Squatting Assist Device for Constipation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Prior Safety Data
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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants.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.
12345Is 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.
12356How 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.
12345Eligibility 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.Exclusion Criteria
I am currently taking anticholinergic medication.
I am currently using medication or supplements to treat constipation.
I am currently taking opioid painkillers.
Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
Using a footstool does not aid simulated defecation in undifferentiated constipation: A randomized trial. [2023]The use of a footstool has been advocated to optimize posture when sitting on the toilet and thus facilitate bowel evacuation. We aimed to assess the alterations in defecatory posture, and the changes in simulated defecation with use of a footstool in patients with constipation.
A review on squat-assist devices to aid elderly with lower limb difficulties in toileting to tackle constipation. [2019]Constipation is an important issue that has impact on quality of life and health expenses of the elderly. It may lead to many other gastrointestinal disorders like colon cancer, haemorrhoids, anal fissures and so on. Squatting is considered to be the natural, traditional and most widely followed posture for defecation and hence, it is one of the practical solutions for avoiding constipation. Musculoskeletal issues due to ageing and changes in lifestyle make it difficult for the elder population to follow squatting or semi-squatting posture for defecation. Developing assistive devices to overcome older people's difficulty to attain squatting or semi-squatting posture is one of the research areas which need to be explored further. This review covers various designs of such devices which will enable a user to attain 'semi-squatting' posture to defecate and also addresses various challenges and limitations to overcome.
Perceived Effectiveness and Overall Satisfaction of Using a Toilet Stool to Prevent or Treat Constipation: An Analysis of Online Comments. [2022]Constipation is a common complaint in the general population. Squatting (using a toilet stool) is associated with faster and more complete bowel emptying, and could therefore help prevent or treat constipation. We analyzed the reviews of online buyers of a toilet stool to assess perceived effectiveness, overall satisfaction and potential side effects.
Portable biofeedback apparatus for treatment of anal sphincter dystonia in childhood soiling and constipation. [2019]Biofeedback is an effective treatment for anal sphincter dysfunction in many cases of childhood constipation and soiling. Conventional methodologies centre on clinic-based manometric apparatus but are compromised by equipment being thinly available and practice sessions often infrequent. To counter these shortcomings, we have designed a portable anorectal biofeedback apparatus (the Easograph) for domiciliary use. It can be lent to families, enabling carers to mediate what is an intrinsically sensitive procedure. In this paper, we provide a technical description of the device which is based on an inexpensive pressure transducer. Casework experience suggests it is reliable in operation and readily understood by users. In a pilot study of eight patients treated with the apparatus, five achieved bowel continence after lifelong soiling in one to eight weeks of daily practice. We believe this is an innovative approach that has good potential for treating faecal retentive and expulsive disorders in childhood associated with poor anal sphincter control.
Can a Defecation Posture Modifying Device Correct an Abnormal Balloon Expulsion Test in Chronically Constipated Patients? [2023]Evacuation disorders are common among chronically constipated (CC) patients who fail to respond to laxatives and are typically diagnosed by anorectal manometry (ARM) and/or balloon expulsion testing (BET).1,2 Recently, there has been emerging interest in the use of defecation posture-modifying devices (DPMDs) to improve constipation symptoms, presumably by replicating the physiologic benefits of squatting on stool evacuation, such as straightening of the anorectal angle and relaxing the pelvic floor. However, the ability of DPMDs to normalize anorectal function in adult patients with CC has not been studied.
Wheelchair safety--adverse reports to the United States Food and Drug Administration. [2019]Evidence has been accumulating that injuries related to wheelchair use are common and sometimes serious. The object of this study was to evaluate the databases of the Food and Drug Administration (FDA) for insights to the nature and causes of such problems. We analyzed 651 records that were received by the FDA between 1975 and 1993. There were 368 injuries, 21 of which were fatal, affecting 334 wheelchair users. Fractures were the most common (45.5%), with lacerations (22.3%) and contusions/abrasions (20.1%) accounting for most of the remainder. The proportion of incidents related to the use of scooters, powered wheelchairs, and manual wheelchairs were 52.8%, 24.6%, and 22.6%, respectively. Four broad classes of contributing factors, often acting in combination, were implicated: engineering (60.5%), environmental (25.4%), occupant (9.6%), and system (4.6%). Of the tips and falls, those in the forward direction were most common in incidents affecting manual or powered wheelchairs, but the sideways direction was most common in scooters. The FDA database provides a unique perspective on wheelchair safety, with implications for clinicians, users, manufacturers, and regulatory bodies.