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OpenTrials
Completed

NCT Number: NCT06253689

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bethesda North Hospital, Cincinnati, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Defecation Posture Modification Device

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

Primary outcomes

  1. Straining with first postoperative bowel movement

    Time frame: 1 week

    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".

Secondary outcomes

  1. postoperative stool consistency

    Time frame: 1 week

    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.

  2. Time to first bowel movement

    Time frame: 1 week

    7 day log for patients to track bowel movements within 1st week of surgery

  3. pain with postoperative bowel movements

    Time frame: 1 week

    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.

  4. Postoperative use of laxatives and pain medication

    Time frame: 1 week

    patients will keep 7 day log of daily usage of standard postoperative pain medication and laxative use

  5. Satisfaction with device and ease of use

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
Apr 18, 2025

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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