NCT02034604已完成4 期
Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Changes in patients' symptom questionnaires
研究概览
简要总结
This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 20 years old and above (upper limit of age: 80 years old)
- •patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
- •IPSS ≥ 12 and QoL ≥ 3
- •Maximum Flow Rate <15 mL/s (Voiding volume) ≥ 120mL)
- •Ability and willingness to correctly complete the micturition diary and questionnaire
- •Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
排除标准
- •In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
- •In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
- •In female, the history of anti-incontinence operation.
- •Patients with cancer of any type including cancer of the prostate or bladder
- •Patients with urethral stricture or bladder neck contracture
研究组 & 干预措施
Naftopidil Group
Experimental
Naftopidil medication patients
干预措施: Naftofidil (Drug)
Tamsulosin Goup
Active Comparator
Tamsulosin medication patients
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Changes in patients' symptom questionnaires
时间窗: from baseline to 8 weeks of treatment
international prostate symptom score (IPSS) change, except QOL domain scores
次要结局
- Score of global response assessment for Korean, GRA-K(8 weeks after treatment)
- Treatment satisfaction question, TSQ(8 weeks after treatment)
- safety evaluation : incidence and severity of adverse events(up to 8 weeks)
- Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.(from baseline to 8 weeks of treatment)
- Benefit, Satisfaction, and Willingness to Continue (BSW) questions(8 weeks after treatment)
- Changes in uroflow parameters(from baseline to 8 weeks of treatment)
- change in number of urinary frequency, nocturia(up to 8weeks)
- change in each domain scores of IPSS(up to 8 weeks)
研究者
KYU-SUNG LEE
professor,MD,PhD
Samsung Medical Center
研究点 (1)
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