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Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxybutynin and darifenacin
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Overactive bladder symptoms, Parkinson's disease, darifenacin, oxybutynin, cognition

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Medical Center, Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

crossover design

Outcomes

Primary Outcome Measures

compare cognitive side effects

Secondary Outcome Measures

Full Information

First Posted
April 28, 2009
Last Updated
October 2, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00892450
Brief Title
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
Official Title
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Overactive Bladder
Keywords
Overactive bladder symptoms, Parkinson's disease, darifenacin, oxybutynin, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
crossover design
Intervention Type
Drug
Intervention Name(s)
Oxybutynin and darifenacin
Intervention Description
Participants with overactive bladder will take each medication for 4 weeks.
Primary Outcome Measure Information:
Title
compare cognitive side effects
Time Frame
10 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayne R Wilkinson, MD
Organizational Affiliation
VA Medical Center, Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

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