Fecobionics in Biofeedback Therapy in Dyssynergia Patients
Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
The California Medical Innovations Institute, Inc.
24 participants
Oct 3, 2023
INTERVENTIONAL
Conditions
Summary
Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.
Eligibility
Inclusion Criteria3
- Subject must provide written informed consent.
- Age between 21-75 years.
- Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
Exclusion Criteria7
- Female who is pregnant or lactating.
- Prior abdominal or anorectal surgery or bowel resection.
- Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
- Confirmed or suspected COVID-19 infection.
- Severe cardiovascular disease.
- Subjects not willing to consent and undergo the specified tests in this study.
- Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.
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Interventions
Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement.
Locations(2)
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NCT05807321