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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • High Intensity Focused Electromagnetic Stimulation

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: High Intensity Focused Electromagnetic StimulationExperimental treatment 1 intervention

Trial outcomes

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

Time frame
baseline, 1 month and 3 months

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

Patient Reported Outcomes Measurement Information System Score (PROMIS) sexual function, scored 0-20 to evaluate patient sexual health. Higher score indicates better sexual function

Time frame
baseline, 1 month, 3 months
2

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

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

Time frame
baseline, 1 and 3 months
3

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

POPDI6 (Pelvic Organ Prolapse Distress Inventory). Score 0-20 with higher score reflecting more severe symptoms of pelvic organ dysfunction.

Time frame
baseline, 1 and 3 months
4

Determine if change in pelvic organ dysfunction as determined by IPSS

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

Time frame
baseline, 1 month and 3 months

Other outcomes

Sponsors and contacts

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