Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
Primary Purpose
Urinary Incontinence, Parkinson's Disease
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solifenacin Succinate (VESIcare)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, parkinson's disease, vesicare, solifenacin succinate
Eligibility 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.
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
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.
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.
Full Information
NCT ID
NCT00584090
First Posted
December 21, 2007
Last Updated
November 30, 2012
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT00584090
Brief Title
Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn with intent of persuing larger, multi-site study.
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Parkinson's Disease
Keywords
urinary incontinence, parkinson's disease, vesicare, solifenacin succinate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate (VESIcare)
Intervention Description
5 - 10 mg po qd for 1 month
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo equivalent of 5-10 mg po qd for 1 month
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa A Zesiewicz, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease
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