Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 14-009864
NCT ID: NCT02419924
Sponsor Protocol Number: 14-009864
About this study
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".
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Males and female
- greater that 18 years of age
- aggravated constipation due to pelvic floor laxity of at least 4 cm and excessive perineal descent of at least 4 cm
- willing to sign consent
- undergo defecography with and without "The Bottom's Up" device
Exclusion Criteria
- constipation but no excessive laxity or descent will not be evaluated
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amy Foxx-Orenstein, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available