NCT00699049已完成4 期
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KYU-SUNG LEE
- 入组人数
- 94
- 主要终点
- Achievement level of patients' individual satisfaction
研究概览
简要总结
The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- •symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
- •symptoms of urinary frequency ( >8 micturitions per 24 hours)
- •On a stable dose of tamsulosin for at least 1 month
排除标准
- •Previous history of acute urinary retention
- •Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
- •Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- •Symptomatic acute urinary tract infection (UTI) during the screening period
- •Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
- •A 5-alpha reductase inhibitor if started less than 3 months prior to screening
- •Patients with previous urethral, prostate or bladder neck surgery
研究组 & 干预措施
Alpha blocker and placebo
Placebo Comparator
干预措施: Alpha blocker (Drug)
Alpha blocker and placebo
Placebo Comparator
干预措施: placebo (Drug)
Alpha blocker and solifenacin
Experimental
干预措施: Alpha blocker (Drug)
Alpha blocker and solifenacin
Experimental
干预措施: solifenacin (Drug)
结局指标
主要结局
Achievement level of patients' individual satisfaction
时间窗: At weeks 4 and 12
次要结局
- Changes in QoL score by OAB-q(At weeks 4 and 12)
- Changes in urgency episodes(At weeks 4 and 12)
- Changes in OAB symptom scores(At weeks 4 and 12)
研究者
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