Impact of Defecation Posture on Ease of Bowel Movements in Patients With a Rectocele

Not Applicable

Recruiting

• Conditions: Pelvic Organ Prolapse; Bowel Dysfunction; Rectocele
• Interventions: Device: Defecation Posture Modification Device

• Registration Number: NCT06252714
• Lead Sponsor: TriHealth Inc.

Brief Summary

The study aims to determine if defecation posture, when using a defecation posture modification device (DPMD), will improve ease of bowel movements in patients with pelvic organ prolapse, specifically rectoceles.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Study Start: 2024-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-09-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Defecation Posture Modification Device	Defecation Posture Modification Device	Patients will be given a Squatty Potty Device

Primary Outcome Measures

Name	Time	Method
Straining with bowel movements	2 weeks	Patients will assess straining with bowel movement on a 0 -10 numeric scale. The scale is called straining or ease with bowel movements. The number 0 indicates no straining and the number 10 indicates maximal straining with bowel movement.

Secondary Outcome Measures

Name	Time	Method
Colorectal-Anal Distress Inventory 8	2 weeks	validated questionnaire to assess bowel function. The colorectal-anal distress inventory 8 is a validated questionnaire that asks 8 questions regarding bowel movements. The question is a YES or NO question. If they respond with YES, they respond with how bothersome they symptoms are. The scale is 1-4 with the number 1 being not at all bothersome and the number 4 being quite a bit bothersome.
Consistency of stool	2 weeks	Bristol stool scale will be used to describe stool consistency. The Bristol stool scale is rated on Type 1- Type 7 describing the consistency of stool. Type 1 is hard lumps ranging to Type 7 which describes entirely watery and liquid stool. The patient is provided with a visual scale to help assist in answering the questions.
Use of laxative medication	2 weeks	patients will log any laxative medication used
Ease of device use	2 weeks	patients will be asked questions regarding satisfaction with and ease of use of device. When asked regarding satisfaction of the device they are asked on an 11 point numeric scale with 0 being not satisfied and 10 being very satisfied.

Trial Locations

Locations (3)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States