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Efficacy and Safety of the Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder

NCT03558919 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2018-06-19

No results posted yet for this study

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

Conditions

Interventions

DRUG

Mirabegron 25mg

DRUG

Solifenacin Succinate 5 MG

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-12-30
Completion
2017-12-30
FDA Drug
Yes

Countries

  • Bangladesh

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03558919 on ClinicalTrials.gov