Clinical trial NCT00892450: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Overactive Bladder
Keywords: Overactive bladder symptoms
Parkinson's disease
darifenacin
oxybutynin
cognition
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-05-04
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: compare cognitive side effects
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
Study officials:
affiliation: VA Medical Center, Philadelphia
name: Jayne R Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: