Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial

Seoul National University Hospital5 sites in 1 country144 target enrollmentJuly 17, 2017

ConditionsOveractive Bladder Parkinson Disease

InterventionsMirabegron Placebo

DrugsMirabegron Placebo

Overview

Phase: Phase 4
Intervention: Mirabegron
Conditions: Overactive Bladder
Sponsor: Seoul National University Hospital
Enrollment: 144
Locations: 5
Primary Endpoint: Change in the total score of Overactive Bladder Symptom Scale(OABSS)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in patients with Parkinson's disease.

Detailed Description

This study is a randomized 1:1 placebo-controlled 12-week study of Mirabegron in 144 Parkinson's subjects the age of 40 to 80 with overactive bladder. Active drug will be Mirabegron 50mg daily. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 1. Enrolled subjects will have 3 study visits to the clinic as well as 1 phone visit.

Registry

clinicaltrials.gov

Start Date

July 17, 2017

End Date

December 31, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Seung-June Oh

Professor, Department of Urology

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•Subject who signed a consent form approved from IRB(Institutional Review Board) or IEC(Independent Ethics Committee)
•Diagnosis of Parkinson's disease by a neurologist
•taking a Parkinson's medications stably during 4 weeks preceding screening
•40 Years to 80 Years, Male and Female
•Patient has overactive bladder symptoms more than 4 weeks preceding screening.
•OABSS questionnaires total score≥ 3 and entries of urinary urgency score≥ 2
•The expanded disability status scale ≤ 7

Exclusion Criteria

•Subjects who have any intervention and operation which can influence on study such as bladder augmentation, vesical sphincter, artificial sphincter, intravesical botulinum toxin treatment etc.
•Use of indwelling catheter or self-catheterization
•acute urinary tract infection or urolithiasis 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
•total volume urine \> 3L a day
•Screening post-void residual \> 200ml
•Nonpharmacological therapy within the previous 4 weeks of screening
•screening blood pressure \>180 systolic or 110 diastolic
•subjects who have orthostatic hypotension, syncope, hypokalemia, or angle-closure glaucoma
•Clinically Significant ECG in recent year

Arms & Interventions

Mirabegron

1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg.

Intervention: Mirabegron

Placebo

1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg.

Intervention: Placebo

Outcomes

Primary Outcomes

Change in the total score of Overactive Bladder Symptom Scale(OABSS)

Time Frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)

Change in the total score of Overactive Bladder Symptom Scale(OABSS) from baseline(Visit 2) to Visit 4

Secondary Outcomes

Change in the total score of TSQ (Treatment Satisfaction Questionnaire)(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the Mean number of Urinary incontinence(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the total score of IPSS(International Prostate Symptom Score)(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the total score of OAB-q short form(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the total score of GRA (Global Response Assessment)(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the total score of PPBC(Patient Perception of Bladder Condition)(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the score of BSW (Benefit, Satisfaction and Willingness to Continue Questions)(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the Mean Frequent Urination(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the Mean number of Urinary urgency(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))
Change in the total score of OABSS(Overactive Bladder Symptom Scale)(Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2))