Study on Improving Fecal Continence Muscles Motor Function
This study is looking into how to improve the strength of muscles that help control bowel movements (continence muscles) in people with fecal incontinence. Researchers believe that by making these muscles work against resistance until they get tired, they can become stronger and reduce incontinence. They are using a special device called the continence muscles resistance device (c-RED), which is a balloon placed inside the anus, to provide this resistance. The study will measure changes in anal and vaginal pressure during exercises, both immediately and after 6 weeks of daily exercise. You can join if you are 18 or older, either a healthy volunteer or someone with weakened anal muscles who can perform the exercises. People with certain neurological or muscle diseases cannot participate. The study aims to enroll 340 participants.
- Study design
- This interventional study plans to enroll 340 participants. It will use a device to provide resistance during muscle exercises.
- What's involved
- Participants will use the c-RED device to perform daily exercises for 6 weeks. Anal and vaginal pressure will be measured during Kegel-like exercises at the start and after 6 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured after 6 weeks of exercise.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Mechanisms of Improving Fecal Continence Muscles Motor Function
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- anal pressureduring kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral
- anal pressureafter 6 weeks' exercise, during kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral
- Vaginal pressureduring kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral
- Vaginal pressureafter 6 weeks' exercise, during kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral
- Fecal Incontinence severitybefore and after 6 weeks' exercise
Vaizey Incontinence Score to quantify the severity of fecal incontinence. The Vaizey score is a validated tool and consists of two scoring systems with a five-point scale, which evaluates type and frequency of solid/liquid stool loss, flatus incontinence and impact on quality of life. Vaizey score ranges from 0 to 24, with 0 indicating perfect continent and 24 suggesting complete incontinence.
- Quality of life measurebefore and after 6 weeks' exercise
The investigators will use Fecal Incontinence Quality of Life scale (FIQOL).FIQOL is used to evaluate psychometric health-related quality of life parameters in fecal incontinence patients. The score is arranged on four psychosocial scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment, and contains a total of 29 different items. Subscale scores range from 1 to 5 and are the average response to all items on the scale.