NCT02419924

Brief 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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

April 6, 2015

Results QC Date

August 17, 2020

Last Update Submit

August 17, 2020

Conditions

Constipation AggravatedPelvic 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

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

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

Results Point of Contact

Title
Dr. Amy Foxx-Orenstein
Organization
Mayo Clinic
foxx-orenstein.amy@mayo.edu
480-301-6990

Study Officials

  • Amy Foxx-Orenstein, DO

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 2, 2020

Results First Posted

September 2, 2020

Record last verified: 2020-08

Locations

US(1)