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

TriHealth

Status: Enrolling

Conditions: Pelvic Organ Prolapse; Rectocele; Bowel Dysfunction

Treatments: Device: Defecation Posture Modification Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06252714

23-090

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Defecation Posture Modification Device

Experimental group

Description:

Patients will be given a Squatty Potty Device

Treatment:

Device: Defecation Posture Modification Device