Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Enrollment Effectiveness
研究概览
简要总结
The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.
详细描述
The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery. Primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Active treatment of Benign Prostatic Hyperplasia (BPH)
- •Hypersensitivity or allergy to tamsulosin HCL
- •Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
- •Active urinary tract infection
- •History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy.
- •History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
- •Underlying neurological disorders resulting in impaired bladder function
- •Any known contraindication to the use of tamsulosin HCL
- •Nursing/ Breastfeeding women
- •Use of intraoperative bladder catheter
- •patients for whom cataract and/or glaucoma surgery is scheduled.
- •patients on strong inhibitors of CYP3A4 (e.g., ketoconazole), on moderate inhibitors of CYP3A4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of CYP2D6 or in patients known to be CYP2D6 poor metabolizers.
- •patients with a serious or life-threatening sulfa allergy
- •patients with severe hepatic insufficiency
- •patients with severe renal impairment (creatinine clearance of <10 mL/min)
- •patients with a serious or life-threatening sulfa allergy
研究组 & 干预措施
Treatment
Tamsulosin
干预措施: Tamsulosin Hydrochloride (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Enrollment Effectiveness
时间窗: 4 months
Percentage of Screen eligible patients consenting to the study
Monthly recruitment
时间窗: 4 months
Rate of monthly recruitment
Protocol adherence
时间窗: 4 Months
Percentage of enrolled patient adherent to protocol during intervention phase
次要结局
- Rate of Straight Catheterizations(30 days post-op)
- Rate of Indwelling Catheterizations(30 days post-op)
- Catheter related complications(30 days post-op)
- Time to first catheterization(up to 30 days post-op)
- Treatment Related Adverse Events(30 days post-op)
- Length of stay(30 days post-op)
研究者
Rahul Nayak
MD MSc FRCSC
Lawson Health Research Institute