LIBERATE International: Evaluation of the Safety and Efficacy of the Viveve Treatment for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Viveve Inc.
- 入组人数
- 99
- 试验地点
- 6
- 主要终点
- CFB in 1-hour Pad Weight Test
研究概览
简要总结
This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.
详细描述
Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed and dated ICF
- •Pre-menopausal females
- •Documented diagnosis of SUI
排除标准
- •Pregnant or planning to become pregnant within the year
- •Undergone other SUI treatments (excluding Kegels)
结局指标
主要结局
CFB in 1-hour Pad Weight Test
时间窗: 6 months post-treatment
Change from baseline in the 1-hour pad weight test to 6 months post-treatment.
次要结局
- Safety and Adverse Event Reporting(6 months post-treatment)