跳至主要内容
临床试验/NCT01343784
NCT01343784已完成不适用

Assessment of Voiding After Sling (AVAS): A Randomized Trial of Two Methods of Post-operative Catheter Management After Midurethral Sling for Female Stress Urinary Incontinence

The Cleveland Clinic4 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2011年4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
105
试验地点
4
主要终点
Total Catheterization Rate

研究概览

简要总结

The purpose of this study is to compare the incidence of catheterization from discharge to 6 weeks postoperatively when using two methods of post-operative voiding evaluation after a mid-urethral sling procedure. The investigators' results may lead to a decreased use of indwelling catheters and their associated morbidity after outpatient sling surgery.

详细描述

Minimally invasive slings have demonstrated similar efficacy to earlier abdominal anti-incontinence procedures, but offer the benefit of shorter operating times, less voiding dysfunction, lower morbidity and are usually done as an outpatient procedure. Despite the advantages, about 35% of patients are discharged home with indwelling catheters. Indwelling catheters are bothersome for patients, costly to the healthcare system and are a source of significant morbidity. The challenge for pelvic surgeons performing anti-incontinence procedures is avoiding postoperative urinary retention while minimizing the use of catheters and their associated risks. A commonly described backfill-assisted voiding trial is used as a means of evaluating bladder function postoperatively. This method uses a low post-void residual as a specific criterion for discharge without a catheter. However, the validity of this method has never been critically evaluated. Our recent observational study suggests that patients may be safely discharged without a catheter after a midurethral sling procedure based on their subjective assessment of the force of stream. Our proposed study expands on this pilot data using a randomized trial to evaluate two methods of post-operative voiding evaluation. The results may lead to a decreased use of indwelling catheters and their associated morbidity after outpatient sling surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Total Catheterization Rate

时间窗: Surgery to 6-weeks post-operatively

The incidence of postoperative catheterization (total catheterization) at any point from discharge after surgery to 6 weeks postoperatively. The incidence of being discharged with an indwelling catheter will be gathered from PACU records. The information regarding catheterization after that point will be captured via the electronic medical records or patient questionnaires (at 2 days, 1 week, and 6 week follow-up).

次要结局

  • Postoperative pain(6 weeks)
  • Subjective assessment of Force of Stream (FOS).(30 minutes to 2 hours in recovery room)
  • Number of return visits to the office or to the emergency room(6 weeks)
  • Cumulative number of days of catheterization(6 weeks)
  • Incidence of catheter acquired urinary tract infection (CAUTI)(6 weeks)
  • Time to discharge from PACU(30 minutes to 2 hours in recovery room)
  • Patient's expectation of postoperative recovery(Assessed at enrollment, average 10 minutes)
  • Effectiveness of the sling procedure(6 weeks)
  • Daily function postoperatively as well as satisfaction with the surgery(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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