Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.
研究概览
简要总结
A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR.
详细描述
The purpose of the study is to compare clinical outcomes of women with bladder distension injuries due to postpartum urinary retention (PUR) who have varying duration of catheterization for initial treatment of postpartum urinary retention.
Hypotheses
- Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention.
Definition of resolution of postpartum voiding dysfunction:
A. A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week 2. The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence. 3. Risk factors for PUR will be related to intrapartum and delivery conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking.
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
- •Age greater than or equal to
- •Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
- •English or Spanish speaking and reading.
排除标准
- •Adults unable to consent.
- •Women under the age of
- •Women who are currently pregnant (All women in the study will have already delivered).
- •Prisoners or detained individuals.
- •Women who chronically use a urinary catheter for another medical condition.
- •Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy).
- •Women with preeclampsia requiring magnesium treatment for seizure prevention.
- •Women with prior PUR
- •Women on anticholinergic medications.
- •Women who are actively being treated for a UTI.
结局指标
主要结局
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Sarah Collins
Assistant Professor, Department of Obstetrics & Gynecology
Northwestern University