A Study of the Use of a Squatting Assist Device in Patients with Constipation

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-004548
    NCT ID: NCT02877394
    Sponsor Protocol Number: 16-004548

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 One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. The purpose of this study is to evaluate the benefits of a footstool on symptoms and anorectal function in constipated patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study
  • Meets 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
    • < 3 SBMs/week 
    • Hard or lumpy stools ≥ 25% of time 
    • Straining ≥ 25% of time 
    • Sense of incomplete evacuation ≥ 25% of time 
    • Feeling of anorectal blockage ≥ 25% of time 
    • 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
    • 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)
    • Use of low dose tricyclic antidepressants (nortriptyline up to 50 mg/day or amitriptyline up to 25 mg/day ) will be eligible provided no increase in dose during the study period
    • Higher doses or other anticholinergics are eligible if can discontinue medication at least 3 days (72 hrs) before the date of screening and 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 will be eligible if 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Adil Bharucha, M.B.B.S., M.D.

Open for enrollment

Contact information:

Kelly Feuerhak CCRP

(507)255-6802

Feuerhak.Kelly@mayo.edu

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CLS-20308686

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