Full Text View
Tabular View
No Study Results Posted
Related Studies
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
This study is enrolling participants by invitation only.
First Received: April 28, 2009   Last Updated: May 1, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00892450
  Purpose

The purpose of this research study is to investigate the cognitive (thinking, memory, knowledge, intelligence) side effects of two medications commonly used to treat overactive bladder (OAB) symptoms in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.


Condition Intervention
Parkinson's Disease
Overactive Bladder
Drug: Oxybutynin and darifenacin

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Darifenacin Darifenacin hydrobromide Oxybutynin chloride Oxybutynin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title: Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-Blind, Crossover Pilot Study

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • compare cognitive side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: May 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
crossover design
Drug: Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.

Detailed Description:

This study will be a double-blinded cross-over clinical trial design to assess the prevalence of cognitive effects, the efficacy, and the effect on quality of life (QOL) of two anticholinergic medications commonly used in the treatment of overactive bladder (OAB): oxybutynin and darifenacin. This will be done by use of a well-established and validated computer-based cognitive battery. Secondary endpoints will assess efficacy of anticholinergic therapy on symptoms of OAB via QOL questionnaire and participant urinary diaries.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 65 or older
  2. Diagnosis of idiopathic PD (ICD9=332.0)
  3. MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
  4. Urological work-up within 3 months of enrollment to:

    • Rule out treatable causes of urinary symptoms

      • Urinalysis (UA)
      • Post-void residual ultrasound (PVR)
      • Urinary cytology
    • Documented symptoms OAB on screening 3-day voiding diary:

      • Average of 1 urgency episode / 24 hours, and
      • Average of 8 micturitions / 24 hours
      • Subjective complaints of symptoms for 3 months

Exclusion Criteria:

  1. Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
  2. Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
  3. Exposure to drugs contraindicated or cautioned in use with the 2 study medications (drugs that also use the cytochrome P450 enzyme, primarily CYP3A4). These include: ketoconazole, itraconazole, miconazole, erythromycin, clarithromycin, ritonavir, nelfinavir, nefazodone, flecainide, thioridazine and tricyclic antidepressants.
  4. Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
  5. Uncontrolled narrow angle glaucoma
  6. History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
  7. History of hepatic or renal impairment
  8. History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
  9. Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892450

Locations
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Jayne R. Wilkinson, MD VA Medical Center, Philadelphia
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs ( Wilkinson, Jayne - Principal Investigator )
Study ID Numbers: 01143
Study First Received: April 28, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00892450     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Overactive bladder symptoms
Parkinson's disease
darifenacin
oxybutynin
cognition

Study placed in the following topic categories:
Oxybutynin
Urinary Bladder, Overactive
Neurotransmitter Agents
Ganglion Cysts
Cystocele
Cholinergic Antagonists
Basal Ganglia Diseases
Urinary Bladder Diseases
Central Nervous System Diseases
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases
Muscarinic Antagonists
Signs and Symptoms
Darifenacin
Urologic Diseases
Parkinson Disease
Movement Disorders
Peripheral Nervous System Agents
Parkinsonian Disorders

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Parasympatholytics
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Basal Ganglia Diseases
Physiological Effects of Drugs
Neurodegenerative Diseases
Brain Diseases
Cholinergic Agents
Signs and Symptoms
Urologic Diseases
Movement Disorders
Oxybutynin
Urinary Bladder Diseases
Nervous System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Darifenacin
Parkinson Disease
Autonomic Agents
Parkinsonian Disorders
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009