Footstool in Alleviating Symptoms of Evacuation Disorder (FASED)

FASED: Footstool in Alleviating Symptoms of Evacuation Disorder

The purpose of this research study is to compare the use of footstools of 2 different heights in patients with symptoms of pelvic floor dysfunction such as straining excessively during bowel movements and a sense of incomplete emptying. We are testing these footstools to see if using a footstool can improve these symptoms. Participants who enroll will be randomly assigned to either a 7 or 9 inch footstool. They will use the footstool for 8 weeks. During this time they will complete some online surveys about their bowel symptoms.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Constipation; Pelvic Floor Dysfunc
• Intervention / Treatment: Device: 7 inch Footstool for bowel movements; Device: 9 inch Footstool for bowel movements

Detailed Description

Pelvic floor dysfunction is a very common problem. The prevalence of this problem is estimated to be about 16 per 100,000 person years. In one study, 52% of patients with delayed gastric emptying and symptoms of nausea and vomiting had an evacuation disorder. In this condition, there is either impaired relaxation of the pelvic floor muscles or weakness of the pelvic floor muscles. This combined usually with impaired ability to sense presence of and quantity of stool and gas in the rectum leads to difficulty evacuating stool and gas. Characteristically, these patients have difficulty emptying stool even when its soft and pasty. Some of them can only feel empty when their stools are watery. However, diarrhea comes with its inherent risks of accidental bowel leakage.

The management of pelvic floor disorders is primarily pelvic floor biofeedback therapy. The purpose is to correct the abnormal physiology to help improve emptying. Additional therapies include use of stimulant suppositories and enemas and use of foot stool. The premise behind use of a foot stool is that is helps relax the pelvic floor muscle. While there are several companies making footstools, there is surprisingly very sparse literature supporting their use.

The purpose of this research study is to investigate whether using a footstool could improve bowel symptoms in patients who experience symptoms of pelvic floor dysfunction. Participants who are eligible and enroll will complete a 2 week baseline bowel diary followed by an 8 week period during which they will be asked to use a footstool provided to them. They will be randomly assigned either to a 7 or a 9 inch footstool. During this period they will also complete surveys about their bowel symptoms.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age 18 years or older Able to understand, read, and write English

Evidence of pelvic floor dysfunction based on at least one of the following:

Symptoms of excessive straining during bowel movements, feeling of incomplete evacuation, or need for digital evacuation of stool more than 25% of the time Abnormal anorectal manometry Abnormal balloon expulsion test Abnormal magnetic resonance imaging (MRI) defecography or barium defecography

Exclusion Criteria:

Any physical, mental, or emotional condition that, in the opinion of the Principal Investigator, may pose a safety concern or interfere with study participation Prior use of a toilet footstool for defecation Currently pregnant, based on self-reported pregnancy status during screening Active cancer Current opioid use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 7 Inch footstool; Participants in this group receive a 7 inch footstool	Device: 7 inch Footstool for bowel movements; Use of a toilet footstool during defecation for 8 weeks. Participants in this group received a 7-inch footstool designed to elevate the feet and modify toileting posture to facilitate bowel evacuation. The intervention was performed during routine bowel movements at home.; Other Names: 7 inch
Active Comparator: 9 inch footstool; Participants in this group receive a 9 inch footstool	Device: 9 inch Footstool for bowel movements; Use of a toilet footstool during defecation for 8 weeks. Participants in this arm received a 9-inch footstool designed to elevate the feet and modify toileting posture to facilitate bowel evacuation. The intervention was performed during routine bowel movements at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Average Weekly Complete Spontaneous Bowel Movements (CSBMs)	The change in average weekly number of complete spontaneous bowel movements (CSBMs) from baseline to Week 8 will be compared between participants randomized to the 7-inch footstool and participants randomized to the 9-inch footstool. A CSBM is defined as a spontaneous bowel movement associated with a self-reported sense of complete bowel evacuation, as recorded in the daily bowel diary. Baseline values will be calculated from the 2-week pre-intervention period.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Irritable Bowel Syndrome Symptom Severity Score	Change in symptom severity from baseline to Week 8 as measured by the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). The IBS-SSS is a patient-reported outcome measure ranging from 0 to 500 points, with higher scores indicating more severe IBS symptoms (worse outcome) and lower scores indicating improvement in symptom severity.	8 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Subhankar CHAKRABORTY, MD, Ph.D., Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pelvic floor dysfunction; excessive straining; incomplete evacuation; evacuation disorder; footstool
• Other Study ID Numbers: 2022H0334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to privacy concerns, we are not sharing individual level participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No