Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892450
• Other study ID #: 01143
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: October 2, 2014
• Start date: May 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Parkinson Disease
• Parkinson's Disease
• Urinary Bladder, Overactive

Intervention

Drug:
• Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.

Locations

Country	Name	City	State
United States	VA Medical Center, Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare cognitive side effects		10 weeks	Yes