Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Changes in the Mean BCI for Male From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
详细描述
The main purpose of this study is to assess the efficacy of TAC-302 for 12 weeks in detrusor underactivity patients with overactive bladder by measuring the following parameters of pressure-flow study.
- Male; bladder contractility index (BCI)
- Female; projected isovolumetric pressure (PIP) 1
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry
- •To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day.
- •To meet the detrusor underactivity criteria by urodynamic study
排除标准
- •Neurogenic bladder by the central nervous system diseases.
- •StageIII or more cystocele of pelvic organ prolapse quantification system (women)
- •Prostate volume ≥30mL (Men)
- •Any symptoms of Urinary tract infection (UTI)
研究组 & 干预措施
TAC-302
干预措施: TAC-302 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the Mean BCI for Male From Baseline to Week 12
时间窗: Baseline to Week 12
BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 150, normal 100-150, and weak \< 100. No theoretical minimum and maximum value of the scale range exists.
Changes in the Mean PIP1 for Female From Baseline to Week 12
时间窗: Baseline to Week 12
PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 75, normal 30-75, and weak \< 30. No theoretical minimum and maximum value of the scale range exists.
次要结局
- Changes in the Mean BVE From Baseline to Week 12 (Overall)(Baseline to Week 12)
- Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)(Baseline to Week 12)
- Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline)(Baseline to Week 12)
- Number of Micturitions Per 24 Hours at Baseline and Week 12(Baseline to Week 12)
- Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12(Baseline to Week 12)
- Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12(Baseline to Week 12)
- Number of Participants With Adverse Events(Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period))
- Number of Participants With Adverse Drug Reactions(Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period))
- Number of Participants With Serious Adverse Events(Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period))
- Number of Participants With Adverse Events Leading to Death(Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period))
- Number of Participants With Adverse Events Leading to Dose Discontinuation(Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period))
- Number of Participants With Adverse Events Leading to Dose Interruption(Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period))