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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Bowel Dysfunction; Rectocele
• Intervention / Treatment: Device: Defecation Posture Modification Device

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Defecation Posture Modification Device; Patients will be given a Squatty Potty Device	Device: Defecation Posture Modification Device; Patients will be asked to use the defecation posture modification device with each bowel movement for two weeks.; Other Names: Squatty potty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of laxative medication	patients will log any laxative medication used	2 weeks
Colorectal-Anal Distress Inventory 8	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.	2 weeks
Consistency of stool	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.	2 weeks
Ease of device use	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.	2 weeks

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: defecation posture modification device; defecation posture
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Hernia; Prolapse; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Pelvic Organ Prolapse; Rectocele
• Other Study ID Numbers: 23-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes