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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06252714
Other study ID # 23-090
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date April 1, 2025

Study information

Verified date February 2024
Source TriHealth Inc.
Contact Meredith Carrel-Lammert
Phone 513-463-4300
Email meredith_Carrel-lammert@Trihealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Defecation Posture Modification Device
Patients will be asked to use the defecation posture modification device with each bowel movement for two weeks.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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