On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo.
研究概览
简要总结
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP. However, no study has examined the effect of preoperative Finasteride on clinical outcomes.
The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are standard units of red blood cells transfused, variables related to perioperative bleeding (incidence of readmission, incidence of return to hospital, length of hospital stay), blood loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected prostate tissue, operating time, change in AUA-SS, and change in HRQOL.
详细描述
The proposed trial is warranted for two main reasons. First, no study has examined the effect of preoperative Finasteride on important clinical outcomes such as the incidence of red blood cell transfusion, standard units of red blood cells transfused, readmission, return to hospital, and length of hospital stay. Second, a definitive randomized, double-blind, placebo-controlled trial documenting the efficacy of preoperative Finasteride on blood loss variables (e.g., intra-operative blood loss, change in serum hemoglobin) has yet to be conducted.
Participants will be recruited from the practices of Credentialed Urologists at the Alberta Urology Institute (AUI) and UAH in Edmonton, Alberta, Canada. The eligibility criteria include medical, demographic, and logistic criterion, and focus on internal validity as well as external validity. Eligibility criteria for the study are: (1) TRUS-confirmed prostate gland > 30 g, (2) 18 years of age or older, (3) fit and scheduled to receive TURP, (4) approval of the treating urologist, (5) able to understand and provide written informed consent in English, (6) no active psychiatric condition, (7) no previous Finasteride use, (8) normal DRE, (9) PSA greater than or equal to 4.0 ng/ml, (10) no current anticoagulation use (Heparin, Warfarin), (11) no ESRD, (12) no previous prostate or urethral surgery, and (13) not deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •TRUS-confirmed prostate gland > 30 g,
- •18 years of age or older,
- •fit and scheduled to receive TURP,
- •approval of the treating urologist,
- •able to understand and provide written informed consent in English
排除标准
- •active psychiatric condition,
- •previous Finasteride use,
- •abnormal DRE,
- •PSA greater than 4.0 ng/ml,
- •current anticoagulation use (Heparin, Warfarin),
- •previous prostate or urethral surgery,
- •deemed to be a candidate for immediate surgery (within 1 week of initial evaluation).
研究组 & 干预措施
1
Finasteride 5 mg PO once daily for 8 weeks prior to TURP
干预措施: Finasteride (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo.
时间窗: During/post surgery
次要结局
- To compare standard units of red blood cells transfused, variables related to perioperative bleeding, blood loss, serum hemoglobin, serum hematocrit, blood loss per gram of resected prostate tissue, operating time, AUA-SS, HRQOL after TURP(during/post surgery)