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

See also
Status	Clinical Trial	Phase
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Recruiting	`NCT06292949` - Clinical Study of Resistant Starch in Improving Constipation	N/A
Recruiting	`NCT04132661` - MRI Assessment of Mode of Action of Bisacodyl, Single Dose	Phase 4
Completed	`NCT02726295` - The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study	Phase 4
Terminated	`NCT02839889` - Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)	Phase 4
Recruiting	`NCT02255747` - Anal Dilatation for Infants and Children With Constipation	N/A
Completed	`NCT02246647` - Biomarkers for Intestinal Permeability in Patients With Constipation
Completed	`NCT01566409` - Maintenance Treatment for Children With Constipation	N/A
Completed	`NCT02863848` - Effect of Inulin-type Fructans on Constipated Children.	N/A
Completed	`NCT01695915` - Diurnal Variation in Rectal Diameter	N/A
Completed	`NCT01710579` - Normal Values in Ano-rectal 3D High Resolution Manometry	N/A
Completed	`NCT02658201` - Ultrafast MRI Imaging to Exclude Constipation	N/A
Completed	`NCT01438567` - A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy	Phase 3
Completed	`NCT01411501` - Efficacy and Safety of Acupuncture for Functional Constipation	Phase 3
Completed	`NCT01474499` - A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation	Phase 3
Completed	`NCT01170039` - The Effectiveness of Lubiprostone in Constipated Diabetics	Phase 4
Completed	`NCT00931853` - Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).	Phase 3
Active, not recruiting	`NCT02442115` - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Terminated	`NCT01003249` - Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen	Phase 4
Completed	`NCT00994851` - Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.	Phase 3