ConstipationPhase 2NCT02877394
Use of a Squatting Assist Device in Patients With Constipation
A Phase 2 study testing Squatting Assist Device in people with Constipation, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Squatting Assist Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study
- Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis: a) <3 SBMs/week b) hard or lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria.
Who cannot join
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal. hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.
- History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
- Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, rectal prolapse, solitary rectal ulcer syndrome, history of rectal resection or pelvic irradiation
- Active cancer
- Pregnant or nursing women, prisoners and institutionalized individuals
- Weight > 300 lbs.
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- Current or Prior use of Squatty Potty®
- Current use of opioid analgesics. Patients on opioids will be allowed to participate if they have discontinued them for at least 3 days (72 hrs.) before date of screening and are willing to stay off them for the duration of the study.
- Current use of anticholinergics (e.g. nortriptyline, amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline upto 50 mg/day or amitriptyline upto 25 mg/day ) will be eligible provided they do not increase the dose during the study period. Patients on higher doses or on other anticholinergics are eligible to participate if they can discontinue their medication at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete.
- Current use of laxatives (MiraLax, Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Constipation
- Being tested
- Squatting Assist Device, Sham Squatting Assist Device
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squatting Assist DeviceDevice
Also called Squatty Potty
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.
Sham Squatting Assist DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Squatting Assist Device | Experimental | 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. Receives: Device: Squatting Assist Device |
| Sham Squatting Assist Device | Sham comparator | 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. Receives: Device: Sham Squatting Assist Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
Subjects completed a bowel diary indicating the number of CSBMs they had each week. Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7
Measured: baseline, 4 weeks
Secondary outcomes (8)
Mean Weekly Spontaneous Bowel Movement (SBM) Frequency
Subjects completed a bowel diary indicating the number of SBMs (bowel movements that occurred without requiring the use of a laxative or enema or of manual disimpaction) they had each week. Weekly SBM frequency= (Number of SBMs recorded in 7 days /Number of days with bowel entries) X 7
Measured: Baseline; 4 weeks
Mean Bristol Stool Form Score (BSFS)
The Bristol Stool Scale classifies human stool into seven types, ranging from hard lumps (1) indicating constipation to watery stools (7) indicating diarrhea. Total scores range from 1 to 7 with higher scores indicating less constipation.
Measured: Baseline; 4 weeks
Straining Severity Score
Straining severity score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more severe straining.
Measured: Baseline; 4 weeks
Worst Abdominal Bloating Score
Worse abdominal bloating score was measured using a 5-point scale. Total scores ranged from 1 to 5 with higher scores indicating more abdominal bloating.
Measured: Baseline; 4 Weeks
Average Overall Relief of Constipation Score
Overall relief of constipation score was measured using a 7-point scale. Scores ranged from 1 (considerably relieved) to 7 (significantly worse) with higher scores indicating worse overall relief. The average scores were calculated through week 2, week 3 and week 4 then combined for a total overall average relief score divided by 3.
Measured: Week 2, Week 3, Week 4
Adequate Relief of Constipation
The number of subjects who reported adequate relief of constipation for ≥ 3 of 4 weeks during treatment period
Measured: Week 1, Week 2, Week 3, Week 4
Satisfaction With Effects of the Foot Stool on Bowel Symptoms
Satisfaction was rated on a 5-point scale from 1 (not at all satisfied) to 5 (very satisfied). Total score ranges from 1-5 with higher scores indicating higher satisfaction.
Measured: 4 Weeks
Perceived Improvement in Constipation With Foot Stool Use
Perceived improvement in constipation with foot stool use was measured using a 100-point scale. Scores ranged from 0 (no improvement) to 100 (extremely improved) with higher scores indicating higher perceived improvement.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start1 Sep 2016
- Primary completion30 Jun 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adil Bharucha, MBBS, MD, Mayo Clinic
- Investigators
- Adil E Bharucha, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877394
- Sponsor's protocol ID
- 16-004548
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2016
- Last updated
- 28 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Squatting Assist Device in Patients With Constipation
- ClinicalTrials.gov ID
- NCT02877394
- Acronym / sponsor ID
- 16-004548
- Conditions
- Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 28 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Squatting Assist Device | Experimental | Device: Squatting Assist DeviceThe 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. |
| Sham Squatting Assist Device | Sham comparator | Device: Sham Squatting Assist DeviceThis 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 may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to communicate adequately with the investigator and to comply with the requirements for the entire study
- Meet Rome III criteria for functional constipation as assessed by questionnaires in period 1, i.e., report at least 2 of the following symptoms for last 3 months or more with symptom onset at least 6 months prior to diagnosis: a) <3 SBMs/week b) hard or lumpy stools ≥ 25% of time c) straining ≥ 25% of time d) sense of incomplete evacuation ≥ 25% of time e) feeling of anorectal blockage ≥ 25% of time or f) manual maneuvers to facilitate defecation ≥ 25% of time. Patients who meet Rome III criteria for irritable bowel syndrome will also be eligible provided they also meet above criteria.
Key exclusion criteria (10 listed)
- Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal. hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.
- History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
- Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, rectal prolapse, solitary rectal ulcer syndrome, history of rectal resection or pelvic irradiation
- Active cancer
- Pregnant or nursing women, prisoners and institutionalized individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Squatting Assist DeviceAlso: Squatty PottyThe 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. | Device | Squatting Assist Device |
| Sham Squatting Assist DeviceThis 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. | Device | Sham Squatting Assist Device |
Primary outcome
Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency
Time frame: baseline, 4 weeks
Subjects completed a bowel diary indicating the number of CSBMs they had each week. Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7
8 secondary outcomes
Mean Weekly Spontaneous Bowel Movement (SBM) Frequency
Time frame: Baseline; 4 weeks
Mean Bristol Stool Form Score (BSFS)
Time frame: Baseline; 4 weeks
Straining Severity Score
Time frame: Baseline; 4 weeks
Worst Abdominal Bloating Score
Time frame: Baseline; 4 Weeks
Average Overall Relief of Constipation Score
Time frame: Week 2, Week 3, Week 4
Adequate Relief of Constipation
Time frame: Week 1, Week 2, Week 3, Week 4
Satisfaction With Effects of the Foot Stool on Bowel Symptoms
Time frame: 4 Weeks
Perceived Improvement in Constipation With Foot Stool Use
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adil E Bharucha, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Squatting Assist Device in people with Constipation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency (time frame: baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.