Fesoterodine on Urgency Episodes in Parkinson's Disease Population

• Status: Terminated
• Trial end date: 2019-06-07
• Target enrollment: 0
• Participant gender: All

Summary

Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary tract dysfunction. Their symptoms can be managed with antimuscarinics with variable efficacy. Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary frequency, urgency and nocturia in this patient population. The purpose of this protocol is to compare the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep problems in a heterogeneous population of PD patients in a cross-over fashion.

A representative number of patients with baseline overactive bladder (OAB) symptoms and Parkinson's disease will be recruited to receive either the active drug or placebo for the first phase of eight weeks. The groups will then be crossed-over during the second phase of eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale (PDSS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Treatments: Fesoterodine

Criteria

Inclusion Criteria:

• Age between 50-85 years-old

• self-reported OAB symptoms for ≥3 months

• a mean of ≥8 micturitions/ 24 hr

• ≥3 urgency episodes/24 hr on a 3-day bladder diary

• at least "some moderate problems" on the Patient Perception of Bladder Condition (PPBC)

• Montreal cognitive assessment (MOCA) score ≥24

• Stable dose of dopaminergic medications and levodopa (between 300 and 1200 mg daily)

Exclusion Criteria:

• Urinary retention: PVR >150 ml (as assessed by bladder scan)

• Contra-indications to fesoterodine

• Unwilling to stop current antimuscarinics

• Patients on anticholinergics for motor disturbances

• Dementia based on clinical evaluation

• Atypical Parkinsonian syndrome

• Deep brain stimulation

• Presence of hallucination