Proof of Concept: "Bottom's Up" Seat to Treat Constipation

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Experimental	"the Bottom's Up"	Pelvic floor support device to treat refractory constipation.

Primary Outcome Measures

Name	Time	Method
Adverse Events	through study completion, approximately one day	The number of participants to report adverse events.

Secondary Outcome Measures

Name	Time	Method
Sense of Staining	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.
Ease of Evacuation	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.
Completeness of Evacuation	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.