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

NCT ID: NCT06253689

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2025-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Constipation Pelvic Organ Prolapse Vaginal Surgery Defecation Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Defecation Posture Modification Device

Group Type EXPERIMENTAL

Defecation Posture Modification Device

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Squatty potty

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Site Status

Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-087

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.