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临床试验/NCT02739256
NCT02739256终止不适用

Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
57
试验地点
2
主要终点
time to return of normal bladder function

研究概览

简要总结

The primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

详细描述

Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux.

This study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • surgical management of pelvic organ prolapse requiring an overnight hospital admission

排除标准

  • same day surgery
  • non-ambulatory (allowed to use an assistive device)
  • inability to provide informed consent, age < 21 years
  • pregnancy or desire for future pregnancy
  • systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)
  • known preoperative urinary retention (defined as a post-void residual > 100mL)
  • an untreated urinary tract infection at the time of surgery
  • treatment at the time of surgery for urinary tract infection
  • symptoms of urinary tract infection on the day of surgery

结局指标

主要结局

time to return of normal bladder function

时间窗: 5 days

次要结局

  • time to first ambulation(24 hours)
  • patient preference in the timing of the voiding trial(24 hours)
  • anxiety level(24 hours)
  • pain level(24 hours)
  • catheter associated urinary tract infections(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charelle Carter-Brooks

Principal Investigator

University of Pittsburgh

研究点 (2)

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