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临床试验/NCT03607968
NCT03607968已完成不适用

Factors Affecting the Improvement of Severity of Concomitant Urodynamic Stress Incontinence After a Novel Transvaginal Mesh Surgery for Women With Pelvic Organ Prolapse

National Taiwan University Hospital0 个研究点目标入组 134 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
134
主要终点
Improvement of urodynamic stress incontinence

研究概览

简要总结

Background/Purpose:

A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Patients and Methods:

All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline [i.e., 100 * (postoperative pad weight - baseline pad weight)/baseline pad weight].

Expected Results:

The investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Key Words: pelvic organ prolapse, stress urinary incontinence, pad test, urodynamic stress incontinence

详细描述

Background/Purpose:

A novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.

Methods:

All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries between November 2011 and December 2015 at the Department of Obstetrics & Gynecology, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline [i.e., 100 * (postoperative pad weight - baseline pad weight)/baseline pad weight].

Expected Results:

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with pelvic organ prolapse and concomitant overt or occult urodynamic stress incontinence
  • Received the novel anterior transvaginal mesh surgery.

排除标准

  • Pregnant women, prepare for pregnancy or younger than 20-year-old
  • Significant severe urinary urgency
  • Mixed urinary incontinence with dominant urgency incontinence
  • Regular urethral catheterization or intermittent self-catheterization
  • Urinary tract infection (UTI) or chronic inflammation in recent 2 weeks before operation
  • Bladder calculus
  • A history of pelvic radiotherapy
  • Preexisting malignant pelvic tumors.

结局指标

主要结局

Improvement of urodynamic stress incontinence

时间窗: 2011/11/01-2015/12/31

Preoperative and postoperative urodynamic studies to detect USI

次要结局

  • Improvement of stress urinary incontinence(2011/11/01-2015/12/31)

研究者

申办方类型
Other
责任方
Sponsor

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