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临床试验/NCT07709078
NCT07709078进行中(未招募)不适用

FASED: Footstool in Alleviating Symptoms of Evacuation Disorder

Ohio State University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
Complete Spontaneous Bowel Movements

研究概览

简要总结

The purpose of this research study is to compare the use of footstools of 2 different heights in patients with symptoms of pelvic floor dysfunction such as straining excessively during bowel movements and a sense of incomplete emptying. We are testing these footstools to see if using a footstool can improve these symptoms. Participants who enroll will be randomly assigned to either a 7 or 9 inch footstool. They will use the footstool for 8 weeks. During this time they will complete some online surveys about their bowel symptoms.

详细描述

Pelvic floor dysfunction is a very common problem. The prevalence of this problem is estimated to be about 16 per 100,000 person years. In one study, 52% of patients with delayed gastric emptying and symptoms of nausea and vomiting had an evacuation disorder. In this condition, there is either impaired relaxation of the pelvic floor muscles or weakness of the pelvic floor muscles. This combined usually with impaired ability to sense presence of and quantity of stool and gas in the rectum leads to difficulty evacuating stool and gas. Characteristically, these patients have difficulty emptying stool even when its soft and pasty. Some of them can only feel empty when their stools are watery. However, diarrhea comes with its inherent risks of accidental bowel leakage.

The management of pelvic floor disorders is primarily pelvic floor biofeedback therapy. The purpose is to correct the abnormal physiology to help improve emptying. Additional therapies include use of stimulant suppositories and enemas and use of foot stool. The premise behind use of a foot stool is that is helps relax the pelvic floor muscle. While there are several companies making footstools, there is surprisingly very sparse literature supporting their use.

The purpose of this research study is to investigate whether using a footstool could improve bowel symptoms in patients who experience symptoms of pelvic floor dysfunction. Participants who are eligible and enroll will complete a 2 week baseline bowel diary followed by an 8 week period during which they will be asked to use a footstool provided to them. They will be randomly assigned either to a 7 or a 9 inch footstool. During this period they will also complete surveys about their bowel symptoms.

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
All
接受健康志愿者

入选标准

  • Age 18 years or older Able to understand, read, and write English
  • Evidence of pelvic floor dysfunction based on at least one of the following:
  • Symptoms of excessive straining during bowel movements, feeling of incomplete evacuation, or need for digital evacuation of stool more than 25% of the time Abnormal anorectal manometry Abnormal balloon expulsion test Abnormal magnetic resonance imaging (MRI) defecography or barium defecography

排除标准

  • Any physical, mental, or emotional condition that, in the opinion of the Principal Investigator, may pose a safety concern or interfere with study participation Prior use of a toilet footstool for defecation Currently pregnant, based on self-reported pregnancy status during screening Active cancer Current opioid use

研究组 & 干预措施

7 Inch footstool

Active Comparator

Participants in this group receive a 7 inch footstool

干预措施: 7 inch Footstool for bowel movements (Device)

9 inch footstool

Active Comparator

Participants in this group receive a 9 inch footstool

干预措施: 9 inch Footstool for bowel movements (Device)

结局指标

主要结局

Complete Spontaneous Bowel Movements

时间窗: 8 weeks

We will calculate the change in number of complete spontaneous bowel movements (CSBMs) after 8 weeks of footstool use compared to that during the 2 week baseline period.

Change in Average Weekly Complete Spontaneous Bowel Movements (CSBMs)

时间窗: 8 weeks

The change in average weekly number of complete spontaneous bowel movements (CSBMs) from baseline to Week 8 will be compared between participants randomized to the 7-inch footstool and participants randomized to the 9-inch footstool. A CSBM is defined as a spontaneous bowel movement associated with a self-reported sense of complete bowel evacuation, as recorded in the daily bowel diary. Baseline values will be calculated from the 2-week pre-intervention period.

次要结局

  • Change in IBS Symptom Severity(8 weeks)
  • Change in Irritable Bowel Syndrome Symptom Severity Score(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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