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OpenTrials
Completed

NCT Number: NCT06252714

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.

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Key information

Conditions

Pelvic Organ Prolapse Bowel Dysfunction Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Rectal Diseases Rectocele

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bethesda North Hospital, Cincinnati, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Defecation Posture Modification Device

Device

Patients will be asked to use the defecation posture modification device with each bowel movement for two weeks.

Other names: Squatty potty

Primary outcomes

  1. Straining with bowel movements

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Colorectal-Anal Distress Inventory 8

    Time frame: 2 weeks

    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. Consistency of stool

    Time frame: 2 weeks

    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.

  3. Use of laxative medication

    Time frame: 2 weeks

    patients will log any laxative medication used

  4. Ease of device use

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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