NCT02419924

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

Proof of Concept: A Commode Assist Device for Excessive Perineal Descent

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Constipation Aggravated
• Pelvic Floor; Incompetency

Interventions

Type	Name	Description
DEVICE	"the Bottom's Up"	A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-04-17
• Last updated: 2020-09-02
• Results posted: 2020-09-02

Locations

1 site across 1 country: United States