A Randomized Control Trial Assessing Pyridium for Post-Sling Urinary Retention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Number of Participants Considered to Have Passed Their Voiding Trial
研究概览
简要总结
There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.
详细描述
This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery
排除标准
- •Patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring indwelling catheter
- •Acute bleeding requiring indwelling catheter for accurate urine output calculation
- •Patients undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid residual >150cc, or spinal anesthesia
- •Women who are pregnant, including women of childbearing age who test positive on preoperative urine pregnancy test
研究组 & 干预措施
Pyridium arm
Phenazopyridine 200mg tablet, once prior to surgery
干预措施: Phenazopyridine (Drug)
结局指标
主要结局
Number of Participants Considered to Have Passed Their Voiding Trial
时间窗: Day 1
Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Incidence of Urinary Retention
时间窗: Day 1
Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
次要结局
- Pain Scale(Day 1: 6-8 hours after surgery)
研究者
Annacecilia Peacher
Associate Professor
Icahn School of Medicine at Mount Sinai