NCT06253689

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

February 2, 2024

Last Update Submit

April 16, 2025

Conditions

Postoperative ConstipationPelvic Organ Prolapse Vaginal SurgeryDefecation Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • postoperative stool consistency

    1 week

  • Time to first bowel movement

    1 week

  • pain with postoperative bowel movements

    1 week

  • Postoperative use of laxatives and pain medication

    1 week

  • Satisfaction with device and ease of use

    1 month

Study Arms (2)

Defecation Posture Modification Device

EXPERIMENTAL
Device: Defecation Posture Modification Device

Control

NO INTERVENTION

Interventions

Defecation Posture Modification DeviceDEVICE

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.

Also known as: Squatty potty
Defecation Posture Modification Device

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery by one of the sub investigators including a posterior compartment repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 12, 2024

Study Start

February 19, 2024

Primary Completion

February 15, 2025

Study Completion

March 21, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)