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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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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

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Constipation Aggravated Pelvic Floor; Incompetency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Pelvic floor support device to treat refractory constipation.

Group Type EXPERIMENTAL

"the Bottom's Up"

Intervention Type DEVICE

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

Interventions

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"the Bottom's Up"

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

Intervention Type DEVICE

Other Intervention Names

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Pelvic floor support device to treat refractory constipation

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes