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
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.
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
VA Medical Center, Philadelphia, Philadelphia, Pennsylvania 19104, United States
Additional Information
Starting date: May 2009
Last updated: October 2, 2014
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