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Use of a Squatting Assist Device in Patients With Constipation

NCT02877394 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-01-13

No results posted yet for this study

Summary

Constipation is a very common problem. Western style toilets that are nearly universal in the United States require the person to sit on the toilet. However, results from uncontrolled studies suggests that a squatting posture (as prevalent in many foreign countries) may be better at facilitating evacuation compared to a Western style commode. One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. Hence, the investigators propose to evaluate the benefits of a footstool on symptoms and anorectal functions in constipated patients. Hypothesis: the regular squatting assist device (7 inches) but not a sham device (2 inches tall) will improve symptoms of constipation.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Adil E Bharucha, MBBS, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2025-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02877394 on ClinicalTrials.gov