Postoperative ConstipationNCT06253689
Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair
A study testing Defecation Posture Modification Device in people with Postoperative Constipation and Pelvic Organ Prolapse Vaginal Surgery, run by TriHealth Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Constipation, Pelvic Organ Prolapse Vaginal Surgery, Defecation Function
- What is being tested?
- Defecation Posture Modification Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Feb 2024to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery by one of the sub investigators including a posterior compartment repair
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
About this study
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.
- Being tested
- Defecation Posture Modification Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defecation Posture Modification DeviceDevice
Also called Squatty potty
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.
| Study group | Role | What they receive |
|---|---|---|
| Defecation Posture Modification Device | Experimental | Not described Receives: Device: Defecation Posture Modification Device |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Straining with first postoperative bowel movement
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".
Measured: 1 week
Secondary outcomes (5)
postoperative stool consistency
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.
Measured: 1 week
Time to first bowel movement
7 day log for patients to track bowel movements within 1st week of surgery
Measured: 1 week
pain with postoperative bowel movements
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.
Measured: 1 week
Postoperative use of laxatives and pain medication
patients will keep 7 day log of daily usage of standard postoperative pain medication and laxative use
Measured: 1 week
Satisfaction with device and ease of use
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start19 Feb 2024
- Primary completion15 Feb 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253689
- Sponsor's protocol ID
- 23-087
- Status last verified
- Apr 2025
- First submitted
- 2 Feb 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair
- ClinicalTrials.gov ID
- NCT06253689
- Acronym / sponsor ID
- 23-087
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defecation Posture Modification Device | Experimental | Device: Defecation Posture Modification Device |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgery by one of the sub investigators including a posterior compartment repair
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defecation Posture Modification DeviceAlso: Squatty pottyPatients assigned to the experimental arm will be asked to use the defecation posture modification device to aid with bowel movements during the postoperative period. | Device | Defecation Posture Modification Device |
Primary outcome
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".
5 secondary outcomes
postoperative stool consistency
Time frame: 1 week
Time to first bowel movement
Time frame: 1 week
pain with postoperative bowel movements
Time frame: 1 week
Postoperative use of laxatives and pain medication
Time frame: 1 week
Satisfaction with device and ease of use
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defecation Posture Modification Device in people with Postoperative Constipation and Pelvic Organ Prolapse Vaginal Surgery, run by TriHealth Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Straining with first postoperative bowel movement (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.