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Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease; Overactive Bladder

Intervention: Oxybutynin and darifenacin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Jayne R Wilkinson, MD, Principal Investigator, Affiliation: VA Medical Center, Philadelphia


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: compare cognitive side effects

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of idiopathic PD (ICD9=332. 0)

- MMSE 24, able to give informed consent and complete questionnaires and voiding


- 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

Locations and Contacts

VA Medical Center, Philadelphia, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: May 2009
Last updated: October 2, 2014

Page last updated: August 23, 2015

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