Trial Outcomes & Findings for Use of a Squatting Assist Device in Patients With Constipation (NCT NCT02877394)
NCT ID: NCT02877394
Last Updated: 2026-07-28
Results Overview
Subjects completed a bowel diary indicating the number of CSBMs they had each week. Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
baseline, 4 weeks
Results posted on
2026-07-28
Participant Flow
107 subjects were enrolled however 43 subjects were excluded prior to randomization due to 25 subjects screen failing and 18 subjects withdrawing.
Participant milestones
| Measure |
Squatting Assist Device
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Squatting Assist Device in Patients With Constipation
Baseline characteristics by cohort
| Measure |
Squatting Assist Device
n=31 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=33 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
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Sex: Female, Male
Female
|
31 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
64 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 16.5 • n=20 Participants
|
50.3 years
STANDARD_DEVIATION 12.0 • n=20 Participants
|
46.5 years
STANDARD_DEVIATION 14.8 • n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=20 Participants
|
33 participants
n=20 Participants
|
64 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 weeksSubjects completed a bowel diary indicating the number of CSBMs they had each week. Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7
Outcome measures
| Measure |
Squatting Assist Device
n=31 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=33 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
Baseline
|
0.8 bowel movements per week
Standard Deviation 0.8
|
0.9 bowel movements per week
Standard Deviation 1.0
|
|
Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
4 Weeks
|
1.6 bowel movements per week
Standard Deviation 1.8
|
1.2 bowel movements per week
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline; 4 weeksSubjects completed a bowel diary indicating the number of SBMs (bowel movements that occurred without requiring the use of a laxative or enema or of manual disimpaction) they had each week. Weekly SBM frequency= (Number of SBMs recorded in 7 days /Number of days with bowel entries) X 7
Outcome measures
| Measure |
Squatting Assist Device
n=31 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=33 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Mean Weekly Spontaneous Bowel Movement (SBM) Frequency
Baseline
|
5.2 bowel movements per week
Standard Deviation 4.2
|
5.7 bowel movements per week
Standard Deviation 4.3
|
|
Mean Weekly Spontaneous Bowel Movement (SBM) Frequency
4 weeks
|
5.3 bowel movements per week
Standard Deviation 3.5
|
6.3 bowel movements per week
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline; 4 weeksThe Bristol Stool Scale classifies human stool into seven types, ranging from hard lumps (1) indicating constipation to watery stools (7) indicating diarrhea. Total scores range from 1 to 7 with higher scores indicating less constipation.
Outcome measures
| Measure |
Squatting Assist Device
n=31 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=33 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Mean Bristol Stool Form Score (BSFS)
Baseline
|
3.2 score on a scale
Standard Deviation 1.2
|
2.8 score on a scale
Standard Deviation 1.6
|
|
Mean Bristol Stool Form Score (BSFS)
4 Weeks
|
3.3 score on a scale
Standard Deviation 1.0
|
2.9 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline; 4 weeksStraining severity score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more severe straining.
Outcome measures
| Measure |
Squatting Assist Device
n=31 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=33 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Straining Severity Score
Baseline
|
2.6 score on a scale
Standard Deviation 0.6
|
3.0 score on a scale
Standard Deviation 0.9
|
|
Straining Severity Score
4 Weeks
|
2.3 score on a scale
Standard Deviation 0.7
|
2.7 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline; 4 WeeksWorse abdominal bloating score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more abdominal bloating.
Outcome measures
| Measure |
Squatting Assist Device
n=31 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=33 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Worst Abdominal Bloating Score
Baseline
|
2.8 score on a scale
Standard Deviation 0.7
|
2.6 score on a scale
Standard Deviation 1.1
|
|
Worst Abdominal Bloating Score
4 Weeks
|
2.7 score on a scale
Standard Deviation 0.9
|
2.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 2, Week 3, Week 4Population: 1 subject in the Squatting Assist Device arm did not return the questionnaire and 2 subjects in the Sham Squatting Assist Device arm did not return the questionnaire.
Overall relief of constipation score was measured using a 7-point scale. Scores ranged from 1 (considerably relieved) to 7 (significantly worse) with higher scores indicating worse overall relief. The average scores were calculated through week 2, week 3 and week 4 then combined for a total overall average relief score divided by 3.
Outcome measures
| Measure |
Squatting Assist Device
n=30 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=31 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Average Overall Relief of Constipation Score
|
3.6 score on a scale
Standard Deviation 0.8
|
3.9 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4Population: 6 subjects in the Squatting Assist Device arm and 6 subjects in the Sham Squatting Assist Device arm did not complete the questionnaire.
The number of subjects who reported adequate relief of constipation for ≥ 3 of 4 weeks during treatment period
Outcome measures
| Measure |
Squatting Assist Device
n=25 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=27 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Adequate Relief of Constipation
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: 5 subjects in the Squatting Assist Device arm and 3 subjects in the Sham Squatting Assist Device arm did not complete the questionnaire.
Satisfaction was rated on a 5-point scale from 1 (not at all satisfied) to 5 (very satisfied). Total score ranges from 1-5 with higher scores indicating higher satisfaction.
Outcome measures
| Measure |
Squatting Assist Device
n=26 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=30 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Satisfaction With Effects of the Foot Stool on Bowel Symptoms
|
2.7 score on a scale
Standard Deviation 1.1
|
2.4 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: 5 subjects in the Squatting Assist Device arm and 2 subjects in the Sham Squatting Assist Device arm did not complete the questionnaire.
Perceived improvement in constipation with foot stool use was measured using a 100-point scale. Scores ranged from 0 (no improvement) to 100 (extremely improved) with higher scores indicating higher perceived improvement.
Outcome measures
| Measure |
Squatting Assist Device
n=26 Participants
The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
Squatting Assist Device: The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
|
Sham Squatting Assist Device
n=31 Participants
This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Sham Squatting Assist Device: This stool is 2 inches tall and is similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
|
|---|---|---|
|
Perceived Improvement in Constipation With Foot Stool Use
|
39.9 score on a scale
Standard Deviation 27.8
|
29 score on a scale
Standard Deviation 27.8
|
Adverse Events
Squatting Assist Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Squatting Assist Device
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place