Using a squatting assist device to help patients with constipation

Use of a Squatting Assist Device in Patients with Constipation

This study tests if using a special squatting device can help people with constipation feel better and improve their bowel movements.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT02877394 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a squatting assist device in improving bowel symptoms and anorectal functions in patients suffering from constipation. Participants will be randomly assigned to use either a regular squatting device or a sham device to assess the impact on their symptoms. The study is based on the hypothesis that a squatting posture may facilitate better bowel evacuation compared to traditional sitting. The primary focus is on patients who meet specific criteria for functional constipation as defined by the Rome III criteria.

Who should consider this trial

Good fit: Ideal candidates are adults who meet the Rome III criteria for functional constipation and can communicate effectively with the study team.

Not a fit: Patients currently using opioid analgesics or those who do not meet the criteria for functional constipation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a simple and effective non-pharmacological solution for patients suffering from constipation.

How similar studies have performed: Previous uncontrolled studies have suggested that squatting may improve bowel symptoms, indicating potential success for this approach.

Eligibility 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.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Adil E Bharucha, MBBS, MD — Mayo Clinic
• Study coordinator: Kelly J Feuerhak

Conditions Constipation