Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair

This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse Vaginal Surgery; Defecation Function; Postoperative Constipation
• Intervention / Treatment: Device: Defecation Posture Modification Device

• Study Type: Interventional
• Enrollment (Actual): 160
• 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 undergoing surgery by one of the sub investigators including a posterior compartment repair

Exclusion Criteria:

• Anyone currently using a defecation posture modification device
• Unwillingness or unable to participate in the study
• Presence of ileostomy/colostomy
• Wheelchair bound
• Device may pose fall or safety hazard risk to patient
• Patients weighing over 250 lbs, as per device manufacturer guidelines
• Inability to understand English
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Defecation Posture Modification Device	Device: Defecation Posture Modification Device; Patients assigned to the experimental arm will be asked to use the defecation posture modification device to aid with bowel movements during the postoperative period.; Other Names: Squatty potty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Straining with first postoperative bowel movement	patients will keep 7 day log of each postoperative bowel movement within the first week of surgery, they will assess with an 11 point numeric rating scale their level of strain with bowel movement, the scale starts at 0 indicating no straining and 10 indicating maximal straining/effort. I high score of 10 means a worse outcome. The scale title is "straining with bowel movement".	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first bowel movement	7 day log for patients to track bowel movements within 1st week of surgery	1 week
Postoperative use of laxatives and pain medication	patients will keep 7 day log of daily usage of standard postoperative pain medication and laxative use	1 week
postoperative stool consistency	7 day bowel movement diary using bristol stool scale to describe stool consistency. The Bristol Stool scale is a validated scale to describe each type stool consistency. The scale is from Type 1 - Type 7. Type 1 is separate hard lumps of stool and ranges up to Type 7 which is watery and entirely liquid stool. In this scale the two ends (high and low) are concerned worse outcomes, the middle of the scale - Type 4 is the ideal outcome.	1 week
pain with postoperative bowel movements	7 day log where patients input each bowel movement for the first week postoperative, 11 point numeric scale for tracking pain. The scale is a pain rating scale with 0 indicating no pain with bowel movements and 10 indicating worst possible pain with bowel movements. The title of the scale is "Pain with bowel movements". The worse outcome is a 10 and the best outcome is a zero.	1 week
Satisfaction with device and ease of use	patients will receive a questionnaire with questions regarding their satisfaction with the device and ease of use. When asked about satisfaction of the device, patients will be given an 11 point numeric scale assessing satisfaction. The number 0 will indicate not satisfied and 10 will indicate very satisfied with use of the device. The title of the scale is "satisfaction with device". The Best outcome is a 10 and the worst outcome is a 0.	1 month

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): March 21, 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): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Signs and Symptoms, Digestive; Constipation; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 23-087

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