Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 278
- 主要终点
- Overactive Bladder Validated 8-question
研究概览
简要总结
This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.
详细描述
The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females complaining of lower urinary tract symptoms
- •IPSS ≥ 8 or OAB - V8 score ≥ 8
排除标准
- •Patients with documented hypersensitivity to Silodosin.
- •Patients receiving alpha blockers or anticholinergic medications for any other reason.
- •Patients with history of orthostatic hypotension.
- •Pregnant or breastfeeding females.
- •Patients with stress urinary incontinence.
- •Patients with active urinary tract infection.
- •History of previous pelvic surgery or radiation.
- •Patient with diabetes mellitus.
- •Patients diagnosed with bladder cancer.
- •Patients with hepatic impairment (Child-Pugh score >9).
- •Patients with severe renal impairment with creatinine clearance of less than 10 mL/min.
- •Patients planned to undergo any ophthalmic procedure.
- •Patients with history of urinary retention or gastric retention.
研究组 & 干预措施
Silodosin
Patients will receive 8 mg of Silodosin tablet once daily.
干预措施: Silodosin (Drug)
Placebo
Patients will receive placebo pill once daily,
干预措施: Placebo (Drug)
结局指标
主要结局
Overactive Bladder Validated 8-question
时间窗: 8 weeks
Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome.
International Prostate Symptom Score
时间窗: 8 weeks
International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome.
次要结局
- Uroflometry(8 weeks)
- Adverse events(8 weeks)