- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02419924
Proof of Concept: "Bottom's Up" Seat to Treat Constipation
August 17, 2020 updated by: Mayo Clinic
Proof of Concept: A Commode Assist Device for Excessive Perineal Descent
Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as "the Bottom's Up".
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Efficacy and safety of a unique pelvic floor support device that fits into the Radiology defecography commode will be tested.
Patients with refractory constipation due to known pelvic floor laxity and/or excessive perineal descent will be examined without, then with the device in place.
Patients will complete questionnaires pertaining to device safety and efficacy before and after using the device.
Radiographic images to document efficacy of support plus adequate emptying will be acquired during the study resulting in very low dose radiation exposure.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
10 Males and female subjects greater that 18 years of age with aggravated constipation due to pelvic floor laxity of at least 4 cm and excessive perineal descent of at least 4 cm will be evaluated.
Patients with constipation but no excessive laxity or descent will not be evaluated. Patients must be willing to sign consent, undergo defecography with and without "The Bottom's Up" device.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Pelvic floor support device to treat refractory constipation.
|
A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: through study completion, approximately one day
|
The number of participants to report adverse events.
|
through study completion, approximately one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sense of Staining
Time Frame: post-defecography test, approximately 1 day
|
Sense of straining was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you need to strain hard to empty your rectum'.
The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.
|
post-defecography test, approximately 1 day
|
Ease of Evacuation
Time Frame: post-defecography test, approximately 1 day
|
Ease of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you experience pain/discomfort when you emptied your rectum'.
The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.
|
post-defecography test, approximately 1 day
|
Completeness of Evacuation
Time Frame: post-defecography test, approximately 1 day
|
Completeness of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you feel that you completely emptied your rectum during this test'.
The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.
|
post-defecography test, approximately 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Foxx-Orenstein, DO, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 6, 2015
First Submitted That Met QC Criteria
April 16, 2015
First Posted (Estimate)
April 17, 2015
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
August 17, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-009864
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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