跳至主要内容
临床试验/NCT03509038
NCT03509038Unknown不适用

Urodynamic Evaluation of Incontinent Obese Women Before and After Weight Reduction by Bariatric Surgery : What Urodynamic Healing Factors? BUDI (Bariatric UroDynamic Improvement)

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年3月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Urodynamic changes after bariatric surgery in obese incontinent women

研究概览

简要总结

In the population of obese women, the prevalence of urinary incontinence (UI) is around 70%. It was shown in the literature that weight loss by bariatric surgery allowed a significant improvement in the symptoms and impact on the quality of life of the IU. However, no prognostic factor for recovery has yet been identified and the pathophysiological mechanisms underpinning this improvement are not fully elucidated.

The main objective of this study is to highlight the urodynamic changes associated with the improvement of the symptom and quality of life scores in a population of incontinent obese women before and after bariatric surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • The research protocol will be proposed to all patients requiring bariatric surgery (gastric bypass or sleeve gastrectomy) and describing urinary incontinence according to the definition of the International Continence Society (ICS)

排除标准

  • minors under the age of 18
  • pregnant or lactating women
  • women not speaking French (important to understand and respond to questionnaires)
  • women who have not given their written consent
  • neurological diseases,
  • patients who have benefited from urinary incontinence surgery, prolapse treatment or pelvic surgery at risk of urodynamic modifications (extensive resection of deep endometriosis, pelvic wound surgery, pelvic radiation therapy).

结局指标

主要结局

Urodynamic changes after bariatric surgery in obese incontinent women

时间窗: 24 months

to highlight the changes in urodynamic vesical pressure (cmH2O) associated with the improvement of urinary incontinence after bariatric surgery

次要结局

  • Urinary incontinence symptom improvement after bariatric surgery(24 months)
  • Quality of life improvement after bariatric surgery(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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