Impact of Defecation Posture on Ease of Bowel Movements in Patients With a Rectocele
Launched by TRIHEALTH INC. · Feb 2, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether the way people sit on the toilet can help improve bowel movements for women who have a condition called rectocele, which is a type of pelvic organ prolapse. The study will use a special device designed to help change defecation posture, with the goal of making it easier for participants to have bowel movements. Researchers are currently recruiting women aged 65 to 74 who experience bowel difficulties related to their rectocele.
To be eligible for this study, participants must have been diagnosed with a rectocele that is Stage 2 or higher and report issues with bowel function. However, those who are already using a similar device or have certain medical conditions, like inflammatory bowel disease, won't be able to join. If you participate, you can expect to use the device during the study period and share your experiences, which will help researchers understand if this new approach can benefit others in similar situations.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • Anyone currently using a defecation posture modification device Unwillingness or unable to participate in the study Planned travel, inability to use device during the study period Patient preparing to undergo pelvic reconstructive surgery prior to the end of the study period Presence of ileostomy/colostomy Bowel disease such as Crohn's disease or Ulcerative Colitis Daily opiate use Wheelchair bound If device may pose fall or safety hazard risk to patient, such as need for walker or cane for ambulation.
- • Patients weighing over 250 lbs, per manufacturer guidelines for the device Inability to understand English Pregnant women
About Trihealth Inc.
TriHealth Inc. is a leading integrated healthcare system dedicated to enhancing the health and well-being of the communities it serves. Committed to innovation and excellence in patient care, TriHealth conducts clinical trials to advance medical knowledge and improve treatment options across various health conditions. With a focus on collaboration and research integrity, TriHealth partners with healthcare professionals and institutions to facilitate groundbreaking studies that contribute to evidence-based practices and the development of new therapies. Their comprehensive approach ensures that patient safety and ethical standards remain at the forefront of all clinical research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported