Use of a Squatting Assist Device in Patients with Constipation

Phase 2

Recruiting

• Conditions: Constipation
• Interventions: Device: Squatting Assist Device; Device: Sham Squatting Assist Device

• Registration Number: NCT02877394
• Lead Sponsor: Mayo Clinic

Brief 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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants.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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-24
• Study Start: 2016-09-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Squatting Assist 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	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.

Primary Outcome Measures

Name	Time	Method
Change in Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency	baseline, 4 weeks	Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States