Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

Not Applicable

Completed

• Conditions: Overactive Bladder; Parkinson's Disease
• Interventions: Drug: Oxybutynin and darifenacin

• Registration Number: NCT00892450
• Lead Sponsor: US Department of Veterans Affairs

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 in veteran patients with Parkinson's disease (PD) seen at the Philadelphia PADRECC.

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.

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-30
• Study Start: 2009-05
• Study First Posted: 2009-05-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Oxybutynin and darifenacin	crossover design

Primary Outcome Measures

Name	Time	Method
compare cognitive side effects	10 weeks

Trial Locations

Locations (1)

VA Medical Center, Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States