Fecobionics in Biofeedback Therapy for Dyssynergia and Constipation
This study is testing a new device called Fecobionics to better understand and treat constipation caused by dyssynergia (a problem with muscle coordination during bowel movements). The Fecobionics device is inserted into the rectum to collect detailed information about how your body works during defecation. Researchers hope this information will help predict who will benefit most from biofeedback therapy, a treatment for dyssynergia. You may be able to join if you are between 21 and 75 years old, have been diagnosed with obstructed defecation/dyssynergia, and are starting biofeedback therapy at UCSD or Scripps. The study aims to see how long it takes to expel the device and measure pressure differences within it after 1.5 years.
- Study design
- This is an interventional study with a planned enrollment of 24 participants. The study aims to monitor and predict biofeedback therapy outcomes using a new medical device.
- What's involved
- You will have the Fecobionics device inserted into your rectum, and you will be asked to perform actions like coughing, squeezing, or pushing. This will happen before, during, and after biofeedback therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes, expulsion duration and pressure difference, will be measured at 1.5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Fecobionics in Biofeedback Therapy in Dyssynergia Patients
At a glance
Conditions
NCT05807321
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
California Medical Innovations Institute
San Diego, Californiastudy coordinator listed
Recruiting
Digestive Health Center- Augusta University
Augusta, Georgiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Expulsion Duration1.5 year
The time it takes to defecate Fecobionics
- Pressure Difference between front and rear ends of Fecobionics1.5 year
A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases.