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 range18 Years

SexALL

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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

What they're measuring

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

Timeframe: baseline, 1 month and 3 months

Trial details

NCT IDNCT07034443

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Samara Spence, MD

6037323655 samara.spence@cshs.org