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

NCT07034443 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00003888
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fecal Incontinence

Keywords

Ulcerative colitis; Fecal Incontinence; Functional Outcomes; High Intensity Focused Electromagnetic Stimulation; J pouch

Outcome Measures

Primary Outcomes (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

  Patient Reported Outcomes Measurement Information System Score (PROMIS 10), scaled from 0-20 evaluate patient overall quality of life. Higher score indicates better health

  baseline, 1 month and 3 months

Secondary Outcomes (6)

• Determine change in sexual function and satisfaction in patients at treatment determined by Patient Reported Outcomes Measurement Information System Score sexual function scale

  baseline, 1 month, 3 months

• Determine change in fecal incontinence, as determined by change in Wexner scale from baseline

  baseline, 1 and 3 months

• Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI

  baseline, 1 and 3 months

• Determine if change in pelvic organ dysfunction as determined by IPSS

  baseline, 1 month and 3 months

• Determine if change in pelvic organ dysfunction as determined by CRAD- 9

  baseline, 1 month and 3 months

Study Arms (1)

High Intensity Focused Electromagnetic Stimulation

EXPERIMENTAL

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

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

High Intensity Focused Electromagnetic Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Colonic Diseases

Study Officials

• Karen Zaghiyan, MD

  Cedar Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samara Spence, MD

CONTACT

6037323655; samara.spence@cshs.org

Gayane Ovespyan, MPH

CONTACT

3102899224; gayane.ovespyan@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Colon and Rectal Surgeon

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 24, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)