Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Parkinson's Disease
• Intervention / Treatment: Drug: Oxybutynin and darifenacin

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • VA Medical Center, Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; crossover design	Drug: Oxybutynin and darifenacin; Participants with overactive bladder will take each medication for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
compare cognitive side effects	10 weeks

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Jayne R Wilkinson, MD, VA Medical Center, Philadelphia

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (ESTIMATE): May 4, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2014
• Last Update Submitted That Met QC Criteria: October 2, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: oxybutynin; cognition; Parkinson's disease; darifenacin; Overactive bladder symptoms
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Urinary Bladder, Overactive; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Oxybutynin; Darifenacin
• Other Study ID Numbers: 01143