Antimuscarinics as the First-line Treatment for Male With International Prostate Symptom Score (IPSS) Voiding-to-storage Subscore Rati (IPSS-V/S)≤1-- A Prospective Randomized Study Comparing With α-blockers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- The Global Response Assessment (GRA) After the Treatment Day
研究概览
简要总结
This study is a prospective randomized, open label, controlled, double arm, post-marketing study to compare the treatment efficacy of first-line antimuscarinics and α-blockers monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS) (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio (IPSS-V/S) ≤1.
详细描述
- STUDY PROCEDURE
1.1.General Study Design This study is a prospective randomized, open label, controlled, double arm, post-marketing study to compare the treatment efficacy of first-line antimuscarinics and α-blockers monotherapy for men with moderate to severe LUTS (IPSS-T ≥8) and IPSS-V/S ≤1.
1.2. Study Visits and Evaluations
1.2.1 Screening Visit (Baseline, 1 day to 1 week of the first treatment day).
1.2.1.1 Explain the nature of the study and have patients to read and sign an Informed Consent Form.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged ≥40 years with lower urinary tract symptoms (IPSS ≥8)
- •Patient or his/her legally acceptable representative has signed the written informed consent form
排除标准
- •Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- •Patients with urinary retention, urodynamically proven detrusor underactivity or PVR ≥250 mL
- •Patients with known active urinary tract infection, urinary stone or malignancy
- •Patients with history of urethral injury or transurethral surgery for prostate or bladder
- •Patients have laboratory abnormalities at screening including:
- •Aspartate aminotransferase (AST) >3 x upper limit of normal range
- •Alanine aminotransferase (ALT) >3 x upper limit of normal range
- •Patients have abnormal serum creatinine level >2 x upper limit of normal range
- •Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial
- •Patients participated investigational drug trial within 1 month before entering this study
- •Patients with major psychiatric illness or drug abuse
- •Patients taken medication such as alpha-blocker, antimuscarinic or 5 alpha-reductase (5AR) inhibitor within 6 months
研究组 & 干预措施
Group 1
Antimuscarinics (Detrusitol 4 mg QD)
干预措施: Detrusitol 4 mg QD (Drug)
Group 2
α-blockers (Doxazosin 4 mg QD)
干预措施: Doxazosin 4 mg QD (Drug)
结局指标
主要结局
The Global Response Assessment (GRA) After the Treatment Day
时间窗: 1 month after initial treatment
Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month. The global response assessment on a 6-point scale ranging from 1 "No problems at all" to 6 "Many severe problems". Changes of the global response assessment (GRA) improved or reduction by 1 points. Change = Baseline minus Month 1 value Safety: Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
次要结局
- The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day(Baseline and 1 month)
- The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day(Baseline and 1 month)
- The Maximum Flow Rate (Qmax) After the Treatment Day(Baseline and 1 month)
- The Voided Volume After the Treatment Day(Baseline and 1 month)
- The Postvoid Residual Volume (PVR) After the Treatment Day(Baseline and 1 month)
- The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day(Baseline and 1 month)
- The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day(Baseline and 1 month)
研究者
Hann-Chorng Kuo
Department of Urology
Buddhist Tzu Chi General Hospital