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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00584090
• Other study ID #: 4
• Secondary ID: 104803b
• Status: Withdrawn
• Phase: Phase 4
• First received: December 21, 2007
• Last updated: November 30, 2012
• Start date: November 2007

Study information

• Verified date: October 2010
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Urinary Incontinence

Intervention

Drug:
• Solifenacin Succinate (VESIcare)
5 - 10 mg po qd for 1 month
• Placebo
Placebo equivalent of 5-10 mg po qd for 1 month

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients.		1 month	No
Secondary	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.		1 month	No