Pelvic Floor DysfuncFASEDNCT07709078
Footstool in Alleviating Symptoms of Evacuation Disorder
A study testing 7 inch Footstool for bowel movements and 9 inch Footstool for bowel movements in people with Pelvic Floor Dysfunc and Chronic Constipation, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Floor Dysfunc, Chronic Constipation
- What is being tested?
- 7 inch Footstool for bowel movements and 9 inch Footstool for bowel movements
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Floor Dysfunc, Chronic Constipation
- Being tested
- 7 inch Footstool for bowel movements, 9 inch Footstool for bowel movements
- Keywords
- pelvic floor dysfunction, incomplete evacuation, excessive straining, evacuation disorder, footstool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 inch Footstool for bowel movementsDevice
Also called 7 inch
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.
9 inch Footstool for bowel movementsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 7 Inch footstool | Active comparator | Participants in this group receive a 7 inch footstool Receives: Device: 7 inch Footstool for bowel movements |
| 9 inch footstool | Active comparator | Participants in this group receive a 9 inch footstool Receives: Device: 9 inch Footstool for bowel movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start27 Dec 2022
- Primary completion11 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DysfuncStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subhankar CHAKRABORTY, MD, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709078
- Sponsor's protocol ID
- 2022H0334
- Acronym
- FASED
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy concerns, we are not sharing individual level participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FASED: Footstool in Alleviating Symptoms of Evacuation Disorder
- ClinicalTrials.gov ID
- NCT07709078
- Acronym / sponsor ID
- FASED / 2022H0334
- Conditions
- Pelvic Floor Dysfunc, Chronic Constipation
- Keywords
- pelvic floor dysfunction, incomplete evacuation, excessive straining, evacuation disorder, footstool
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 11 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 7 Inch footstool | Active comparator | Device: 7 inch Footstool for bowel movementsParticipants in this group receive a 7 inch footstool |
| 9 inch footstool | Active comparator | Device: 9 inch Footstool for bowel movementsParticipants in this group receive a 9 inch footstool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older Able to understand, read, and write English
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 inch Footstool for bowel movementsAlso: 7 inchUse 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. | Device | 7 Inch footstool |
| 9 inch Footstool for bowel movementsUse 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. | Device | 9 inch footstool |
Primary outcome
Change in Average Weekly Complete Spontaneous Bowel Movements (CSBMs)
Time frame: 8 weeks
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.
1 secondary outcome
Change in Irritable Bowel Syndrome Symptom Severity Score
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. Due to privacy concerns, we are not sharing individual level participant data with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhankar CHAKRABORTY, MD, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 inch Footstool for bowel movements and 9 inch Footstool for bowel movements in people with Pelvic Floor Dysfunc and Chronic Constipation, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Weekly Complete Spontaneous Bowel Movements (CSBMs) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.