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Completed

NCT Number: NCT02419924

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

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".

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Key information

Conditions

Constipation Aggravated Pelvic Floor; Incompetency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"the Bottom's Up"

Device

A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.

Other names: Pelvic floor support device to treat refractory constipation

Primary outcomes

  1. Adverse Events

    Time frame: through study completion, approximately one day

    The number of participants to report adverse events.

Secondary outcomes

  1. Sense of Staining

    Time frame: 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.

  2. Ease of Evacuation

    Time frame: 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.

  3. Completeness of Evacuation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2015
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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