A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- KYU-SUNG LEE
- 入组人数
- 307
- 主要终点
- Percentage of patients with "add-on" solifenacin treatment
研究概览
简要总结
The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.
详细描述
This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •IPSS ≥ 12
- •Symptoms of OAB as verified by the V8 (≥8)
- •Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- •Mean urinary frequency ≥8 times/24 hours
- •Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)
排除标准
- •Treatment within the 14 days preceding treatment with any alpha blocker drugs
- •A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
研究组 & 干预措施
1.tamsulosin + solifenacin
干预措施: Solifenacin (Drug)
结局指标
主要结局
Percentage of patients with "add-on" solifenacin treatment
时间窗: Weeks of 12, 24 and 52 of combination therapy
次要结局
- Change from baseline in micturition efficacy parameters(Weeks of 12, 24 and 52 of combination therapy)