Use of a Squatting Assist Device in Patients With Constipation

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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants.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

• Status: Active, not recruiting
• Conditions: Constipation
• Intervention / Treatment: Device: Squatting Assist Device; Device: Sham Squatting Assist Device

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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	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.	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.	4 Weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Adil E Bharucha, MBBS, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimated): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation
• Other Study ID Numbers: 16-004548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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