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 volunteersQualifiers
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
Single group
Treatments tested in this trial
High Intensity Focused Electromagnetic Stimulation
DevicePatients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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.
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
Sponsors and contacts
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