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NCT Number: NCT07034443

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

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.

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Key information

Conditions

Fecal Incontinence Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Focused Electromagnetic Stimulation

Device

Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks

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

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: baseline, 1 and 3 months

    The Wexner Scale ranges from 0-20, with 0 being perfect continence and 20 being complete incontinence

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

    Time frame: 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.

  4. Determine if change in pelvic organ dysfunction as determined by IPSS

    Time frame: baseline, 1 month and 3 months

    IPSS (International Prostate Symptom Score). Scored 0-20. Higher score indicates more severe symptoms of prostate dysfunction

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

    Time frame: baseline, 1 month and 3 months

    CRAD-8 (Colorectal Anal Distress Inventory 8 ). Higher scores indicate more severity in pelvic organ dysfunction.

  6. Determine if change in pelvic organ dysfunction as determined by UD16

    Time frame: Baseline, 1 month and 3 months

    UDI6 (Urinary Distress Inventory 6). Score 0-20, higher number indicated more severe symptoms of dysfunction

Study contacts

Contact information is provided by the study sponsor or research team.

Gayane Ovespyan, MPH

CONTACT

[email protected]

3102899224

Samara Spence, MD

CONTACT

[email protected]

6037323655

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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