Systematized Quality Exercise Alternatives for Stress Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in Quality of Life
研究概览
简要总结
This randomized controlled study evaluates the effect of home biofeedback compared to pelvic floor physical therapy for the treatment of stress urinary incontinence. Half of the participants will use a home biofeedback device for 3 months and the other half will attend pelvic floor physical therapy appointments for 3 months.
详细描述
Biofeedback has been shown to be highly effective the treatment of stress urinary incontinence when used in conjunction with pelvic floor physical therapy under the instruction of a healthcare provider. Home biofeedback has not been well studied, even though several FDA cleared devices are on the market and available for patients to purchase. It is unclear if the biofeedback improves women's urinary incontinence, or if the increased contact with a healthcare provider causes the improvement.
Using a home biofeedback device, a woman places the device in her vagina and contracts the muscles of her pelvic floor to improve the strength, which can improve or cure incontinence when performed over time. Typically it takes 3 months for benefit to be seen.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Subjects >18 years of age
- •SUI or Mixed UI with stress predominant symptoms and more bother by the SUI
- •English speaking/reading
- •Own a smartphone that can support phone application and Bluetooth for the biofeedback device
- •Willing to come for 4 PFPT visits over 3 months if randomized
排除标准
- •Prior anti-incontinence surgery
- •Had prior pelvic floor physical therapy for SUI
- •Prolapse of any compartment noted below the hymen
- •Inability to speak/understand English
- •Decline or unable to return for frequent PT visits during study period
- •Unable to be contacted for follow up by telephone
- •Neurologic disorders known to cause neurogenic bladder
结局指标
主要结局
Change in Quality of Life
时间窗: 3 months
Scale is International Consultation Incontinence Questionnaire short form (ICIQ-SF). Minimum is 0 and Maximum is 21. A higher score indicates greater impairment from incontinence.
次要结局
- Sexual Function(3 Months)
研究者
Gena Dunivan
Associate Professor
University of New Mexico