A Comparative Study Of Clinical Outcomes Of Bipolar Enucleation Of The Prostate Versus Bipolar TURP In Management Of Benign Prostatic Hyperplasia : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- volume of residual prostatic adenoma
研究概览
简要总结
Bipolar enucleation of the prostate (BEEP) was introduced to treat patients with large prostate. The study compared the functional outcomes and perioperative complications of bipolar TURP and bipolar enucleation of large prostates above 80 gm.
详细描述
Recent literature suggests that enucleation techniques may provide superior functional results, reduced bleeding, and lower retreatment rates. Nevertheless, there remains limited high-quality randomized controlled data directly comparing bipolar TURP and bipolar enucleation of prostate as a head to head comparison regarding functional outcomes and peri-operative complications.
In this study, a randomized controlled trial was performed to compare bipolar enucleation of the prostate versus bipolar transurethral resection of the prostate in BPH regarding symptoms relief, residual adenoma, urine flow rate and post-operative morbidity.
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, Outcomes Assessor)
盲法说明
A statistician randomized the eligible patients using block randomization with a block size of 8. Allocation concealment was achieved using sequentially numbered opaque sealed envelopes. The participants were blinded to the assigned type of intervention at the time of surgery. Outcome assessors also were blinded, whereas surgeons were not blinded.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male patients above the age of 40 years who presented to the urology clinic in Ain Shams university hospitals with BPH with prostate size 80 - 120 g and have any of the following criteria:
- •Voiding symptoms that are poorly responsive to medical treatment (IPSS more than 18 and Qmax less than 15 ml/sec)
- •Persistent or recurrent attacks of urine retention due to BPH.
- •Large bladder stones from BPH.
- •Recurrent UTI due to BPH.
- •Severe gross hematuria from BPH.
排除标准
- •Patients with untreated or active UTI.
- •Previous pelvic radiation or pelvicl trauma.
- •Patients with anesthesia contraindications such as uncontrolled diabetes mellitus, severe coagulation disorders and severe cardiac diseases.
- •Known or suspected neurogenic bladder.
- •Urethral stricture or urethral cancer.
研究组 & 干预措施
bipolar TURP
transurethral resection of the prostate by bipolar current
干预措施: bTURP (Procedure)
BEEP
endoscopic enucleation of the prostate by bipolar current
干预措施: BEEP (Procedure)
结局指标
主要结局
volume of residual prostatic adenoma
时间窗: one month postoperative
measurement of volume of residual prostatic adenoma post bipolar TURP and BEEP was done by pelvi-abdominal ultrasound
change in international prostate symptoms score
时间窗: pre-operative, one, three, six and twelve months postoperative
The international prostate symptoms score is a patient-completed questionnaire for standardized assessment of lower urinary tract symptoms (LUTS). It includes seven questions that evaluate the following urinary symptoms: * Weak urinary stream (0 : 5) * Incomplete bladder emptying (0 : 5) * Straining during urination (0 : 5) * Intermittent urine flow (0 : 5) * Increased urinary frequency (0 : 5) * Urgency (0 : 5) * Nocturia (0 : 5) Grade 1 (score = 0 - 7) : Mild LUTS Grade 2 (score = 8 - 19) : Moderate LUTS Grade 3 (score = 20 - 35) : Severe LUTS
improvement in maximum urine flow rate(Q max)
时间窗: pre-operative, 1, 3, 6 and 12 months postoperative
Maximum urine flow rate was evaluated by Uroflowmetry
change in maximum urine flow rate(Q max)
时间窗: pre-operative, 1, 3, 6 and 12 months postoperative
Maximum urine flow rate was evaluated by Uroflowmetry
次要结局
- reduction in post voiding residual urine(pre-operative, 1, 3, 6 and 12 months postoperative)
- operation time(during operation)
- change in post voiding residual urine(pre-operative, 1, 3, 6 and 12 months postoperative)
研究者
Amgad Abdel Aziz
Principal Investigator
Ain Shams University