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Behavioural Intervention

Posture Device for Easier Bowel Movements After Pelvic Surgery

N/A
Recruiting
Research Sponsored by TriHealth Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing surgery by one of the sub investigators including a posterior compartment repair
Be older than 18 years old
Must not have
Device may pose fall or safety hazard risk to patient
Presence of ileostomy/colostomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will see if using a device to change how you sit on the toilet can make it easier to have your first bowel movement after pelvic surgery.

Who is the study for?
This trial is for individuals who have recently undergone pelvic reconstructive surgery, specifically posterior repair, and are experiencing difficulty with their first bowel movement post-surgery.
What is being tested?
The study is testing whether a defecation posture modification device (DPMD) can make it easier for patients to have their first bowel movement after pelvic organ prolapse surgery.
What are the potential side effects?
Since the intervention involves a non-invasive device to aid in defecation posture, side effects may be minimal but could include discomfort or muscle strain from using the new posture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery with a focus on the back part of my pelvic area by one of the study's doctors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
The device could be a fall or safety risk for me.
Select...
I have an ileostomy or colostomy.
Select...
I use a wheelchair for mobility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month 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 first postoperative bowel movement
Secondary study objectives
Postoperative use of laxatives and pain medication
Satisfaction with device and ease of use
Time to first bowel movement
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Defecation Posture Modification DeviceExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

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Who is running the clinical trial?

TriHealth Inc.Lead Sponsor
99 Previous Clinical Trials
53,663 Total Patients Enrolled
~27 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
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