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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks
Cedars Sinai Medical Center
Los Angeles, California, United States
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
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
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
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
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
Determine if change in pelvic organ dysfunction as determined by CRAD- 9
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CRAD-8 (Colorectal Anal Distress Inventory 8 ). Higher scores indicate more severity in pelvic organ dysfunction.
Time frame: baseline, 1 month and 3 months
Determine if change in pelvic organ dysfunction as determined by UD16
UDI6 (Urinary Distress Inventory 6). Score 0-20, higher number indicated more severe symptoms of dysfunction
Time frame: Baseline, 1 month and 3 months