Footstool in Alleviating Symptoms of Evacuation Disorder

NCT07709078 | Active Not Recruiting

• 1 other identifier: 2022H0334
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Floor Dysfunc; Chronic Constipation

Keywords

pelvic floor dysfunction; incomplete evacuation; excessive straining; evacuation disorder; footstool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Irritable Bowel Syndrome Symptom Severity Score

  8 weeks

Study Arms (2)

7 Inch footstool

ACTIVE COMPARATOR

Participants in this group receive a 7 inch footstool

Device: 7 inch Footstool for bowel movements

9 inch footstool

ACTIVE COMPARATOR

Participants in this group receive a 9 inch footstool

Device: 9 inch Footstool for bowel movements

Interventions

7 inch Footstool for bowel movements DEVICE

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.

Also known as: 7 inch

7 Inch footstool

9 inch Footstool for bowel movements DEVICE

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.

9 inch footstool

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Subhankar CHAKRABORTY, MD, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment: After a 2-week baseline assessment period, eligible participants were randomized to one of two intervention arms: a 7-inch footstool or a 9-inch footstool. Participants used the assigned footstool during bowel movements for 8 weeks while completing daily bowel diaries and weekly symptom questionnaires. Outcomes were compared between the two parallel groups and relative to baseline measures.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: December 27, 2022
• Primary Completion: July 11, 2026
• Study Completion: July 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)