Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Description

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.

Conditions

Dyssynergia, Constipation

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Study Overview

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Study Details

Study overview

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.

Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Condition
Dyssynergia
Intervention / Treatment

-

Contacts and Locations

San Diego

California Medical Innovations Institute, San Diego, California, United States, 92121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

21 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The California Medical Innovations Institute, Inc.,

Study Record Dates

2025-03-31