Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Intensity Focused Electromagnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Fecal Incontinence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study
Overview
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.
Interventions
- Device High Intensity Focused Electromagnetic Stimulation
Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
- Determine change in fecal incontinence, as determined by change in Wexner scale from baseline [Time frame: baseline, 1 and 3 months]
- Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI [Time frame: baseline, 1 and 3 months]
- Determine if change in pelvic organ dysfunction as determined by IPSS [Time frame: baseline, 1 month and 3 months]
- Determine if change in pelvic organ dysfunction as determined by CRAD- 9 [Time frame: baseline, 1 month and 3 months]
- Determine if change in pelvic organ dysfunction as determined by UD16 [Time frame: Baseline, 1 month and 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT07034443 · STUDY00003888