Anticholinergic Therapy for Overactive Bladder in Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00892450
First received: April 28, 2009
Last updated: November 26, 2013
Last verified: November 2013

April 28, 2009
November 26, 2013
May 2009
December 2013   (final data collection date for primary outcome measure)
compare cognitive side effects [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00892450 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
December 2013
December 2013   (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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00892450
01143
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Jayne R. Wilkinson, MD VA Medical Center, Philadelphia
Department of Veterans Affairs
November 2013

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