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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,953 Total Patients Enrolled

14 Trials studying Constipation

544 Patients Enrolled for Constipation

Adil E Bharucha, MBBS, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Constipation Clinical Trial 2023: Sham Squatting Assist Device Highlights & Side Effects. Trial Name: NCT02877394 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards are associated with Squatting Assist Device use?

"Squatting Assist Device was assigned a score of 2 on our ranking system due to the availability of Phase 2 clinical data that supports its safety but not yet its efficacy."

Answered by AI

What is the maximum number of participants allowed in this study?

"Affirmative. Information hosted on clinicaltrials.gov evinces that this medical experiment, which was posted to the site on September 1st 2016 is currently enrolling participants. 85 human subjects are needed from a single research centre."

Answered by AI

What criteria must one meet in order to be considered for this research?

"To qualify for enrollment in this clinical trial, potential participants must experience dyschezia and be aged between 18 to 80. Approximately 85 individuals will be accepted into the study."

Answered by AI

Is there still room for participants in this research endeavor?

"Per the details on clinicaltrials.gov, this trial remains open and actively recruiting at present. The initial post date was September 1st 2016 with an edit as recently as September 27th 2022."

Answered by AI