Fecal Incontinence
Conditions
Keywords
Ulcerative colitis, Fecal Incontinence, Functional Outcomes, High Intensity Focused Electromagnetic Stimulation, J pouch
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.
Interventions
DEVICEHigh Intensity Focused Electromagnetic Stimulation
Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 UD16 | Baseline, 1 month and 3 months | UDI6 (Urinary Distress Inventory 6). Score 0-20, higher number indicated more severe symptoms of dysfunction |
Countries
United States
Contacts
CONTACTSamara Spence, MD
CONTACTGayane Ovespyan, MPH
PRINCIPAL_INVESTIGATORKaren Zaghiyan, MD
Cedar Sinai Medical Center
Outcome results
None listed