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临床试验/NCT02150083
NCT02150083已完成不适用

Diagnostic Accuracy of Two Techniques for Assessing Postoperative Voiding Function - A Randomized Trial

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Comparison of the proportion of subjects who passed the voiding trial between the two groups

研究概览

简要总结

Stress urinary incontinence (SUI) is a common condition that affects up to 35% of women. Many surgical procedures have been developed to treat SUI, and midurethral slings have gradually become the first line treatment. Voiding dysfunction, or inability for a patient to empty her bladder, immediately after surgery is common. A bladder test is often performed in the recovery area to see if the patient is able to empty her bladder. This typically consists of filling the bladder with 300 mL of saline through the foley catheter. The catheter is then removed and the patient is asked to void. The investigators then measure the voided volume and the residual left inside the bladder to determine if she is able to empty her bladder sufficiently or not. A successful voiding trial is defined as voiding 2/3 of the total volume in the bladder and having less than 100 mL left inside the bladder as residual. Our goal of this study was to evaluate efficiency and effectiveness of a retrograde postoperative voiding trial that is initiated in the operating room. Our hypothesis was that a retrograde postoperative voiding trial initiated in the operating room would be as effective as a standard retrograde postoperative voiding trial to predict postoperative voiding dysfunction while allowing for patients to spend less time in the recovery unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • English-speaking
  • Women over the age of 18
  • Patients with stress urinary incontinence planning to undergo midurethral sling placement

排除标准

  • Prior incontinence surgery
  • Concomitant surgery for pelvic organ prolapse except for anterior repair
  • Intraoperative cystotomy
  • Patients taking anticholinergic medication

结局指标

主要结局

Comparison of the proportion of subjects who passed the voiding trial between the two groups

时间窗: Close of incision until discharge, approximately 3 hours.

Group 1 - retrograde bladder fill in operating room Group 2 - retrograde bladder fill in post-anesthesia care unit

次要结局

  • Comparison of length of stay in post-anesthesia care unit between the two groups(Close of incision until discharge, approximately 3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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