A Multicentric Randomized Double Blind Active Controlled Prospective Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety and Tolerability of FDC of Tamsulosin Hydrochloride plus Mirabegron Prolonged Release Tablets versus FDC of Silodosin plus Mirabegron ER Film Coated Bilayered Tablets in Adult Patients Diagnosed with Benign Prostatic Hyperplasia Complicated by Overactive Bladder with Symptoms of Urge Urinary Incontinence Urgency and Frequency
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 9
- 主要终点
- Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 8.
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is the most common benign disease in men with various lower urinary tract symptoms (LUTS) and is the fourth most common disease among men aged 50 years and older; the prevalence of BPH in men aged 70 years and older is more than 80%.17 BPH results in LUTS clinically, and symptoms can be classified as storage, voiding, and postmicturition, and often affect patients’ quality of life (QoL). Patients with BPH may have one predominant type of symptom rather than other symptoms, and symptoms often appear in different forms as the disease progresses. According to the EPIC study, the prevalence of storage (men, 51.3%; women, 59.2%), voiding (men, 25.7%; women, 19.5%), and postmicturition LUTS (men, 16.9%; women, 14.2%) are generally similar between men and women, and prevalence increases with age. According to Silva et al.,18 it is difficult to aim for newer effective and well-tolerated selective treatments for BPH/LUTS due to an incomplete understanding of the mechanism of the cause and progression of the disease. Overactive bladder (OAB) is classified as a symptom syndrome presenting with urinary urgency with or without urgency incontinence, and usually with frequency and nocturia. In addition, it worsens patients’ QoL.4 The European Association of Urology offers practical evidence-based guidelines on the assessment and treatment of men aged 40 years and older who present with LUTS.19 They also recommend that medical history, validated symptom score questionnaires, voiding diary, physical examination, including digital rectal examination, urinalysis, prostate-specific antigen (PSA), and frequency volume chart are helpful as an initial assessment of BPH. The International Prostatic Symptom Score (IPSS) is used to assess urinary symptom severity and QoL.20 It is also used to document subjective responses to treatment. Measurement of urinary flow rates and residual urine is helpful in diagnostic evaluation and treatment response. Many male patients with LUTS do not need medical management or surgical intervention, but patients with moderate-to-severe LUTS require medical or surgical treatment. Alpha-1 adrenoceptor blocker (A1B) is the most commonly used pharmacological agent to treat LUTS in men with BPH.21 However, even after treatment with A1B, storage or OAB symptoms may persist. The 2015 European Urologic Association guideline recommends antimuscarinics or beta-3-adrenoceptor agonists (B3A) in men with BPH to treat moderate-to-severe LUTS with predominant bladder storage symptoms, and when both monotherapies are insufficient to relieve symptoms, a combination therapy of A1B and antimuscarinic agents is recommended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male patients aged 45 to 65 years (both inclusive) with confirmed diagnosis of benign prostatic hyperplasia complicated by overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than equal to 8 per day and urinary urgency episodes greater than equal to 1 per day).
- •2.Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •3.Patients willing to comply with the protocol requirements.
排除标准
- •Patients with known or suspected hypersensitivity to investigational products or any other component of the formulation.
- •Patients having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction.
- •Patients having urinary retention requiring catheterization.
- •Patients having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products.
- •Patients taking Botulinum toxin injection for urgency urinary incontinence (UUI) in the last year.
- •Patients current therapy with peripheral or sacral neuromodulation.
- •Patients with neurologic conditions that may affect urinary function like stroke, multiple sclerosis, spinal cord injury, Parkinsons disease.
- •Patients with glycosylated hemoglobin (HbA1c) greater than equal to 07 percent at screening.
- •Patients with significant cardiac disorder (e.g., cardiac valve disease requiring a specific treatment, pericardial constriction, life-threatening arrhythmia, uncontrolled hypertension, acute myocardial infarction, permanent atrial fibrillation).
- •Patients with severe renal insufficiency or ongoing/planned dialysis.
- •Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
- •Patients who are unwilling to use contraception while receiving investigational product.
- •Patients with failure to control systemic fungal, bacterial or viral infection.
- •Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
- •Patients with suspected inability or unwillingness to comply with the study procedures.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 8.
时间窗: 8 weeks
Change in International Prostate Symptom Score (IPSS) from baseline to week 8
时间窗: 8 weeks
次要结局
- Number of Micturition Per 24 Hours a week 2, week 4 and week 8 and compare to baseline (Micturition include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)).(Number of micturition Urgency Episodes per 24 Hours at week 2, week 4 and week 8.)
研究者
Dr Tapan Kumar Mandal
Nil Ratan Sircar Medical College and Hospital