A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- difference in acute voiding dysfunction between a backfill assisted voiding trial
研究概览
简要总结
Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events
详细描述
Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The voiding trial instructions for each specific patient will be given to the Post Anesthesia Care Unit (P(ACU) or floor Registered Nurse (RN) taking care of the patient and will include what volume voided equals a passing voiding trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery
排除标准
- •Patients undergoing fistula repair or sacral neuromodulation
- •Voiding dysfunction preoperatively that requires intermittent self-catheterization
- •Intraoperative bladder injury
- •Pregnancy
- •Preoperative UTI (culture proven within 7 days prior to surgery)
结局指标
主要结局
difference in acute voiding dysfunction between a backfill assisted voiding trial
时间窗: Week 6
difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)
次要结局
- proportion of patients develops postoperative UTIs(Day 7)
- proportion of patients requiring repeat outpatient voiding trials(Week 6)
- proportion of patients developing bladder pain or pressure(Week 6)
- proportion of patients developing overactive bladder symptoms(Week 6)
- average number of days postoperatively, that require catheterization(Week 6)