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

Not Applicable

Not yet recruiting

• Conditions: Fecal Incontinence

• Registration Number: NCT07034443
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-16
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-07-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Patient Reported Outcomes Measurement Information System Score (PROMIS) sexual function, scored 0-20 to evaluate patient sexual health. Higher score indicates better sexual function
Determine change in fecal incontinence, as determined by change in Wexner scale from baseline	baseline, 1 and 3 months	The Wexner Scale ranges from 0-20, with 0 being perfect continence and 20 being complete incontinence
Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI	baseline, 1 and 3 months	POPDI6 (Pelvic Organ Prolapse Distress Inventory). Score 0-20 with higher score reflecting more severe symptoms of pelvic organ dysfunction.
Determine if change in pelvic organ dysfunction as determined by IPSS	baseline, 1 month and 3 months	IPSS (International Prostate Symptom Score). Scored 0-20. Higher score indicates more severe symptoms of prostate dysfunction
Determine if change in pelvic organ dysfunction as determined by CRAD- 9	baseline, 1 month and 3 months	CRAD-8 (Colorectal Anal Distress Inventory 8 ). Higher scores indicate more severity in pelvic organ dysfunction.
Determine if change in pelvic organ dysfunction as determined by UD16	Baseline, 1 month and 3 months	UDI6 (Urinary Distress Inventory 6). Score 0-20, higher number indicated more severe symptoms of dysfunction

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States