Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Status: | Completed |
---|---|
Conditions: | Constipation |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/22/2017 |
Start Date: | April 2015 |
End Date: | December 2016 |
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".
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.
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.
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.
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