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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Focused Electromagnetic Stimulation | Experimental | This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Focused Electromagnetic Stimulation | Device | Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 1 month and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 1 month, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samara Spence, MD | Contact | 6037323655 | samara.spence@cshs.org | |
| Gayane Ovespyan, MPH | Contact | 3102899224 | gayane.ovespyan@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Karen Zaghiyan, MD | Cedar Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
PI preference
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2025 | Jun 17, 2025 |
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| 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 | 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. | 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 | baseline, 1 month and 3 months |
| Determine if change in pelvic organ dysfunction as determined by CRAD- 9 | CRAD-8 (Colorectal Anal Distress Inventory 8 ). Higher scores indicate more severity in pelvic organ dysfunction. | 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 | Baseline, 1 month and 3 months |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2025 | Jun 17, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
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