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Behavioural Intervention

Defecation Posture Modification Device for Pelvic Organ Prolapse 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

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

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

Primary outcome measures

Straining with first postoperative bowel movement

Secondary outcome measures

Postoperative use of laxatives and pain medication

Satisfaction with device and ease of use

Time to first bowel movement

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Defecation Posture Modification DeviceExperimental Treatment1 Intervention

Group II: ControlActive Control1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

TriHealth Inc.Lead Sponsor

97 Previous Clinical Trials

53,428 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 process currently in progress for participants of this research study?

"The trial, as indicated on clinicaltrials.gov, is not in the recruitment phase. The trial was first listed on March 1st, 2024 and last altered on February 2nd, 2024. While this specific study is no longer accepting participants, there are currently 152 other trials open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair

2024. "Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253689.

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