Use of a Squatting Assist Device in Patients With Constipation

NCT02877394 | Active Not Recruiting Phase 2 Results FDA Device

• 1 other identifier: 16-004548
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants.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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mean Weekly Spontaneous Bowel Movement (SBM) Frequency

  Baseline; 4 weeks

• Mean Bristol Stool Form Score (BSFS)

  Baseline; 4 weeks

• Straining Severity Score

  Baseline; 4 weeks

• Worst Abdominal Bloating Score

  Baseline; 4 Weeks

• Average Overall Relief of Constipation Score

  Week 2, Week 3, Week 4

Study Arms (2)

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.

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.

Device: Sham Squatting Assist Device

Interventions

Squatting Assist Device 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.

Also known as: Squatty Potty

Squatting Assist Device

Sham Squatting Assist Device 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.

Sham Squatting Assist Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Adil Bharucha, M.B.B.S., M.D.
• Organization: Mayo Clinic

bharucha.adil@mayo.edu

507-266-6931

Study Officials

• Adil E Bharucha, MBBS, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: September 1, 2016
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 28, 2026
• Results First Posted: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)