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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 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
- 否
入选标准
- •Enrollment:
- •All patients,18-81 year old, undergoing an outpatient midurethral sling surgery will be screened for participation in the study at the preoperative visit.
排除标准
- •Women undergoing concomitant urinary tract or pelvic reconstructive procedures
- •Women with pelvic organ prolapse beyond the hymen
- •Women who have undergone a different or same procedure for urinary incontinence in the past
- •Women with neurological conditions, such as multiple sclerosis, spinal cord injury/pathology
- •Cases complicated by a cystotomy or other complication necessitating postoperative catheterization
- •Non-English speakers
研究组 & 干预措施
Standard Voiding Trial
Subjects in this group will undergo backfill-assisted voiding trial that involves infusing 300ml of fluid in the bladder, removing the catheter and allowing the patient to void. All subjects will be asked to use visual analog scale (VAS) to assess their force of stream (FOS) and the voided amount as well as post-void residual (PVR) (measured by the bladder ultrasound) will be measured and recorded. Subjects will be discharged without a catheter if the voided amount is more than 200ml, or 2/3rds of the infused volume (300ml).
干预措施: Urinary voiding assessment after midurethral sling (Other)
Force of Stream Voiding Trial
Subjects in this group will undergo backfill-assisted voiding trial that involves infusing 300ml of fluid in the bladder, removing the catheter and allowing the patient to void. All subjects will be asked to use visual analog scale (VAS) to assess their force of stream (FOS) and the voided amount as well as post-void residual (PVR) (measured by the bladder ultrasound) will be measured and recorded. Subjects in the FOS group will be discharged home without a catheter if they are able to void any amount and report an FOS of at least 50% their typical FOS based on a visual analog scale
干预措施: Urinary voiding assessment after midurethral sling (Other)
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
- 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)
- Effectiveness of the sling procedure(6 weeks)
- Postoperative pain(6 weeks)
- Patient's expectation of postoperative recovery(Assessed at enrollment, average 10 minutes)
- Daily function postoperatively as well as satisfaction with the surgery(6 weeks)