Squatting Assist Device for Constipation

Overseen By Kelly J Feuerhak

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Opioids, Anticholinergics, Laxatives

Disqualifiers: Opioid use, Anticholinergic use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special footstool can relieve constipation by encouraging a squatting posture while using the toilet. Researchers compare a 7-inch squatting aid (Squatting Assist Device) to a 2-inch sham stool (Sham Squatting Assist Device) to determine if a higher stool improves bowel symptoms. The trial seeks participants who have experienced constipation for at least three months, particularly those with difficulty passing stool or a feeling of blockage. This study may suit individuals struggling with bowel movements who wish to try a non-medicinal approach. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications to join this trial. If you are using opioids, anticholinergics, or laxatives, you must stop them at least 3 days before the screening and stay off them during the study. However, low doses of some antidepressants are allowed if the dose remains unchanged.

What prior data suggests that this squatting assist device is safe for constipation?

Research has shown that using a squatting aid, such as the Squatty Potty, is safe for most people. An unpublished study found that a footstool improved bowel symptoms in nearly 98% of participants with constipation, indicating that the device is both effective and easy to use.

No major risks appear to exist for most people when using these footstools. However, individuals with ongoing constipation or other digestive issues should consult a doctor first. Overall, evidence suggests that the squatting aid is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Squatting Assist Device for constipation because it introduces a new approach to improving bowel movements by promoting a natural squatting position. Unlike traditional treatments, such as laxatives or dietary changes, this device physically alters the posture during toilet use to potentially ease bowel movements more naturally. The device is designed to elevate the feet and mimic a more natural squatting position, which may enhance the efficiency of the colon. This simple, non-invasive method could offer a safer and more convenient option for individuals seeking relief from constipation.

What evidence suggests that the Squatting Assist Device is effective for constipation?

Research has shown that squatting might help with constipation. In one study, nearly 98% of 153 people with constipation felt better when they used a footstool. Another review found that squatting can ease bowel movements and reduce digestive strain compared to sitting. In this trial, participants will use either a Squatting Assist Device or a Sham Squatting Assist Device. Previous studies suggest that a device aiding squatting showed better results for those with constipation. Overall, these findings indicate that a squatting device could help relieve constipation symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Adil Bharucha, MBBS, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with irritable bowel syndrome according to Rome III criteria.

Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1

I can communicate well and follow study instructions.

Exclusion Criteria

I am currently taking anticholinergic medication.

I am currently using medication or supplements to treat constipation.

I am currently taking opioid painkillers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a 7-inch Squatty Potty or a 2-inch sham device to assist in maintaining a squatting position while using a toilet

4 weeks

Weekly diary entries

Follow-up

Participants are monitored for changes in bowel movement frequency and symptoms after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Squatting Assist Device
• Squatting Assist Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Squatting Assist Device Experimental Treatment 1 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 Device Placebo Group 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A study analyzing 651 FDA records from 1975 to 1993 found that wheelchair-related injuries are common, with 368 injuries reported, including 21 fatalities, primarily involving fractures (45.5%).

The majority of incidents were linked to engineering factors (60.5%), highlighting the need for improved design and safety measures in wheelchairs and scooters to prevent injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheelchair safety--adverse reports to the United States Food and Drug Administration. Kirby, RL., Ackroyd-Stolarz, SA.[2019]

In a study of 41 patients with constipation, using a footstool significantly changed the defecatory posture by narrowing the angle between the spine and femur, indicating a more optimal position for bowel evacuation.

Despite these postural changes, the use of a footstool did not improve the time taken for simulated defecation or subjective feelings of ease and discomfort, suggesting that footstools may not be beneficial for all patients with constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a footstool does not aid simulated defecation in undifferentiated constipation: A randomized trial. Trieu, RQ., Prott, G., Sequeira, C., et al.[2023]

A study analyzing 10,027 customer reviews of toilet stools found that users rated their perceived effectiveness and overall satisfaction very high, indicating that these stools may effectively help with constipation.

The use of toilet stools appears to be safe, with less than 1% of users reporting adverse effects, suggesting a favorable risk-benefit ratio for preventing or treating constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Effectiveness and Overall Satisfaction of Using a Toilet Stool to Prevent or Treat Constipation: An Analysis of Online Comments. Sebo, P., Quinio, C., Viry, M., et al.[2022]

Constipation significantly affects the quality of life and health costs for the elderly, potentially leading to serious gastrointestinal issues like colon cancer and hemorrhoids.

The review highlights the need for assistive devices that help older adults achieve a semi-squatting posture for defecation, addressing the challenges posed by musculoskeletal issues and lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review on squat-assist devices to aid elderly with lower limb difficulties in toileting to tackle constipation. Hari Krishnan, R.[2019]

Defecation posture-modifying devices (DPMDs) may help improve constipation symptoms by mimicking the benefits of squatting, which can enhance stool evacuation by straightening the anorectal angle and relaxing the pelvic floor.

The effectiveness of DPMDs in normalizing anorectal function in adults with chronic constipation has not yet been studied, indicating a gap in research that could inform future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a Defecation Posture Modifying Device Correct an Abnormal Balloon Expulsion Test in Chronically Constipated Patients? Koo, E., Chey, WD., Ezell, G., et al.[2023]

The Easograph, a portable anorectal biofeedback device designed for home use, has shown promise in treating anal sphincter dysfunction in children with constipation and soiling, making the treatment more accessible and user-friendly.

In a pilot study involving eight patients, five achieved bowel continence within one to eight weeks of daily practice, indicating the device's potential effectiveness in improving anal sphincter control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable biofeedback apparatus for treatment of anal sphincter dystonia in childhood soiling and constipation. Griffiths, P., Dunn, S., Evans, A., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12219158/

Sitting vs. squatting: a scoping review of toilet postures and ... Squatting may reduce digestive strain and enhance bowel evacuation, potentially benefiting constipation, while sitting toilets may increase ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02877394?draw=2&rank=1

Study Details | NCT02877394 | Use of a Squatting Assist ... Hypothesis: the regular squatting assist device (7 inches) but not a sham device (2 inches tall) will improve symptoms of constipation.

3. trialx.com trialx.com/clinical-trials/listings/269252/use-of-a-squatting-assist-device-in-patients-with-constipation/

Use of a Squatting Assist Device in Patients With ... One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. Hence, the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6382038/

Implementation of a Defecation Posture Modification Device DPMD improved straining outcomes for participants who reported constipation (OR, 0.08 vs. 0.28; P<0.001) and participants who reported decreased ...

5. researchgate.net researchgate.net/publication/362339508_Perceived_Effectiveness_and_Overall_Satisfaction_of_Using_a_Toilet_Stool_to_Prevent_or_Treat_Constipation_An_Analysis_of_Online_Comments

Perceived Effectiveness and Overall Satisfaction of Using a ... Conclusion: Perceived effectiveness and overall satisfaction were rated high by those who purchased a toilet stool online. In addition, their ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20308686

A Study of the Use of a Squatting Assist Device in Patients ... One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. The purpose of this study ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05287789

Effectiveness of Squatting Position on Constipation ... The aim of the study was to determine the effectiveness of the squatting position with footstool on the constipation severity and defecation problems in the ...

8. webmd.com webmd.com/digestive-disorders/squatty-potty-what-is

Squatty Potty (Poop Stool): Does it Really Work? There don't seem to be any risks to using these footstools. But if you have chronic constipation or any other GI symptoms, check with your ...