Use of a Squatting Assist Device in Patients With Constipation

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified May 2026 by Mayo Clinic
Sponsor
Mayo Clinic
Information Provided by (Responsible Party)
Adil Bharucha, MBBS, MD
Clinicaltrials.gov Identifier
NCT02877394
Other Study ID Numbers:
16-004548
First Submitted
August 18, 2016
First Posted
August 23, 2016
Results First Posted
June 28, 2026
Last Update Posted
July 27, 2026
Last Verified
May 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Constipation
Device: Squatting Assist DeviceDevice: Sham Squatting Assist Device

Study Design

Study TypeInterventional
Actual Enrollment107 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleUse of a Squatting Assist Device in Patients With Constipation
Study Start DateAugust 31, 2016
Actual Primary Completion DateJune 29, 2025
Actual Study Completion Date2mos 3w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Device: 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 will be 2 inches tall and be similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
Device: Sham Squatting Assist Device
This stool will be 2 inches tall and be similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.

Outcome Measures

Primary Outcome Measures
  1. Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
    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
Secondary Outcome Measures
  1. Mean Weekly Spontaneous Bowel Movement (SBM) Frequency
    Subjects 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
  2. Mean Bristol Stool Form Score (BSFS)
    The 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.
  3. Straining Severity Score
    Straining severity score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more severe straining.
  4. Worst Abdominal Bloating Score
    Worse abdominal bloating score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more abdominal bloating.
  5. Average Overall Relief of Constipation Score
    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.
  6. Adequate Relief of Constipation
    The number of subjects who reported adequate relief of constipation for ≥ 3 of 4 weeks during treatment period
  7. Satisfaction With Effects of the Foot Stool on Bowel Symptoms
    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.
  8. Perceived Improvement in Constipation With Foot Stool Use
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion criteria:
Able to communicate adequately with the investigator and to comply with the requirements for the entire study
Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis: a) \<3 SBMs/week b) hard or lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria.
Exclusion Criteria
Inclusion criteria:
Able to communicate adequately with the investigator and to comply with the requirements for the entire study
Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis: a) \<3 SBMs/week b) hard or lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria. Exclusion criteria:
Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal. hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.
History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, rectal prolapse, solitary rectal ulcer syndrome, history of rectal resection or pelvic irradiation
Active cancer
Pregnant or nursing women, prisoners and institutionalized individuals
Weight \> 300 lbs.
Current or Prior use of Squatty Potty®
Current use of opioid analgesics. Patients on opioids will be allowed to participate if they have discontinued them for at least 3 days (72 hrs.) before date of screening and are willing to stay off them for the duration of the study.
Current use of anticholinergics (e.g. nortriptyline, amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline upto 50 mg/day or amitriptyline upto 25 mg/day ) will be eligible provided they do not increase the dose during the study period. Patients on higher doses or on other anticholinergics are eligible to participate if they can discontinue their medication at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete.
Current use of laxatives (MiraLax, Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete.

Contacts and Locations

Sponsors and CollaboratorsMayo Clinic
Locations
Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905
Investigators
Principal Investigator: Adil E Bharucha, MBBS, MD, Mayo Clinic
Study Documents (Full Text)
Documents provided by Mayo Clinic: Study Protocol and Statistical Analysis Plan  March 6, 2024