Phase 2B Study of Rectal Ballooning Training in Female Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Pelvic floor muscle strength
研究概览
简要总结
Urinary incontinence (UI) is a common and worldwide problem.Although pelvic floor muscle training(PFMT) is the standard recommendation for conservative treatment but some patients had difficulty doing PFMT. They could not locate the pelvic floor muscles, and so could not perform the PFMT properly or increase intensity of the exercise. The authors hypothesized that rectal balloon training(RBT) may improve patients' pelvic floor recognition as well as it is another option of progressive strengthening of pelvic floor muscle. This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters
详细描述
This study's aim is to combine RBT with PFMT using the water-filled balloons of Foley catheters. The catheter would be inserted into the rectum and used as a tool to help the patient recognize the pelvic floor muscles. The advantages of Foley catheters are that they are cheap, safe for contacting the mucosa, easy for self-insertion, and can be reused. Furthermore, we can increase the load of exercise by increasing the amount of water pushing into the balloon, and can use that as a tool for progressive resistive exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 25 - 70 years
- •Have urinary incontinence problem
- •Follow command
- •Informed consent
排除标准
- •Previous surgical correction of UI
- •Use medications for treating overactive bladder symptoms
- •Impaired recent and/or recall memory
- •Brain and/or Spinal cord lesion
- •Untreated Urinary tract infection
- •Anal lesion which contradicted for inserting instrument
- •Prolapsed rectum
- •Prolapsed uterus
- •History of pelvic injury
- •Pregnancy
结局指标
主要结局
Pelvic floor muscle strength
时间窗: Change from baseline in pelvic floor muscle strength at 6 weeks
Pelvic floor muscle strength will be assessed by biofeedback and recorded in unit of mmHg.
次要结局
- Clinical symptoms(At the first time then 6 weeks later)
研究者
Natthiya Tantisiriwat, MD
Assist (hon)
Chulalongkorn University