A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease. (MAESTRO)
Overview
- Phase
- Phase 4
- Intervention
- Mirabegron
- Conditions
- Parkinsons Disease
- Sponsor
- Daniel Burdick, MD
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to see if the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in people with Parkinson's Disease.
Detailed Description
This study is a randomized 1:1 placebo-controlled 10-week study of Mirabegron as add-on therapy to an educational intervention of behavioral modification including pelvic floor exercise (PFE) in a cohort of 40 Parkinson's subjects over the age of 30 with overactive bladder (OAB). Active drug will be Mirabegron 25 mg daily with up-titration to 50 mg daily after 5 weeks. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 2. Enrolled subjects will have 4 study visits to the clinic as well as 2 phone visits. Enrolled subjects will be asked to record urinary symptoms and pelvic floor exercises in a diary at 3 separate time points for a 72 hour period.
Investigators
Daniel Burdick, MD
Principal Investigator
Burdick, Daniel, M.D.
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Parkinsons by United Kingdom brain bank criteria
- •Age \> 30 years old
- •No change in Parkinsons medications during the 4 weeks preceding screening, with no dose changes during the study, except that PRN (as needed) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
- •Patient willing and able to complete micturition diary
- •Urinary urgency (≥ 8 entries of bladder urgency score \> 2) in 72hr voiding diary during screening period
- •Micturition frequency ≥ 8 / 24hr or incontinence ≥ 2 episodes in 72hr voiding diary during screening period
- •Use of other medication that could influence bladder function, other than those specifically prohibited (see below), will be permitted as long as the dose is stable for 4 weeks preceding screening, with no dose changes during the study.
- •Patient expects to have valid health insurance for the duration of the study period
Exclusion Criteria
- •Women who are breast-feeding, pregnant or have potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
- •Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
- •Screening blood pressure \> 165 systolic or 100 diastolic
- •Heart rate \> 100
- •History of allergy to Mirabegron.
- •Screening post-void residual \> 200ml
- •Evidence of urinary tract infection at screening
- •History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
- •Intravesical botulinum toxin treatment within the previous six months of screening.
- •Presence of Interstim device
Arms & Interventions
Mirabegron
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 mg daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or, for those in the placebo arm, two placebo tablets.
Intervention: Mirabegron
Placebo
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
Time Frame: 7-82 days. From visit 2 (baseline) to visit 4
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Secondary Outcomes
- Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)(baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2))
- Subjects Global Impression of Change(baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2))
- Non- Motor Symptoms Scale (NMSS)(baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2))
- Patient Perception of Bladder Condition(baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2))