Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair
- Conditions
- Pelvic Organ Prolapse Vaginal SurgeryPostoperative ConstipationDefecation Function
- Interventions
- Device: Defecation Posture Modification Device
- Registration Number
- NCT06253689
- Lead Sponsor
- TriHealth Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- Patients undergoing surgery by one of the sub investigators including a posterior compartment repair
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Defecation Posture Modification Device Defecation Posture Modification Device -
- Primary Outcome Measures
Name Time Method Straining with first postoperative bowel movement 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 Outcome Measures
Name Time Method Time to first bowel movement 1 week 7 day log for patients to track bowel movements within 1st week of surgery
pain with postoperative bowel movements 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.
postoperative stool consistency 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.
Postoperative use of laxatives and pain medication 1 week patients will keep 7 day log of daily usage of standard postoperative pain medication and laxative use
Satisfaction with device and ease of use 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.
Trial Locations
- Locations (3)
Cincinnati Urogynecology Associates
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States