Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05807321
Study type	Interventional
Source	The California Medical Innovations Institute, Inc.
Contact
Status	Recruiting
Phase	N/A
Start date	August 15, 2023
Completion date	March 31, 2025

View Details

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