Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of trial of void parameters
研究概览
简要总结
Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.
详细描述
Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume [MVV], post-void residual via bladder scanner [PVR], subjective force of urinary stream [sFOS]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •English-speaking women, age >18yo
- •Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.
排除标准
- •Unable or unwilling to perform self-catheterizatoin either by patient or willing family member
- •Pre-existing voiding dysfunction defined as documented PVR > 200 mL
- •Intraoperative urinary tract injury needing indwelling catheter on discharge
- •Need for overnight admission
研究组 & 干预措施
PVR-based home self-catheterization
Patients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void.
干预措施: PVR-based self-catheterization (Procedure)
结局指标
主要结局
Diagnostic accuracy of trial of void parameters
时间窗: First void postoperative (within 4 hours postop)
Comparison of sensitivity, specificity, positive/negative predictive value of different trial of void parameters from first postoperative void, based on those used in the literature.
Incidence of post-operative urinary retention
时间窗: 24-72 hours postoperative
Based on defined criteria
次要结局
- Patient satisfaction with self-catheterization method via questionnaire(2 weeks postoperative)
- Time to first void postoperative(4 hours postoperative)
- Rate of post-operative and post-discharge urinary retention(24-72 hours postoperative)
- Rate of post-operative urinary tract infection(6 weeks postoperative)
研究者
Anne Cooper, MD
Assistant Professor of Urogynecology
Dartmouth-Hitchcock Medical Center