N/A
N=12
Proof of Concept: "Bottom's Up" Seat to Treat Constipation
Constipation Aggravated · Pelvic Floor; Incompetency
Bottom Line
View on ClinicalTrials.gov: NCT02419924 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- "the Bottom's Up" (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
— | — |
| SECONDARY Sense of Staining |
6.1 | — |
| SECONDARY Ease of Evacuation |
2.9 | — |
| SECONDARY Completeness of Evacuation |
5.3 | — |
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".
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02419924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.