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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 Inch footstool | Active Comparator | Participants in this group receive a 7 inch footstool |
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| 9 inch footstool | Active Comparator | Participants in this group receive a 9 inch footstool |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Spontaneous Bowel Movements | We will calculate the change in number of complete spontaneous bowel movements (CSBMs) after 8 weeks of footstool use compared to that during the 2 week baseline period. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IBS Symptom Severity | We will compare the change in IBS symptom severity after 8 weeks of footstool use compared to that at baseline using the IBS-SSS questionnaire | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- 1. Any physical, mental or emotional problem that the Principal investigator considers as potential safety concern.
2. Prior use of a foot stool 3. Currently pregnant - based on self-reported pregnancy status on screening questionnairera 4. Active cancer 5. Current use of opioids
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| Name | Affiliation | Role |
|---|---|---|
| Subhankar CHAKRABORTY, MD, Ph.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
Due to privacy concerns, we are not sharing individual level participant data with other researchers.
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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.
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| 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. |
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