Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease

NCT01018264 | Completed Phase 4 Results

• 1 other identifier: URGE-PD
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.

Conditions

Overactive Bladder in Parkinson's Disease

Keywords

Overactive bladder; Urinary incontinence; Urinary frequency; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Number of Micturations Per 24 Hour Period

  The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries.

  12 weeks

Secondary Outcomes (4)

• Number of Urinary Incontinence Episodes Per 24 Hour Period

  12 weeks

• Unified Parkinson's Disease Rating Scale (UPDRS) Total

  12 weeks

• Parkinson's Disease Quality of Life Scale (PDQOL)

  12 weeks

• Number of Nocturia Episodes Per 24 Hour Period

  12 weeks

Study Arms (2)

solifenacin succinate (VESIcare)

EXPERIMENTAL

Drug: solifenacin succinate (VESIcare)

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

solifenacin succinate (VESIcare) DRUG

up to 10mg every day orally

solifenacin succinate (VESIcare)

placebo DRUG

placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

placebo

Eligibility Criteria

• Age: 40 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 40 years to 80 years.
• Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
• Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale.
• Women of child-bearing potential must use a reliable method of contraception.
• Must be experiencing symptoms of overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months.
• The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician).
• The patient must have had a bladder scan within six months of the screening visit. This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline.
• Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 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 scores less than 27).
• Legal incapacity or limited legal capacity.
• History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
• Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit.
• Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
• Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
• Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
• History of narrow angle glaucoma.
• Patients who have undergone pelvic radiation at any time.
• Currently taking any of the following medications:
• Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps)
• Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril)

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence; Parkinson Disease

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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; Urination Disorders; 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

Results Point of Contact

• Title: Theresa Zesiewicz, MD, Professor of Neurology
• Organization: University of South Florida

tzesiewi@health.usf.edu

813-974-5909

Study Officials

• Theresa Zesiewicz, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 9, 2021
• Results First Posted: May 27, 2015

Record last verified: 2021-11

Locations

US (3)