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

NCT03558919 | Completed Phase 4 FDA Drug

• 1 other identifier: Mirabegron
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Overactive symptom score (OABSS)

  Overactive bladder symptom score Patients are instructed to circle the score that best applies to their urinary condition during the past week; the overall score the sum of the four scores. Ques-1 How many times do youtypically urinate fromwaking in the morninguntil sleeping at night? Ques 2 How many times do you typically wake up to urinate from sleeping at night until waking in the morning? Ques 3 How often do you have a sudden desire to urinate, which is difficult to defer? Ques 4. How often do you leak urine because you cannot defer the sudden desire to urinate? Total score Sum of 4 question, Maximum score 15. Reduction OABSS will calculated from baseline

  12 weeks

Secondary Outcomes (6)

• Frequency of micturation

  12 weeks

• Urgency

  12 weeks

• Urgency incontinence

  12 weeks

• Nocturia

  12 weeks

• Adverse effects

  12 weeks

Study Arms (2)

Mirabegron

EXPERIMENTAL

Mirabegron 25mg will give daily at night for 12 weeks

Drug: Mirabegron 25mg

Solifenacin

ACTIVE COMPARATOR

Solifenacin Succinate 5mg will give daily at night for 12 weeks

Drug: Solifenacin Succinate 5 MG

Interventions

Mirabegron 25mg DRUG

Mirabegron

Solifenacin Succinate 5 MG DRUG

Solifenacin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female aged ≥18 years
• Patients persistent with OAB symptoms ≥3 months
• The patient able to complete the 3 days voiding diary correctly
• An average of ≥8 micturitions per 24 hours
• An average ≥1 urgency episode per 24 hours
• An average ≥1 nocturia episode per 24 hours

You may not qualify if:

• Clinically significant stress or mixed urinary incontinence.
• Abnormal detrusor activity with known neurological diseases.
• Pregnant and lactating women or those who intended to become pregnant during the study.
• Clinically significant bladder outflow obstruction (PVR \>100ml), symptomatic urinary tract infection, bladder stones, diabetic neuropathy.
• Significant hepatic, renal or other medical diseases.
• Previous pelvic radiation therapy and malignant disease of the pelvic organs.
• Patients with any condition that contraindicate the use of mirabegron or solifenacin medication (urinary retention, uncontrolled narrow angle glaucoma).
• Patient has severe uncontrolled hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mm Hg and/ or average diastolic blood pressure ≥ 110 mm Hg

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1100, Bangladesh

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Final year Resident, Department of urology

Model Details: Randomized Controled clinical trial

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: June 15, 2018
• Study Start: January 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)