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Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Recruiting

Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Who can join

Ages 21 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Subject must provide written informed consent.
2. Age between 21-75 years.
3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.

Exclusion Criteria:

1. Female who is pregnant or lactating.
2. Prior abdominal or anorectal surgery or bowel resection.
3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
4. Confirmed or suspected COVID-19 infection.
5. Severe cardiovascular disease.
6. Subjects not willing to consent and undergo the specified tests in this study.
7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

About the study

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.

What is being tested

Sponsor: The California Medical Innovations Institute, Inc. · Participants: 24 · Started: Oct 3, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05807321

Locations in the U.S.

CaliforniaCalifornia Medical Innovations Institute, San Diego
GeorgiaDigestive Health Center- Augusta University, Augusta

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.