Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With… (NCT07034443) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
United States20 participantsStarted 2025-07-01
Plain-language summary
The purpose of this research is to evaluate functional outcomes in patients with Ulcerative Colitis and IBDU who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J pouch, after treatment with the Emsella chair. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals 18 years old or older are included.
* Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU
* Must be at least 1 year out from J pouch surgery
* Have fecal incontinence
Exclusion Criteria:
* Any records flagged "break the glass" or "research opt out."
* Pediatric Patients \<18 years of age
* Did not receive a J pouch
* Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis
* Have active pouchitis
* Have an active fistula
* If reclassified to de novo Crohn's after surgery
* Have implanted metal devices or medical devices
* Pregnant patients
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine if patients have change in overall quality of live, as determined by statistically significant change in Patient Reported Outcomes Measurement Information System 10 Score from baseline