Trial Outcomes & Findings for Proof of Concept: "Bottom's Up" Seat to Treat Constipation (NCT NCT02419924)

Results Overview

The number of participants to report adverse events.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

through study completion, approximately one day

Results posted on

2020-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Pelvic floor support device to treat refractory constipation. "the Bottom's Up": A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=12 Participants Pelvic floor support device to treat refractory constipation. "the Bottom's Up": A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Age, Continuous	54 years STANDARD_DEVIATION 18.4 • n=12 Participants
Sex: Female, Male Female	12 Participants n=12 Participants
Sex: Female, Male Male	0 Participants n=12 Participants
Region of Enrollment United States	12 Participants n=12 Participants

PRIMARY outcome

Timeframe: through study completion, approximately one day

The number of participants to report adverse events.

Outcome measures

Outcome measures
Measure	Experimental n=12 Participants Pelvic floor support device to treat refractory constipation. "the Bottom's Up": A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Adverse Events	0 Participants

SECONDARY outcome

Timeframe: post-defecography test, approximately 1 day

Population: Two subjects did not complete the questionnaire

Sense of straining was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you need to strain hard to empty your rectum'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.

Outcome measures

Outcome measures
Measure	Experimental n=10 Participants Pelvic floor support device to treat refractory constipation. "the Bottom's Up": A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Sense of Staining	6.1 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: post-defecography test, approximately 1 day

Population: Two subjects did not complete the questionnaire

Ease of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you experience pain/discomfort when you emptied your rectum'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.

Outcome measures

Outcome measures
Measure	Experimental n=10 Participants Pelvic floor support device to treat refractory constipation. "the Bottom's Up": A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Ease of Evacuation	2.9 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: post-defecography test, approximately 1 day

Population: Two subjects did not complete the questionnaire

Completeness of evacuation was measured using the self-reported answer to the modified Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) question of 'Did you feel that you completely emptied your rectum during this test'. The Likert scale questionnaire scores ranged from 0-10 where 0 = No, not at all and 10 = Yes, quite a bit.

Outcome measures

Outcome measures
Measure	Experimental n=10 Participants Pelvic floor support device to treat refractory constipation. "the Bottom's Up": A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
Completeness of Evacuation	5.3 score on a scale Standard Deviation 3.0

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Foxx-Orenstein

Mayo Clinic

Phone: 480-301-6990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place