← Back to Search

Behavioural Intervention

Defecation Posture Device for Rectocele

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
Must not have
Wheelchair bound
Patient preparing to undergo pelvic reconstructive surgery prior to the end of the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I use a wheelchair for mobility.
Select...
I am scheduled for pelvic reconstructive surgery before the study ends.
Select...
I have Crohn's disease or Ulcerative Colitis.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Straining with bowel movements
Secondary study objectives
Colorectal-Anal Distress Inventory 8
Consistency of stool
Ease of device use
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Defecation Posture Modification DeviceExperimental Treatment1 Intervention
Patients will be given a Squatty Potty Device

Find a Location

Who is running the clinical trial?

TriHealth Inc.Lead Sponsor
99 Previous Clinical Trials
53,731 Total Patients Enrolled
~15 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top