Fecobionics for Bowel Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tool called Fecobionics, designed to improve understanding of bowel movements, particularly for those with bowel incontinence. Fecobionics mimics a real stool and measures the response of anal muscles during bowel movements. The goal is to gain insights into bodily functions during defecation and enhance testing methods. Individuals who have experienced bowel incontinence and can undergo the required study tests might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance diagnostic methods for bowel incontinence.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that Fecobionics is safe for bowel incontinence studies?
Research shows that Fecobionics is designed to mimic natural stool during tests that evaluate bowel movement function, aiming to make these tests more realistic. Although specific studies on the safety of Fecobionics are lacking, it is intended to make testing more natural and less intrusive.
Fecobionics is not a new drug or chemical treatment; it functions as a tool to measure bowel function. As a result, it may have fewer side effects compared to medication-based treatments. However, since detailed safety data is unavailable, potential risks are still under investigation.
This trial is labeled as "Not Applicable" for phase, indicating that the safety information might not be as comprehensive as in later-phase trials. Participants should consult their healthcare provider to discuss any concerns and better understand the possible risks and benefits.12345Why are researchers excited about this trial?
Fecobionics is unique because it offers a new approach to managing bowel incontinence by simulating the natural function of the bowels. Unlike traditional treatments like medications or surgical interventions, Fecobionics uses a biofeedback tool (BFT) that provides real-time feedback on bowel function. This innovative method allows both patients and healthcare providers to better understand and potentially improve bowel control. Researchers are excited because this could lead to more personalized and effective management of bowel incontinence, offering hope for patients seeking alternatives to existing treatment options.
What evidence suggests that Fecobionics is effective for bowel incontinence?
Research has shown that Fecobionics can help treat bowel incontinence by mimicking natural stool and providing detailed information about rectal and anal function. In this trial, participants may receive Fecobionics as part of a biofeedback training (BFT) tool, which studies indicate improves symptoms in 65-75% of individuals with bowel incontinence. This method combines several existing tests to provide a comprehensive view of bodily functions during bowel movements. By measuring pressures and changes in the anal canal, Fecobionics offers new insights that could enhance the management of bowel incontinence.16789
Who Is on the Research Team?
Hans Gregersen, MD, PhD
Principal Investigator
California Medical Innovations Institute
Are You a Good Fit for This Trial?
This trial is for individuals aged 18 to 75 who experience bowel incontinence or are healthy volunteers. Participants must be willing and able to complete study procedures and provide consent. It's not suitable for those with chronic constipation, prior bowel resections, anorectal surgery, or pregnant women.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Fecobionics Evaluation
Participants undergo evaluation using the Fecobionics device to measure pressures, cross-sectional area, orientation, and viscoelastic properties of the anorectum.
Biofeedback Training
Participants receive biofeedback training based on Fecobionics data to improve anorectal function.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fecobionics
Fecobionics is already approved in United States, European Union for the following indications:
- Constipation
- Fecal Incontinence
- Constipation
- Fecal Incontinence
Find a Clinic Near You
Who Is Running the Clinical Trial?
The California Medical Innovations Institute, Inc.
Lead Sponsor
Augusta University Medical Center
Collaborator