Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Recruiting now · Not applicable

Conditions studied: Dyssynergia, Constipation

In brief

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.

Key facts

Study ID: NCT05807321
Run by: The California Medical Innovations Institute, Inc.
People needed: 24
Starts: 2023-10-03
Expected to finish: 2027-03-31
Last updated by the study team: 2025-10-21

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

California Medical Innovations Institute — San Diego, California, United States (enrolling)
Digestive Health Center- Augusta University — Augusta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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