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Squatting Assist Device for Constipation

Phase 2

Recruiting

Led By Adil E Bharucha, MBBS, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Current use of anticholinergics

Current use of laxatives (MiraLax, Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks

Summary

This trial will study whether or not a footstool can help with constipation by improving symptoms and anorectal function.

Who is the study for?

This trial is for individuals who have been experiencing constipation for at least three months and meet specific criteria, such as having fewer than three bowel movements per week or feeling like they can't completely empty their bowels. They must be able to follow the study's procedures and not currently use opioids, certain laxatives, or anticholinergic medications unless they can stop using them before the study starts.

What is being tested?

The trial is testing whether a squatting assist device (a footstool that helps mimic a squatting position) can help relieve symptoms of constipation compared to a sham device. Participants will use either a regular 7-inch tall stool or a sham 2-inch stool to see if there's an improvement in their condition.

What are the potential side effects?

Since this trial involves non-invasive interventions (footstools), side effects are expected to be minimal. However, changing toilet posture could potentially cause discomfort or imbalance for some users until they get used to the new position.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking anticholinergic medication.

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I am currently using medication or supplements to treat constipation.

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I am currently taking opioid painkillers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Squatting Assist DeviceExperimental Treatment1 Intervention

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.

Group II: Sham Squatting Assist DevicePlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met