A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) With Prostate Volumes Between 30-80 Grams
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- International Prostate Symptom Score (IPSS)
研究概览
简要总结
To compare the surgical outcomes at 12 months post-surgery between Bipolar TURP and BipoLEP in men with BPH and prostate volumes between 30-80 grams.
详细描述
Create a research protocol in a prospective study to compare bipolar transurethral resection of prostate vs bipolar enucleation of prostate between 30 and 80 gm in management of BPH
Okay, here's a detailed research protocol for a prospective study comparing Bipolar Transurethral Resection of the Prostate (TURP) and Bipolar Enucleation of the Prostate (BipoLEP) for BPH, specifically focusing on prostates between 30-80 grams:
Study Title: A Prospective Randomized Controlled Trial Comparing Bipolar TURP and Bipolar Enucleation of the Prostate for Benign Prostatic Hyperplasia (BPH) with Prostate Volumes between 30-80 grams
- Introduction
Background: Briefly introduce Benign Prostatic Hyperplasia (BPH), its prevalence, and the associated lower urinary tract symptoms (LUTS). Highlight the common surgical interventions: TURP and, more recently, enucleation techniques.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 45-80 years diagnosed with symptomatic BPH.
- •Prostate volume between 30-80 grams as determined by transrectal ultrasound (TRUS) performed within 4 weeks before randomization.
- •Moderate to severe LUTS with an IPSS of ≥
- •Failure of medical management.
- •Patients able to provide written informed consent.
排除标准
- •History of prostate cancer.
- •History of previous prostate surgery (including any procedure for BPH or prostate cancer).
- •History of urethral stricture or bladder neck contracture.
- •Neurogenic bladder dysfunction.
- •Significant coagulopathy.
- •Uncontrolled urinary tract infection.
- •Patient on anticoagulant medication.
结局指标
主要结局
International Prostate Symptom Score (IPSS)
时间窗: 12 months
Qmax
时间窗: 12 months
次要结局
- Complications(12 months)
- PVR(12 months)
研究者
Samer Morsy
Associate Professor
Kasr El Aini Hospital