MedDataX Logo

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

NCT ID: NCT00584090

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence Parkinson's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

urinary incontinence parkinson's disease vesicare solifenacin succinate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Solifenacin Succinate (VESIcare)

Intervention Type DRUG

5 - 10 mg po qd for 1 month

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo equivalent of 5-10 mg po qd for 1 month

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Solifenacin Succinate (VESIcare)

5 - 10 mg po qd for 1 month

Intervention Type DRUG

Placebo

Placebo equivalent of 5-10 mg po qd for 1 month

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of South Florida

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Theresa A Zesiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida

Tampa, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

104803b

Identifier Type: -

Identifier Source: secondary_id

4

Identifier Type: -

Identifier Source: org_study_id