Back to resultsProof of Concept: "Bottom's Up" Seat to Treat Constipation
Primary Purpose
Constipation Aggravated, Pelvic Floor; Incompetency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"the Bottom's Up"
Sponsored by
About this trial
This is an interventional treatment trial for Constipation Aggravated
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Pelvic floor support device to treat refractory constipation.
Outcomes
Primary Outcome Measures
Adverse Events
The number of participants to report adverse events.
Secondary Outcome Measures
Sense of Staining
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.
Ease of Evacuation
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.
Completeness of Evacuation
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419924
Brief Title
Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Official Title
Proof of Concept: A Commode Assist Device for Excessive Perineal Descent
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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".
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation Aggravated, Pelvic Floor; Incompetency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Pelvic floor support device to treat refractory constipation.
Intervention Type
Device
Intervention Name(s)
"the Bottom's Up"
Other Intervention Name(s)
Pelvic floor support device to treat refractory constipation
Intervention Description
A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Primary Outcome Measure Information:
Title
Adverse Events
Description
The number of participants to report adverse events.
Time Frame
through study completion, approximately one day
Secondary Outcome Measure Information:
Title
Sense of Staining
Description
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.
Time Frame
post-defecography test, approximately 1 day
Title
Ease of Evacuation
Description
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.
Time Frame
post-defecography test, approximately 1 day
Title
Completeness of Evacuation
Description
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.
Time Frame
post-defecography test, approximately 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Foxx-Orenstein, DO
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Proof of Concept: "Bottom's Up" Seat to Treat Constipation
We'll reach out to this number within 24 hrs