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临床试验/NCT05312047
NCT05312047已完成不适用

Urinary Continence Status After Vaginal Surgery for Prolapse Correction.

Hospital Universitari Vall d'Hebron Research Institute14 个研究点 分布在 1 个国家目标入组 609 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
609
试验地点
14
主要终点
Stress urinary incontinence (SUI).

研究概览

简要总结

Urinary incontinence after surgical correction of pelvic organ prolapse (POP) could occur. This is a condition that decreases both patients' satisfaction and quality of life. Reports on the prevalence of urinary incontinence after POP surgery are controversial. Concomitant surgery for incontinence could reduce this prevalence, whereas it increases treatment costs and the likelihood of surgical complications. Therefore, it is of paramount importance to know the exact prevalence of urinary incontinence after POP surgery in our population and the potential risk factors associated with this condition.

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
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who will undergo vaginal surgery for pelvic organ prolapse.

排除标准

  • Inability to give consent to the study.

结局指标

主要结局

Stress urinary incontinence (SUI).

时间窗: 1 year after surgery.

A "Yes" response to any of three questions on the spanish version of the Pelvic Floor Distress Inventory (PFDI) stress incontinence subscale regarding leakage with coughing, sneezing, or laughing; physical exercise; and lifting or bending over (PFDI questions 20, 21 and 22) .

Urgency urinary incontinence (UUI).

时间窗: 1 year after surgery.

A "Yes" response to PFDI question 19, "usually experiences urine leakage associated with a feeling of urgency, that is, a strong sensation of needing to go to the bathroom".

次要结局

  • Incontinence severity(1 year after surgery.)
  • Patients' satisfaction with the procedure.(1 year after surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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