Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

NCT ID: NCT00892450

Last Updated: 2014-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

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.

Conditions

Parkinson's Disease; Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

crossover design

Group Type: EXPERIMENTAL

Oxybutynin and darifenacin

Intervention Type: DRUG

Participants with overactive bladder will take each medication for 4 weeks.

Interventions

Oxybutynin and darifenacin

Participants with overactive bladder will take each medication for 4 weeks.

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayne R Wilkinson, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Philadelphia

Locations

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

01143

Identifier Type: -

Identifier Source: org_study_id