← Back to Search

Behavioural Intervention

Defecation Posture Modification Device for Irritable Bowel Syndrome

N/A

Waitlist Available

Research Sponsored by TriHealth Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with pelvic organ prolapse, including a rectocele (posterior compartment measurements to Stage 2 or greater) that endorse bowel dysfunction, based on our office standard screening questionnaires

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial aims to see if using a device to change how you sit on the toilet can help make it easier for patients with a certain type of pelvic organ prolapse to have bowel movements.

Who is the study for?

This trial is for individuals with pelvic organ prolapse, including a rectocele at Stage 2 or greater, who experience bowel dysfunction. Participants must not be wheelchair-bound, over 250 lbs, using opiates daily, pregnant, planning surgery soon, or have certain bowel diseases like Crohn's.Check my eligibility

What is being tested?

The study tests whether a Defecation Posture Modification Device (DPMD) can make it easier for patients with rectoceles to have bowel movements. It explores the impact of changing how one sits during defecation on easing these movements.See study design

What are the potential side effects?

Since this trial involves a non-invasive device to aid in defecation posture and does not include medication or surgical intervention, side effects are minimal but may include discomfort from using the new device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a pelvic organ prolapse affecting my bowel functions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Straining with bowel movements

Secondary outcome measures

Colorectal-Anal Distress Inventory 8

Consistency of stool

Ease of device use

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Defecation Posture Modification DeviceExperimental Treatment1 Intervention

Patients will be given a Squatty Potty Device

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

TriHealth Inc.Lead Sponsor

97 Previous Clinical Trials

53,528 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of participants still ongoing for this clinical trial?

"As per clinicaltrials.gov, this specific trial is presently not in need of additional participants. Originally shared on March 1st, 2024 and last revised on February 2nd, 2024. Although closed for recruitment, there are currently 201 other trials accepting new enrollees at present."

Answered by AI