Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
Not applicable · Testing High Intensity Focused Electromagnetic Stimulation · 1 site · Cedars-Sinai Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing High Intensity Focused Electromagnetic Stimulation (a device) as a possible treatment. Condition(s) listed: Fecal Incontinence.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2026-08-01 (planned).
- Main results expected around 2027-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- 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 (baseline, 1 month and 3 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Fecal Incontinence |
| Lead sponsor | Cedars-Sinai Medical Center |
| Enrollment | 20 (estimated) |
| Start date | 2026-08-01 |
| Primary completion (est.) | 2027-07-01 |
| First posted | 2025-06-24 |
| Last updated | 2026-08-12 |
| Official title | Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study |
| ClinicalTrials.gov ID | NCT07034443 |
Interventions
- High Intensity Focused Electromagnetic Stimulation (Device)
Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.