Use of a Squatting Assist Device in Patients With Constipation

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified December 2025 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
Last Update Posted
January 12, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 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 Enrollment85 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 Date6mos 2w 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. Change in Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
    Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7

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:
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