Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Launched by THE CALIFORNIA MEDICAL INNOVATIONS INSTITUTE, INC. · Mar 29, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Fecobionics in Biofeedback Therapy in Dyssynergia Patients," is looking at a new device designed to help understand and improve how people with a condition called pelvic floor dyssynergia experience bowel movements. Many Americans suffer from constipation, and this study aims to learn more about how the Fecobionics device can monitor and predict how well biofeedback therapy—an approach that helps patients retrain their bowel function—works for those with this condition.

To be eligible for the trial, participants should be between 21 and 75 years old, and they need to have symptoms of obstructed defecation or dyssynergia. It's important that potential participants are not pregnant, have not had certain surgeries, and do not have other specific health issues that could interfere with the study. If you join the trial, you’ll provide consent and undergo some tests to help the researchers gather important information about your condition and treatment. The study is currently recruiting participants, and anyone interested should consider discussing it with their healthcare provider for more details.

Gender

ALL

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.