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

NCT06252714 | Completed FDA Device

• 1 other identifier: 23-090
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Pelvic Organ Prolapse; Rectocele; Bowel Dysfunction

Keywords

defecation posture modification device; defecation posture

Outcome Measures

Primary Outcomes (1)

• Straining with bowel movements

  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.

  2 weeks

Secondary Outcomes (4)

• Colorectal-Anal Distress Inventory 8

  2 weeks

• Consistency of stool

  2 weeks

• Use of laxative medication

  2 weeks

• Ease of device use

  2 weeks

Study Arms (1)

Defecation Posture Modification Device

EXPERIMENTAL

Patients will be given a Squatty Potty Device

Device: Defecation Posture Modification Device

Interventions

Defecation Posture Modification Device DEVICE

Patients will be asked to use the defecation posture modification device with each bowel movement for two weeks.

Also known as: Squatty potty

Defecation Posture Modification Device

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (3)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Rectocele; Intestinal Diseases

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)