A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time to regain normal bladder function
研究概览
简要总结
A randomized controlled trial of two different regimens of intermittent catheterization in women with overt postpartum urinary retention.
Participants will be randomized to one of two groups with different cut-offs for accepted postvoid residual urine (150 ml vs 250 ml).
Primary endpoint is be the time to regain normal bladder function in each group. Secondary endpoints are 1) presence/absence of bacteriuria or urinary tract infections, 2) the duration of hospital stay, 3) scores on the adapted version of the German pelvic floor questionnaire section about bladder function and postpartum symptoms.
The calculated sample size is 96 (48 in each group).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed overt postpartum urinary retention.
- •Age ≥ 18 years at delivery date.
- •Delivery at study site.
- •signed informed consent.
排除标准
- •Refusal to participate.
- •Language barrier.
研究组 & 干预措施
Women with postvoid residual volume cut-off at 150 ml
干预措施: Intermittent catheterization (Procedure)
Women with postvoid residual volume cut-off at 250 ml
干预措施: Intermittent catheterization (Procedure)
结局指标
主要结局
Time to regain normal bladder function
时间窗: 3 months
The time until bladder function returned to normal.
次要结局
未报告次要终点
研究者
Soren Lange
Fellow, Principal Investigator, M.D.
Medical University of Vienna