Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00892450
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : October 3, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

April 28, 2009
May 4, 2009
October 3, 2014
May 2009
September 2014   (Final data collection date for primary outcome measure)
compare cognitive side effects [ Time Frame: 10 weeks ]
Same as current
Complete list of historical versions of study NCT00892450 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease
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.
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Overactive Bladder
Drug: Oxybutynin and darifenacin
Participants with overactive bladder will take each medication for 4 weeks.
Experimental: Arm 1
crossover design
Intervention: Drug: Oxybutynin and darifenacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Jayne R Wilkinson, MD VA Medical Center, Philadelphia
VA Office of Research and Development
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP