Fesoterodine on Urgency Episodes in Parkinson's Disease Population

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02385500
• Date of registration: 04/03/2015
• Prospective Registration: Yes
• Primary sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Public title: Fesoterodine on Urgency Episodes in Parkinson's Disease Population
• Scientific title: Randomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease Population
• Date of first enrolment: September 2016
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02385500
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Lysanne Campeau, MD, PhD
• Affiliation: Sir Mortimer B. Davis - Jewish General Hospital

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Bladder, Overactive

Parkinson Disease

Intervention(s)

Drug: Fesoterodine

Drug: Placebo

Primary Outcome(s)

Urgency episodes [Time Frame: 10 weeks and 20 weeks]

Secondary Outcome(s)

Patient's severity of overactive bladder symptoms as measured by OAB-Q score [Time Frame: 10 weeks and 20 weeks]

Patient's urgency perception as measured by the UPS score [Time Frame: 10 weeks and 20 weeks]

Cognitive ability as measured by the MOCA score [Time Frame: 10 weeks and 20 weeks]

Nocturnal sleep disturbances measured by Parkinson's Disease Sleep Scale [Time Frame: 10 weeks and 20 weeks]

Patient's perception of his bladder condition as measured by PPBC score [Time Frame: 10 weeks and 20 weeks]

Urgency urinary incontinence episodes [Time Frame: 10 weeks and 20 weeks]

Micturitions [Time Frame: 10 weeks and 20 weeks]

Severe urgency episodes [Time Frame: 10 weeks and 20 weeks]

Incontinence pads used [Time Frame: 10 weeks and 20 weeks]

Nocturnal micturitions [Time Frame: 10 weeks and 20 weeks]

Safety of fesoterodine in Parkinson's Disease population [Time Frame: 10 weeks and 20 weeks]

Secondary ID(s)

15-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors