The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training : Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The satisfication of pelvic muscle training (PISQ-IR)
研究概览
简要总结
When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.
详细描述
The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18-year-old, non-pregnancy, SUI, bladder capacity > 300ml, RU<150ml, pelvic organ prolapse
排除标准
- •recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems
结局指标
主要结局
The satisfication of pelvic muscle training (PISQ-IR)
时间窗: up to 2 years
The PISQ-IR is a validated questionnaire in research for assessment of female sexual function. A higher score indicates a greater negative impact on sexual function.
The satisfication of pelvic muscle training (ICIQ-SF)
时间窗: up to 2 years
The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (IIQ-7)
时间窗: up to 2 years
The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (UDI-6)
时间窗: up to 2 years
The total score ranges from 0 to 18, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (POPDI-6)
时间窗: up to 2 years
POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms
次要结局
未报告次要终点