Trials Sponsors Conditions Drugs Pricing

Conditions

Constipation Aggravated Pelvic Floor; Incompetency

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Sense of Staining
post-defecography test, approximately 1 day
Ease of Evacuation
post-defecography test, approximately 1 day
Completeness of Evacuation
post-defecography test, approximately 1 day

Study Arms (1)

Experimental

EXPERIMENTAL

Pelvic floor support device to treat refractory constipation.

Device: "the Bottom's Up"

Interventions

"the Bottom's Up"Device

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

Also known as: Pelvic floor support device to treat refractory constipation

Experimental

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Mayo Clinic
Otherlead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Results Point of Contact

Title: Dr. Amy Foxx-Orenstein
Organization: Mayo Clinic

Study Officials

Amy Foxx-Orenstein, DO
Mayo Clinic
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 17, 2015

Study Start

April 2015

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Links

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Links

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations