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

NCT00584090 | Withdrawn Phase 4

• 2 other identifiers: 4104803b
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Parkinson's Disease

Keywords

urinary incontinence; parkinson's disease; vesicare; solifenacin succinate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Solifenacin Succinate (VESIcare)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Solifenacin Succinate (VESIcare) DRUG

5 - 10 mg po qd for 1 month

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Parkinson Disease

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Theresa A Zesiewicz, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2011
• Last Updated: December 3, 2012

Record last verified: 2010-10

Locations

US (1)