Fecobionics in Biofeedback Therapy in Dyssynergia Patients
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
- Fecobionics (device)
Sponsor: The California Medical Innovations Institute, Inc. · Participants: 24 · Started: Oct 3, 2023
Contact the study team
- Hans Gregersen, PhD · Phone: 858-249-7400
- Satish Rao, MD, PhD · Phone: 706-7212238
Official record on ClinicalTrials.gov — NCT05807321
Locations in the U.S.
| California | California Medical Innovations Institute, San Diego |
| Georgia | Digestive 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.