Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation

Purpose

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.

Condition

  • Fecal Incontinence

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High Intensity Focused Electromagnetic Stimulation
This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation
  • Device: High Intensity Focused Electromagnetic Stimulation
    Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks

Recruiting Locations

Cedars Sinai Medical Center
Los Angeles, California 90048
Contact:
Karen Zaghiyan, MD
3102899224
karen.zaghiyan@cshs.org

More Details

Status
Recruiting
Sponsor
Cedars-Sinai Medical Center

Study Contact

Samara Spence, MD
6037323655
samara.spence@cshs.org