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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".
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Start Date
April 1, 2015
Primary Completion Date
December 1, 2016
Completion Date
December 1, 2016
Last Updated
September 2, 2020
12
ACTUAL participants
"the Bottom's Up"
DEVICE
Lead Sponsor
Mayo Clinic
NCT06836024
NCT01312259
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