NCT06532123 · Medical College of Wisconsin
Mechanisms of Improving Fecal Continence Muscles Motor Function
What this study is about
The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.
View original scientific description
The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.
Interventions
DEVICE
continence muscles resistance device
The c-RED consists of a noncompliant cylindrical balloon (intra-anal balloon) that is connected to a small compliant balloon (external balloon) by a 2 mm diameter tube and a stopcock to allow for air to be filled and sealed in the system. The system is prefilled with air to determine the amount of air needed for a given internal pressure, or desired resistance of the intra-anal balloon. This is determined using a sphygmomanometer gauge in a sealed system.
Primary outcome measures
anal pressure
Time frame: during kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral
anal pressure
Time frame: after 6 weeks' exercise, during kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and anal squeeze contractile integral
Vaginal pressure
Time frame: during kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral
Vaginal pressure
Time frame: after 6 weeks' exercise, during kegel like exercise
Maximum squeeze pressure, mean squeeze pressure and vaginal squeeze contractile integral
Fecal Incontinence severity
Time frame: before 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 measure
Time frame: before 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Healthy volunteers without past or present history of fecal incontinence
- Patients age 18 years and older with reduced anal resting and or squeeze pressure, reflecting weakness of the anal sphincters who can perform the study
Exclusion criteria
- Any one less than 18 years old
- Neurological disorders like dementia, cerebrovascular diseases
- Muscle diseases like muscular dystrophy, myopathies
- Inflammatory bowel disease or celiac disease
- Neuro-muscular junction disorders/myasthenia gravis, Eaton-Lambert syndrome
- Organ prolapse, large rectocele(\>2cm), rectal intussusception
- Hip dysplasia or recent hip surgery and immobile patients.
- Patients with complete normal anal resting and squeeze pressure
- Impaired rectal evacuation (dyssynergy defecation)
- Fecal incontinence completely due to loss of rectal sensation
- Subjects unable to contract their external anal sphincter at all
Where
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 23, 2025 · Source of record for eligibility and locations