Pelvic Organ Prolapse Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | April 1, 2025 |
| Est. primary completion date | March 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Bethesda North Hospital | Cincinnati | Ohio |
| United States | Cincinnati Urogynecology Associates | Cincinnati | Ohio |
| United States | Good Samaritan Hospital | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| TriHealth Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 2 weeks | |
| Secondary | 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. | 2 weeks | |
| Secondary | 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. | 2 weeks | |
| Secondary | Use of laxative medication | patients will log any laxative medication used | 2 weeks | |
| Secondary | 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. | 2 weeks |
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|---|---|---|---|
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