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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 Hill1 个研究点 分布在 1 个国家目标入组 59 人2011年11月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Urinary Retention
发起方
University of North Carolina, Chapel Hill
入组人数
59
试验地点
1
主要终点
Comparison of the proportion of subjects who passed the voiding trial between the two groups
状态
已完成
最后更新
11年前

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.

注册库
clinicaltrials.gov
开始日期
2011年11月
结束日期
2014年4月
最后更新
11年前
研究类型
Interventional
研究设计
Single Group
性别
Female

研究者

入排标准

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)

研究点 (1)

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