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临床试验/NCT04416152
NCT04416152招募中不适用

Impact of Female Pelvic Reconstruction Surgery on Lower Urinary Tract Symptoms, Psychosomatic Distress and Sexual Function

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
the women's bladder function questionnaire of UDI-6

研究概览

简要总结

To get the impact of pelvic floor reconstruction surgery on lower urinary tract symptoms, psychological distress and sexual function.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

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

入选标准

  • Women with pelvic organ prolapse, who will undergo pelvic reconstruction surgery
  • Women who had undergone pelvic reconstruction surgeries in our hospital

排除标准

  • Pregnant woman.

结局指标

主要结局

the women's bladder function questionnaire of UDI-6

时间窗: 10 years

Change of UDI-6 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.

Change of psychosomatic score

时间窗: 1 year

Change of psychosomatic score between baseline and after pelvic reconstruction surgery, and higher scores mean a or worse outcome.

Change of Overactive Bladder Symptom Score

时间窗: 1 year

Change of OABSS score between baseline and after pelvic reconstruction surgery. Score values 0-15, and higher scores mean a or worse outcome.

the women's bladder function questionnaire of IIQ-7

时间窗: 10 years

Change of IIQ-7 score between baseline and after pelvic reconstruction surgery. Score values 0-18, and higher scores mean a or worse outcome.

Change of FSFI score

时间窗: 1 year

Change of FSFI score between baseline and after pelvic reconstruction surgery. higher scores mean a or worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

Far Eastern Memorial Hospital

研究点 (1)

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