Efficacy and Safety of Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Overactive symptom score (OABSS)
研究概览
简要总结
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
详细描述
Introduction:
Overactive bladder syndrome (OAB) is defined by the International Continence Society as urinary urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia in the absence of proven infection or any other pathology.
Epidemiological data suggest that OAB syndrome is present in about 10.7% of all adult men and women, although prevalence rates increase with aging in both sexes. The prevalence of OAB worldwide is estimated as being greater in women versus men (11.6% vs 9.7%, respectively) It is a chronic symptom complex that can substantially impair quality of life. The prevalence of lower urinary tract symptom (LUTS), OAB and urgency urinary incontinence is substantial, affecting both women and men, and resulting in considerable morbidity, personal cost and health economic burden.
Initial management uses conservative measures, such as fluid advice and bladder training.
Antimuscarinic drugs (eg. Solifenacin succinate) are still the mainstay of oral pharmacological treatment for OAB, relaxing the detrusor muscle and reducing sensory symptoms during the storage phase of the micturition cycle by inhibiting muscarinic receptor subtypes, M2 and M3. Both subtypes are expressed in multiple tissues, increasing the risk of bothersome, anticholinergic adverse events (AEs) such as dry mouth, which along with lack of efficacy, is the most frequently cited reason for discontinuation of antimuscarinic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mirabegron
Mirabegron 25mg will give daily at night for 12 weeks
干预措施: Mirabegron 25mg (Drug)
Solifenacin
Solifenacin Succinate 5mg will give daily at night for 12 weeks
干预措施: Solifenacin Succinate 5 MG (Drug)
结局指标
主要结局
Overactive symptom score (OABSS)
时间窗: 12 weeks
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
次要结局
- Frequency of micturation(12 weeks)
- Urgency(12 weeks)
- Urgency incontinence(12 weeks)
- Nocturia(12 weeks)
- Adverse effects(12 weeks)
- Discontinue drug due to adverse effect(12 weeks)
研究者
Dr. A S M Kutub Uddin Awal
Final year Resident, Department of urology
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh