Effect of changing defecation posture on bowel movements in rectocele patients
Impact of Defecation Posture on Ease of Bowel Movements in Patients With a Rectocele.
This study tests if changing the way people with rectoceles sit on the toilet can help them have easier bowel movements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | TriHealth Inc. Academic / other |
| Locations | 3 sites (Cincinnati, Ohio and 2 other locations) |
| Trial ID | NCT06252714 on ClinicalTrials.gov |
What this trial studies
This study investigates whether using a defecation posture modification device can enhance the ease of bowel movements for patients suffering from rectoceles, a type of pelvic organ prolapse. Participants will be assessed based on their bowel dysfunction and will use the device during the study period to determine its effectiveness. The study aims to provide insights into how posture during defecation can impact bowel health in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with pelvic organ prolapse, specifically rectoceles, who experience bowel dysfunction.
Not a fit: Patients currently using a defecation posture modification device or those with certain bowel diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bowel movement ease and overall quality of life for patients with rectoceles.
How similar studies have performed: While the specific approach of using a defecation posture modification device is novel, similar studies on defecation posture have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cincinnati, Ohio and 2 other locations
- Cincinnati Urogynecology Associates — Cincinnati, Ohio, United States (Recruiting)
- Good Samaritan Hospital — Cincinnati, Ohio, United States (Recruiting)
- Bethesda North Hospital — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Meredith Carrel-Lammert
- Email: meredith_Carrel-lammert@Trihealth.com
- Phone: 513-463-4300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.