Comparison of the Viveve Treatment and Cryogen-Only Treatment Versus Sham 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
- 38
- 试验地点
- 3
- 主要终点
- 1-hour Pad Weight Test
研究概览
简要总结
This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.
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
- Single (Participant)
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
- •Pre-menopausal females, ≥ 18 years of age. Premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months.
- •Subjects with a BMI of ≤ 35 kg/m².
- •1-hr pad weight at Baseline with a 5 to 50 g net increase from the pre-test pad weight
排除标准
- •Subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
- •Subjects who are pregnant or plan to become pregnant during the course of the study.
- •Subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., Kegel exercises).
- •Has any implantable electrical device [e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)].
- •Subjects who have started or changed dose of local vaginal hormones <6 weeks before Screening.
- •Subjects who have started pelvic floor physical therapy within the last 3 months.
- •Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including the Viveve Treatment or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure, and previous dilation and cuterage within 12 months of the subject's Pre-Screening Visit).
结局指标
主要结局
1-hour Pad Weight Test
时间窗: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
Brief description of test: * Subject puts on one standardized, pre-weighed pad without voiding. * Subject drinks 500 mL of sodium-free liquid in \< 15 min while sitting or resting. • 15 - 45 Minutes: * Subject walks for 30 minutes, including climbing one flight of stairs (up and down). • 45 - 60 Minutes: * Subject performs the following activities Standing up from sitting (10 times) Coughing vigorously (10 times) (Subject should be standing) Running on the spot (1 min) Bending to pick up an object from the floor (5 times) • The weight of the pad is measured to determine the amount of leakage.
次要结局
未报告次要终点