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

Pelvic Floor; Incompetency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419924
• Other study ID #: 14-009864
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Constipation Aggravated
• Pelvic Floor; Incompetency

Intervention

Device:
• "the Bottom's Up"
A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	The number of participants to report adverse events.	through study completion, approximately one day
Secondary	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.	post-defecography test, approximately 1 day
Secondary	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.	post-defecography test, approximately 1 day
Secondary	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.	post-defecography test, approximately 1 day

External Links

•   Mayo Clinic Clinical Trials