NCT01764893终止4 期
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Overactive Bladder Questionnaire, items 1-8 only
研究概览
简要总结
The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •history of overactive bladder
- •history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
- •willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
- •able to swallow and retain oral medication
- •able and willing to participate in the full duration of the study
- •able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
- •OAB-q (items 1-8) score of 30 or higher
排除标准
- •presence of cardiac pacemaker and/or defibrillator
- •history of urinary retention
- •history of gastric retention
- •uncontrolled narrow angle glaucoma
- •any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit
- •abnormal liver function test (greater than 3 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin > 3 times the upper limit of normal
- •history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
- •known hypersensitivity to solifenacin
- •participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or any time during the study period
- •pregnancy or trying to become pregnant
- •breast-feeding
研究组 & 干预措施
PTNS and solifenacin
Active Comparator
PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks
干预措施: PTNS plus solifenacin (Other)
PTNS and placebo
Placebo Comparator
PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Overactive Bladder Questionnaire, items 1-8 only
时间窗: Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.
Overactive Bladder Questionnaire, items 1-8 only
时间窗: Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.
次要结局
- Urgency Perception Scale (questionnaire)(Changes in Urgency Perception from Baseline to 15 weeks.)
- 3-day micturition diary(Change in Bladder diary from Baseline to 15 weeks.)
- 3-day micturition diary(Change in Bladder diary from Baseline to 5 weeks.)
- 3-day micturition diary(Change in Bladder diary from Baseline to 11 weeks.)
- Urgency Perception Scale (questionnaire)(Changes in Urgency Perception from Baseline to 11 weeks.)
研究者
研究点 (1)
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