Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00892450
First received: April 28, 2009
Last updated: October 2, 2014
Last verified: October 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study

Resource links provided by NLM:


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 ]

Enrollment: 12
Study Start Date: May 2009
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic PD (ICD9=332.0)
  • MMSE 24, able to give informed consent and complete questionnaires and voiding diaries.
  • 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:

  • Exposure to anticholinergics or antispasmodics within the last 4 weeks (among them: atropine, tolterodine, benztropine, trihexyphenidyl, dicyclomine, hyoscyamine, and scopolamine)
  • Exposure to drugs with known effects on cognition (i.e. opioids, benzodiazepines or sedating antihistamines) within the last week
  • 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.
  • Nonpharmacological treatment of OAB within the last 4 weeks (for example: biofeedback, physical therapy, acupuncture)
  • Uncontrolled narrow angle glaucoma
  • History of gastric or urinary retention / dysmotility (ulcerative colitis, myasthenia gravis and severe constipation)
  • History of hepatic or renal impairment
  • History of severe gastro-esophageal reflux disease and/or use of bisphosphonates, patients at risk for esophagitis
  • Previous exposure to anticholinergic for OAB symptoms that resulted in side effects that caused cessation of the medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00892450     History of Changes
Other Study ID Numbers: 01143
Study First Received: April 28, 2009
Last Updated: October 2, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 19, 2014