A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders

University of California, San Diego1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2007年9月最近更新: 2009年11月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of California, San Diego
入组人数: 100
试验地点: 1
主要终点: Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 21 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•surgical eligibility met by Center for the Treatment Obesity criteria
•morbid obesity (BMI > 40 kg/m2) or severe obesity (BMI > 33 kg/m2) in presence of NIH co-morbidities
•willing to participate in study, including completion of self-reported questionnaires

排除标准

•pregnancy or planned pregnancy
•recent pregnancy or pelvic surgery
•age < 21 years
•known neurologic disease or pelvic pathology

结局指标

主要结局

Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire

时间窗: 12 months

次要结局

Weekly incontinence episodes and pad use ascertained by incontinence diary(12 months)
Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I)(12 months)
Sexual function ascertained by validated measure (PISQ)(12 months)

研究者

发起方

University of California, San Diego

申办方类型

Other

研究点 (1)

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