Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Pelvic floor muscle strength assessed by palpation
研究概览
简要总结
The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery.
The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.
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
- 否
入选标准
- •referred to surgery for urogenital prolapse
- •informed consent
排除标准
- •not able to communicate in Norwegian or English
- •not able or willing to sign informed consent
结局指标
主要结局
Pelvic floor muscle strength assessed by palpation
时间窗: 9 months
Muscle strength is evaluated using 6 point modified Oxford Scale (MOS) range 0-5.
Pelvic floor muscle strength assessed by ultrasound
时间窗: 9 months
Changes in pelvic floor muscle at rest and during pelvic floor contraction, measured in mm and calculated proportional change
Symptoms of pelvic floor disorders
时间窗: 9 months
Symptoms of pelvic floor disorders assessed by validated questionnaire (PDFI-20)
次要结局
- Proportion of anatomical sphincter ani defect(9 months)
- Imaging of synthetic implants assessed by ultrasound(9 months)
- Pelvic floor muscle strength assessed by electromyography(9 months)
- Assessment of pelvic organ mobility as a measure of pelvic organ function/dysfunction(9 months)
- Pelvic floor muscle strength assessed by perineometry(9 months)
- Proportion of anatomical pelvic organ prolapse(9 months)
- Proportion of levator ani muscle trauma(9 months)
- Symptoms of pelvic floor disorders(9 months)