Squatting Assist Device for Constipation

Mayo Clinic in Rochester, Rochester, MN
ConstipationSquatting Assist Device - Device
Eligibility
18 - 80
Female

Study Summary

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: baseline, 4 weeks

baseline, 4 weeks
Change in Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Squatting Assist Device
1 of 2
Sham Squatting Assist Device
1 of 2

Experimental Treatment

Non-Treatment Group

85 Total Participants · 2 Treatment Groups

Primary Treatment: Squatting Assist Device · Has Placebo Group · Phase 2

Squatting Assist Device
Device
Experimental Group · 1 Intervention: Squatting Assist Device · Intervention Types: Device
Sham Squatting Assist Device
Device
ShamComparator Group · 1 Intervention: Sham Squatting Assist Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 4 weeks

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,008 Previous Clinical Trials
3,513,384 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

Eligibility Criteria

Age 18 - 80 · Female Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are individuals in their fifties eligible to join this experiment?

"The upper limit on participants for this research study is 80 years old, with the minimum age set at 18." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.