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

Trial Summary

What is the purpose of this trial?

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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants.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

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 data supports the effectiveness of the treatment Squatting Assist Device for Constipation?

Using a toilet stool to achieve a squatting position is associated with faster and more complete bowel emptying, which may help prevent or treat constipation, as suggested by online reviews of users who reported perceived effectiveness and satisfaction. ^{1 2 3 4 5}

Is the Squatting Assist Device safe for humans?

The available research does not report any safety concerns or side effects related to the use of squatting assist devices, such as toilet stools, for constipation. ^{1 2 3 5 6}

How does the Squatting Assist Device treatment for constipation differ from other treatments?

The Squatting Assist Device is unique because it helps people achieve a squatting position while using the toilet, which can make bowel movements easier and more complete. This approach is different from other treatments like laxatives or biofeedback, as it focuses on changing posture to improve the natural process of defecation. ^{1 2 3 4 5}

Research Team

Adil Bharucha, MBBS, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Using a footstool does not aid simulated defecation in undifferentiated constipation: A randomized trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Portable biofeedback apparatus for treatment of anal sphincter dystonia in childhood soiling and constipation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Can a Defecation Posture Modifying Device Correct an Abnormal Balloon Expulsion Test in Chronically Constipated Patients? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Wheelchair safety--adverse reports to the United States Food and Drug Administration. [2019]