跳至主要内容
临床试验/NCT04557852
NCT04557852已完成不适用

Clinical Outcome and Urodynamic Changes of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse: a Mid-term Follow-up With a Median Duration of 30 Months

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2011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
160
试验地点
1
主要终点
Voiding difficulty

研究概览

简要总结

Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the changes in values of urodynamic parameters between baseline and after pelvic organ prolapse surgery.

详细描述

Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery (ATVM) but without concomitant mid-urethral sling surgery were reviewed. Data of pre- and post-operative lower urinary tract symptoms and urodynamic parameters were compared. The bladder outlet obstruction was defined when the detrusor pressure at maximum flow rate was not less than 40cmH2O, and the maximum flow rate was less than 12 mL/s. Overactive bladder syndrome, detrusor overactivity, bladder oversensitivity and urodynamic stress incontinence were also recognized as international continence society definition. 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 as statistically significant.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Women with pelvic organ prolapse
  • Women received anterior transvaginal mesh surgery

排除标准

  • Concomitant mid-urethral sling surgery
  • Chronic urinary tract infection
  • Interstitial cystitis
  • Malignancy history in pelvic organ
  • Ever received pelvic radiation
  • Concomitant transabdominal surgery

结局指标

主要结局

Voiding difficulty

时间窗: November 2011 to December 2015

Weak stream of urination, intermittency, strain to void or incomplete empty sensation after the anterior transvaginal mesh surgery

次要结局

  • Overactive bladder syndrome(November 2011 to December 2015)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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