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临床试验/NCT04184128
NCT04184128已完成不适用

Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele and Changes of Voiding Function After Cystocele

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 623 人开始时间: 2010年11月1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
623
试验地点
1
主要终点
DU or BOO

研究概览

简要总结

Women with cystocele may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). However, the impact of cystocele repair on the rates of DU and BOO remained obscure. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the impact of cystocele repair on the rates of DU and BOO.

详细描述

Between November 2010 and September 2018, all women with ≥ POP-Q stage II cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate (Qmax), voided volume, post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were excluded from this study. The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. Wilcoxon signed-rank test or McNemar's test was used for statistical analysis as appropriate. P < 0.05 was considered statistically significant.

研究设计

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

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ POP-Q stage II cystocele

排除标准

  • Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.

结局指标

主要结局

DU or BOO

时间窗: Between November 2010 and September 2018

The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 % \[1\]. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s \[1\]. BVE = voided volume / (voided volume+ PVR) x 100%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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