Pelvital Stress Urinary Incontinence Training Device: P-SUIT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Improvement in severity of involuntary urine loss
研究概览
简要总结
The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence
详细描述
120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender,
- •Ages 18-75,
- •Clinical diagnosis of stress urinary incontinence,
- •Ability to contract the pelvic floor muscles,
- •Able to document incontinence and voiding in a diary,
- •Provision of written informed consent form,
- •Minimum of 10 grams increase at initial 24-hour pad weight test
排除标准
- •Diagnosed mixed or urge urinary incontinence,
- •Impaired cognitive function or neurologic conditions
- •Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
- •Acute infections or hematuria,
- •Pregnant or actively trying to conceive,
- •History of pelvic irradiation,
- •Concurrent medications with α-adrenergic antagonists or diuretics
- •Pelvic organ prolapse stage III or IV,
- •Severe urethral sphincter weakness and/or defect,
- •Suspected urethral and/or vesical fistula
结局指标
主要结局
Improvement in severity of involuntary urine loss
时间窗: Baseline, 6 weeks
Measured by pad testing
次要结局
- incontinence episode frequency(Baseline, 6 weeks)
- health-related quality of life(Baseline, 6 weeks)