT00584090•University of South Florida

Summary

The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients. The secondary objective of this study is to examine the effect of solifenacin succinate (VESIcare) on symptoms of PD and the patient's quality of life.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
•2. Age 30 years to 80 years.
•3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
•4. Patients must score 18 or higher on the UPDRS scale and 1.0 to 2.5 on the Modified Hoehn and Yahr scale.
•5. Women of child-bearing potential must use a reliable method of contraception.
•6. Must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
•7. Patients must have evidence of normal PSA and urodynamic tests within the last 12 months.
•8. Clearance from the patient's urologist or internist who has examined the patient within the last 12-months.

Exclusion Criteria

•1. Any illness that in the investigator's opinion preclude participation in this study.
•2. Pregnancy or lactation.
•3. Concurrent participation in another clinical study.
•4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
•5. Legal incapacity or limited legal capacity.
•6. Presence of severe renal disease (BUN 50% greater than normal).
•7. Presence of major hepatic impairment.
•8. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor.
•9. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
•10. History of controlled narrow angle glaucoma.

Locations (1)

University of South Florida

Tampa, Florida, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

April 1, 2011

Last Updated

December 3, 2012

Conditions

Urinary IncontinenceParkinson's Disease

Interventions

Solifenacin Succinate (VESIcare)

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

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