跳至主要内容
临床试验/NCT03252951
NCT03252951已完成不适用

An Innovative Rehabilitation Approach for Women With Anal Incontinence

San Diego State University2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
Change in Length Tension Manometry after 12 weeks

研究概览

简要总结

Anal incontinence is a significant public health problem estimated to affect 7-15% of women in the United States. Traditional rehabilitation strategies include biofeedback and Kegel exercises for pelvic floor muscle strengthening, but this strategy does not incorporate strategies for resistance training that are known to cause muscle strengthening and hypertrophy in other muscles in the body. This study aims to investigate whether a novel pelvic floor resistance exercise program will increase pelvic floor muscle strength and improve anal incontinence and has the potential to impact rehabilitation strategies for the millions of women affected anal incontinence.

详细描述

The current proposal is focused on examining whether a novel resistance exercise program for the pelvic floor will strengthen pelvic floor muscles and improve symptoms in women with anal incontinence. Anal incontinence is a significant public health issue that is estimated to impact 7-15% of women. Traditional rehabilitation strategies such as Kegel exercises and biofeedback are a noninvasive strategy designed to strengthen the pelvic floor muscles, however, these exercises are performed with no resistance. There is a large body of evidence indicating that for muscle strengthening and hypertrophy to occur, exercises must be performed against resistance. Therefore, we have designed a novel exercise program for the pelvic floor that incorporates principals of resistance training known to be effective in other muscles in the body. The long-term goal of this research is to determine the most appropriate noninvasive strategies and interventions to improve pelvic floor function and symptoms of anal incontinence. This project is the first step in achieving this goal. The overall purpose of the current proposal is to determine whether novel physical therapy interventions are more effective than traditional biofeedback strategies in the treatment of anal incontinence. The specific aims of the proposal are: (1) To describe the use of the Functional Lumen Imaging Probe (FLIP) for pelvic floor exercise; (2) To determine whether eccentric, concentric, or isometric exercise training of the pelvic floor has a positive impact on the pelvic floor muscles and on symptoms of anal incontinence compared to traditional biofeedback training; (3) To determine whether using the FLIP in the vagina is as effective as its use in the anal canal for treatment of anal incontinence. To test these aims, the approach includes a randomized controlled exercise trial with use of validated measures of muscle function, muscle hypertrophy and validated symptom measures. This proposal describes an innovative approach to rehabilitation of the pelvic floor muscles that will provide information about pelvic floor function and that has the potential to shift the treatment paradigm for women with pelvic floor disorders.

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
Single (Outcomes Assessor)

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • AI based on FISI questionnaire
  • FISI scores between 10 and 45
  • able to voluntarily contract pelvic floor muscles based on manometry measures

排除标准

  • FISI score below 10 (mild disease) or greater than 45 (severe disease)
  • manometry measure below the 10th percentile of normal (lack of muscle) or above 70th percentile of normal (little room to improve strength)
  • history of large external hemorrhoids or history of bleeding hemorrhoids; co-existing inflammatory bowel disease
  • constipation that is directly linked to neurological conditions such as spinal and peripheral nerve pathologies
  • large pelvic organ prolapse (greater than stage 3)
  • inability to contract the pelvic floor muscles on command
  • pregnancy

结局指标

主要结局

Change in Length Tension Manometry after 12 weeks

时间窗: 12 weeks

change from baseline to 12 weeks

次要结局

  • Change in Muscle Hypertrophy (Ultrasound) after 12 weeks(12 weeks)
  • Change in FISI score after 12 weeks(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Tuttle

Associate Professor

San Diego State University

研究点 (2)

Loading locations...

相似试验