Last updated: January 28, 2026
Sponsor: TriHealth Inc.
Overall Status: Completed
Phase
N/A
Condition
Constipation
Genitourinary Prolapse
Gastrointestinal Diseases And Disorders
Treatment
Defecation Posture Modification Device
Clinical Study ID
NCT06252714
23-090
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with pelvic organ prolapse, including a rectocele (posterior compartmentmeasurements to Stage 2 or greater) that endorse bowel dysfunction, based on ouroffice standard screening questionnaires
Exclusion
Exclusion Criteria:
- Anyone currently using a defecation posture modification device Unwillingness orunable to participate in the study Planned travel, inability to use device duringthe study period Patient preparing to undergo pelvic reconstructive surgery prior tothe end of the study period Presence of ileostomy/colostomy Bowel disease such asCrohn's disease or Ulcerative Colitis Daily opiate use Wheelchair bound If devicemay pose fall or safety hazard risk to patient, such as need for walker or cane forambulation.
Patients weighing over 250 lbs, per manufacturer guidelines for the device Inability to understand English Pregnant women
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Defecation Posture Modification Device
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
October 01, 2025
Connect with a study center
Bethesda North Hospital
Cincinnati 4508722, Ohio 5165418 45242
United StatesSite Not Available
Cincinnati Urogynecology Associates
Cincinnati 4508722, Ohio 5165418 45220
United StatesSite Not Available
Good Samaritan Hospital
Cincinnati 4508722, Ohio 5165418 45220
United StatesSite Not Available

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