Efficacy and Safety of the Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder
Status:
Completed
Trial end date:
2017-12-30
Target enrollment:
Participant gender:
Summary
Overactive bladder (OAB) is a chronic symptom complex that can substantially impair quality
of life. Pharmacological management using antimuscarinics agent remain the mainstay of
therapy and effectively reduce OAB symptoms. However, despite the proven efficacy of such
agents, their tolerability may be limited by adverse events, mostly dry mouth. In fact these
adverse events often lead to poor compliance and discontinuation of therapy.The
β3-adrenoceptor agonist, mirabegron, which acts via a different mechanism of action to
antimuscarinics, could potentially improve the efficacy/ tolerability balance over current
standard of care in the management of OAB.β3-adrenoceptor agonists relax detrusor smooth
muscle during the bladder storage phase and increase bladder capacity without negatively
affecting voiding parameters. Different study has report efficacy and safety of mirabegron
but not done in our country.
Investigators will evaluate the efficacy and safety of mirabegron comparison with solifenacin
succinate in the treatment of overactive bladder.This is a hospital based prospective
randomized controlled clinical trial will be conducted from July 2016 to November 2017 in the
department of urology, Bangabandhu Sheikh Mujib Medical University (BSMMU). Among the patient
with overactive bladder who will visit to Urology outpatient department (OPD) of BSSMU, 56
patient who will fulfil the inclusion criteria will be selected. Selected patients will be
evaluated by history, physical examinations and investigation like routine urine analysis &
culture, serum creatinine, random blood sugar, X-ray kidney, ureter & bladder (KUB)
region,ultrasonogram (USG) of KUB region with maximum cystometric capacity (MCC) &
post-viodal residue (PVR). After taking informed consent, selected 82 patient will be
randomly divided in to experimental group and control group, each containing 41 patients. All
patients will be entered into one week run-in period, when they will instructed to stop any
drug including any anti-cholinergics, if they are getting it before. Patient will be supplied
with a Bengali version micturition diary from and instructed to complete a 3 day voiding
diary. Average of three day will be calculated for 24 hours.Overactive symptom score will be
calculated by interviewing the patient for urinary symptom for last 7 days. Experimental
group will receive Mirabegron 25mg and control group will receive solifenacin succinate 5 mg
all are at night for 12 weeks. Patients in both group will be regularly followed up 12 weeks
at 4 weeks interval.Patient will be supplied with a Bengali version micturition diary from
and instructed to complete a 3 day voiding diary in each follow up schedule visit at the end
of 4, 8 and 12 weeks. Overactive symptom score will be calculated by interviewing the patient
for urinary symptom for last 7 days in each visit.Patient will be evaluated for any adverse
effects during the medication. Data will be collected, complied, computed and appropriate
statistical analysis will be done as per objectives
Phase:
Phase 4
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh