Status:
COMPLETED
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Parkinson's Disease
Overactive Bladder
Eligibility:
All Genders
Phase:
NA
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 ...
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 medicat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00892450
Start Date
May 1 2009
End Date
September 1 2014
Last Update
October 3 2014
Active Locations (1)
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1
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104