Use of a Squatting Assist Device in Patients With Constipation
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ClinicalTrials.gov Identifier: NCT02877394 |
Recruitment Status :
Recruiting
First Posted : August 24, 2016
Last Update Posted : September 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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Constipation | Device: Squatting Assist Device Device: Sham Squatting Assist Device | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Use of a Squatting Assist Device in Patients With Constipation |
Actual Study Start Date : | September 1, 2016 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | June 2025 |

Arm | Intervention/treatment |
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Experimental: Squatting Assist Device
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.
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Device: Squatting Assist Device
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.
Other Name: Squatty Potty |
Sham Comparator: Sham Squatting Assist Device
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.
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Device: Sham Squatting Assist Device
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. |
- Change in Mean Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency [ Time Frame: baseline, 4 weeks ]Weekly CSBM Frequency = (Number of CSBMs recorded in 7 days/Number of days with bowel entries in subject diary) X 7

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877394
Contact: Kelly J Feuerhak | 507-255-6802 | Feuerhak.Kelly@mayo.edu |
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Kelly J Feuerhak 507-255-6802 Feuerhak.Kelly@mayo.edu |
Principal Investigator: | Adil E Bharucha, MBBS, MD | Mayo Clinic |
Responsible Party: | Adil Bharucha, MBBS, MD, Professor of Medicine, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT02877394 |
Other Study ID Numbers: |
16-004548 |
First Posted: | August 24, 2016 Key Record Dates |
Last Update Posted: | September 28, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Constipation Signs and Symptoms, Digestive |