Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High Intensity Focused Electromagnetic Stimulation
This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation
干预措施: High Intensity Focused Electromagnetic Stimulation (Device)
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)
- Determine change in fecal incontinence, as determined by change in Wexner scale from baseline(baseline, 1 and 3 months)
- Determine if change in pelvic organ dysfunction as determined by IPSS, CRAD- 9, UD16, POPDI(baseline, 1 and 3 months)
- Determine if change in pelvic organ dysfunction as determined by IPSS(baseline, 1 month and 3 months)
- Determine if change in pelvic organ dysfunction as determined by CRAD- 9(baseline, 1 month and 3 months)
- Determine if change in pelvic organ dysfunction as determined by UD16(Baseline, 1 month and 3 months)
研究者
Karen Zaghiyan
Colon and Rectal Surgeon
Cedars-Sinai Medical Center