The Impact of Tamsulosin on Duration of Post-Operative Urinary Retention in Women Undergoing Pelvic Reconstructive Surgery- A Double Blind, Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- To determine the impact of Tamsulosin on duration of urinary retention
研究概览
简要总结
The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.
详细描述
The primary objective is to determine the impact of Tamsulosin on duration of urinary retention following pelvic reconstructive surgery in women. Duration of catheterization via indwelling foley or clean intermittent self-catheterization (CISC), measured in days, will be compared between women receiving Tamsulosin versus placebo after diagnosis of postoperative urinary retention via standardized voiding trial. It is hypothesized that women receiving Tamsulosin will have a shorter duration of urinary retention, fewer urinary tract infections, and improved quality of life as compared with placebo. The Euroqol-5D (EQ-5D) will be used to compare physical, emotional, functional, and social/family well-being between women receiving Tamsulosin and placebo.
Upon diagnosis of POUR, women will be offered participation in the study. Once consent is obtained, women will be randomized to tamsulosin 0.4 mg or matching placebo capsules to be used daily until resolution of POUR or a 10 day course, whichever occurs first.
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
- Double (Participant, Care Provider)
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
- •18 years or older
- •willing and able to provide informed consent
- •postoperative urinary retention as defined by a failed RGVT prior to hospital discharge
- •Ability to speak and read English
- •Tolerate pill ingestion
排除标准
- •allergy/intolerance to Tamsulosin or sulfa drugs
- •preoperative history of urinary retention as defined by preoperative post void residual of >150mL
- •current use of alpha antagonist medication for hypertension
- •severe dementia
- •end stage renal or liver disease
- •history of severe heart failure or major cardiovascular event in the last 6 months
研究组 & 干预措施
Tamsulosin
10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention.
Both study drug and placebo will appear identical and will be prepared by the pharmacy.
干预措施: Tamsulosin (Drug)
Placebo
10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention.
Both study drug and placebo will appear identical and will be prepared by the pharmacy.
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the impact of Tamsulosin on duration of urinary retention
时间窗: Date of failed retrograde voiding trial until resolution of post-operative urinary retention or a 10-day course
The primary outcome is duration of postoperative urinary retention measured in days following failed retrograde voiding trial.
次要结局
- To assess the impact of Tamsulosin on rates of urinary tract infection (UTI).(Date of failed the retrograde voiding trial and up to 6 weeks.)
- To quantify the effect of Tamsulosin on patient quality of life.(Prior to discharge and again at 2 weeks follow up)
研究者
Lindsay Turner
Director of Urogynecology, Principal Investigator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)