跳至主要内容
临床试验/NCT01091844
NCT01091844已完成不适用

Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年12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
50
试验地点
2
主要终点
Presence of urinary retention

研究概览

简要总结

Purpose: The purpose of this study is to determine if two different methods of performing a postoperative voiding trial are equivalent in evaluating urinary retention after gynecologic surgery.

Participants: The participants in this study will be women who have undergone gynecologic surgery at UNC-Chapel Hill.

详细描述

Subjects will be enrolled in the study when presenting to the UNC gynecology outpatient clinic for surgical preoperative evaluation. After surgery, each woman will undergo a voiding trial to assess for urinary retention after surgery. This is currently performed on all patients undergoing surgery involving prolapse or incontinence. At UNC this is usually performed by allowing the bladder to spontaneously fill, then allowing the patient to void and afterward catheterizing the patient to check a postvoid residual ("spontaneous fill" technique). In this study, we will also assess bladder emptying separately by filling the bladder retrograde through the catheter already in place with 300 mL of saline and then removing the catheter and allowing the patient to void ("retrograde-fill" technique). We will determine postvoid residual indirectly by subtracting voided volume from the 300 mL infused volume. No catheterization will be performed with this technique. Both of these techniques will be performed. The order in which the two techniques will be performed will be randomized. We will then compare the outcomes of these two techniques of voiding trials to see if they are equivalent in assessing urinary retention. Of note, the retrograde fill technique is standard at other institutions and is not considered experimental.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • Women undergoing surgical correction of pelvic organ prolapse or urinary incontinence

排除标准

  • Unwillingness to participate in the investigation.
  • Inability to give informed consent.
  • Known preoperative voiding dysfunction
  • Plan for suprapubic catheter placement at time of surgery.
  • Age less than 18
  • Non-English speaking

结局指标

主要结局

Presence of urinary retention

时间窗: Postoperative Day 1

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验

Efficacy of Retrograde Fill Vs Spontaneous Fill to... | 临床试验