An interventional study of Defecation Posture Modification Device in Pelvic Organ Prolapse, Rectocele and Bowel Dysfunction, sponsored by TriHealth Inc.. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by TriHealth Inc. · Not applicable, Interventional, and Treatment
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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Exclusion Criteria:
Patients weighing over 250 lbs, per manufacturer guidelines for the device Inability to understand English Pregnant women
Patients will be given a Squatty Potty Device
Device: Defecation Posture Modification Device
Patients will be asked to use the defecation posture modification device with each bowel movement for two weeks.
Also known as: Squatty potty
Straining with bowel movements
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.
Time frame: 2 weeks
Colorectal-Anal Distress Inventory 8
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.
Time frame: 2 weeks
Consistency of stool
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.
Time frame: 2 weeks
Use of laxative medication
patients will log any laxative medication used
Time frame: 2 weeks
Ease of device use
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.
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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