NCT00679315已完成2 期
Efficacy and Safety of Alfuzosin for the Treatment of Non-neurogenic Voiding Dysfunction in Female: An 8 Week Prospective, Randomized Double Blind, Placebo-Controlled, Parallel Group Study (Phase Ⅱ)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 9
- 主要终点
- Actual change in the score of IPSS from baseline to 8 weeks of treatment.
研究概览
简要总结
The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in female patients with voiding dysfunction.
详细描述
Trial design
Phase II, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the clinical efficacy and safety of alfuzosin (10mg, qd) from baseline to 8 weeks of treatment in female patients with non-neurogenic voiding dysfunction.
Efficacy Assessment
- Primary efficacy endpoint
Actual change in the score of IPSS from baseline to 8 weeks of treatment. 2. Secondary efficacy endpoint
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged ≥ 18
- •Have voiding symptoms as chief complaints over 3 months
- •IPSS symptom score ≥ 15
- •A peak flow rate <12 mL/sec with a minimum voided volume of 100 mL and/or a postvoid residual urine volume >150 mL
- •Underwent pressure-flow study
排除标准
- •Patients who meet any of the following criteria are to be excluded from the study:
- •Neurogenic voiding dysfunction
- •Anatomic causes of bladder outlet obstruction
- •Perform physical examination in patients diagnosed as BOO in pressure-flow study by urethral evaluation with 16 Fr urethral sound: if there is resistance to 16Fr sound, it will be diagnosed as anatomical BOO and the patients can not participate in the study.
- •Previous surgical procedures related to incontinence or cystocele
- •Pregnant or nursing women
- •Intake of medications and drugs affecting bladder function: alpha blocker, anticholinergic
- •Anticholinergic drugs: Tolterodine, Oxybutynin, Propiverin, Trospium, Solifenacin, SSRI including TCA
- •Cholinergic drug: Bethanechol
- •Any other blocker other than alfuzosin
- •patients can be enrolled after wash-out
- •Any positive urine culture had to be successfully treated before the recruitment.
- •Clinically significant ( ≥ Stamey grade II/III) stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test.
- •Recurrent UTIs defined as having been treated for symptomatic UTIs ≥ 4 times in the last year
- •Diagnosed or suspected interstitial cystitis
- •Patients with marked cystocele or other clinically significant pelvic prolapse.
- •Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with:
- •Estrogen treatment started more than 2 months prior to inclusion will be allowed
- •Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study.
- •Hypersensitive to the study drug
- •Orthotopic hypotension or history of orthotopic hypotension
- •Intake of calcium channel blockers
- •Severe hepatic or renal dysfunctions
研究组 & 干预措施
Alpha blocker
Experimental
alfuzosin hydrochloride XL 10mg
干预措施: alfuzosin hydrochloride XL 10mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Actual change in the score of IPSS from baseline to 8 weeks of treatment.
时间窗: 8 weeks of treatment
次要结局
- IPSS parameters(4 and 8 weeks of treatment.)
- BFLUTS-SF parameters(4 and 8 weeks of treatment)
- Uroflowmetry & PVR parameters(4 and 8 weeks of treatment)
- Micturition diary parameters(4 and 8 weeks of treatment)
- Quality of life parameters(4 and 8 weeks of treatment)
- Patient Perception of Bladder Condition(8 weeks of treatment)
- Benefit, Satisfaction, and Willingness to Continue (BSW) Questions(8 weeks of treatment)
研究者
KYU-SUNG LEE
Professor
Samsung Medical Center
研究点 (9)
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