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

This study has been withdrawn prior to enrollment.

( Study withdrawn with intent of persuing larger, multi-site study. )

First Received on December 21, 2007. Last Updated on October 5, 2010 History of Changes

Sponsor:	University of South Florida
Information provided by:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00584090

Purpose

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.

Condition	Intervention	Phase
Urinary Incontinence Parkinson's Disease	Drug: Solifenacin Succinate (VESIcare) Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease Urinary Incontinence

Drug Information available for: Succinic acid Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:

The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Solifenacin Succinate (VESIcare) 5 - 10 mg po qd for 1 month
Placebo Comparator: 2	Drug: Placebo Placebo equivalent of 5-10 mg po qd for 1 month

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584090

Locations

United States, Florida
University of South Florida
Tampa, Florida, United States, 33612

Sponsors and Collaborators

University of South Florida

Investigators

Principal Investigator:

Theresa A Zesiewicz, MD

University of South Florida

More Information

No publications provided

Responsible Party:	Theresa Zesiewicz, MD, University of South Florida
ClinicalTrials.gov Identifier:	NCT00584090 History of Changes
Other Study ID Numbers:	4, 104803b
Study First Received:	December 21, 2007
Last Updated:	October 5, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Florida:

urinary incontinence
parkinson's disease
vesicare
solifenacin succinate

Additional relevant MeSH terms:

Urinary Incontinence
Parkinson Disease
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Movement Disorders
Neurodegenerative Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012