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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02419924
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Constipation Aggravated; Pelvic Floor; Incompetency	Device: "the Bottom's Up"	N/A

Detailed Description

Efficacy and safety of a unique pelvic floor support device that fits into the Radiology defecography commode will be tested. Patients with refractory constipation due to known pelvic floor laxity and/or excessive perineal descent will be examined without, then with the device in place. Patients will complete questionnaires pertaining to device safety and efficacy before and after using the device. Radiographic images to document efficacy of support plus adequate emptying will be acquired during the study resulting in very low dose radiation exposure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Proof of Concept: A Commode Assist Device for Excessive Perineal Descent
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Pelvic floor support device to treat refractory constipation.	Device: "the Bottom's Up"; A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.; Other Names: Pelvic floor support device to treat refractory constipation

Outcome Measures

Primary Outcome Measures

1. Adverse Events [through study completion, approximately one day]

   The number of participants to report adverse events.

Secondary Outcome Measures

1. Sense of Staining [post-defecography test, approximately 1 day]

   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.

2. Ease of Evacuation [post-defecography test, approximately 1 day]

   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.

3. Completeness of Evacuation [post-defecography test, approximately 1 day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Amy Foxx-Orenstein, DO, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2016

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02419924
• Other Study ID Numbers: 14-009864
• First Posted: Apr 17, 2015
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Constipation

Study Results

Participant Flow

Arm/Group Title	Experimental
Arm/Group Description	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.
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Experimental
Arm/Group Description	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 Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54 (18.4)
Sex: Female, Male (Count of Participants)
Female	12 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	12 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental
Arm/Group Description	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.
Measure Participants	12
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Sense of Staining
Description	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.
Time Frame	post-defecography test, approximately 1 day

Outcome Measure Data

Analysis Population Description

Two subjects did not complete the questionnaire

Arm/Group Title	Experimental
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [score on a scale]	6.1 (2.8)

3. Secondary Outcome

Title	Ease of Evacuation
Description	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.
Time Frame	post-defecography test, approximately 1 day

Outcome Measure Data

Analysis Population Description

Two subjects did not complete the questionnaire

Arm/Group Title	Experimental
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [score on a scale]	2.9 (3.4)

4. Secondary Outcome

Title	Completeness of Evacuation
Description	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.
Time Frame	post-defecography test, approximately 1 day

Outcome Measure Data

Analysis Population Description

Two subjects did not complete the questionnaire

Arm/Group Title	Experimental
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [score on a scale]	5.3 (3.0)

Adverse Events

Time Frame	Adverse event data were collected for the duration each subject was enrolled in the study, one day.
Arm/Group Title	Experimental
Arm/Group Description	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.
All Cause Mortality
	Experimental
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Experimental
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.