Use of a Squatting Assist Device in Patients With Constipation

• ClinicalTrials.gov Identifier: NCT02877394
• Recruitment Status: Recruiting
• First Posted: August 24, 2016
• Last Update Posted: September 28, 2022
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Adil Bharucha, MBBS, MD, Mayo Clinic

Study Description

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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants.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

Condition or disease	Intervention/treatment	Phase
Constipation	Device: Squatting Assist Device; Device: Sham Squatting Assist Device	Phase 2

Study Design

• 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

Arms and Interventions

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 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Kelly J Feuerhak; 507-255-6802; Feuerhak.Kelly@mayo.edu

Locations

United States, Minnesota

Mayo Clinic in Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Kelly J Feuerhak 507-255-6802 Feuerhak.Kelly@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Investigators

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

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• 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
• 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

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive