Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease



Status:Completed
Conditions:Overactive Bladder, Parkinsons Disease
Therapuetic Areas:Gastroenterology, Neurology
Healthy:No
Age Range:Any
Updated:11/30/2013
Start Date:May 2009
End Date:December 2013
Contact:Heidi C Watson
Email:heidi.watson@va.gov
Phone:(215) 823-5800

Use our guide to learn which trials are right for you!

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.


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.

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
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials