A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- maximum urinary flow rate(Qmax)
研究概览
简要总结
This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.
详细描述
A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High-Frequency Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
One hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. The primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of International Prostate Symptom Score at 3 months after surgical treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age over 40 years old
- •Qmax <15ml/s
- •Prostatic volume range of 30 to 100ml, measured by MRI
- •Fully understand the clinical trial protocol and sign the informed consent
排除标准
- •Have a history of prostate cancer or patients suspicious of prostate cancer Neurogenic bladder Metal implants in their body Previous history of prostatic or urethral surgery With Catheterisation more than 2 weeks Any other conditions that investigator judges that participations who are not suitable for this trial
研究组 & 干预措施
High Freqnence Irreversible Electroporation
Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia
干预措施: High freqnence Irreversible electroporation (Procedure)
Trans Urethral Resection Prostate
Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia
干预措施: Trans Urethral Resection Prostate (Procedure)
结局指标
主要结局
maximum urinary flow rate(Qmax)
时间窗: 1 and 3 months after surgical treatment
the change from baseline in maximum urinary flow rate(Qmax)
urination function(evaluated by International prostate symptom score, IPSS)
时间窗: 1 and 3 months after surgical treatment
the change from baseline in IPSS (International prostate symptom score)
次要结局
- sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)(1 and 3 months after surgical treatment)
- sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)(1 and 3 months after surgical treatment)
- post-void residual urine volume (PVRU)(1 and 3 months after surgical treatment)
- urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)(1 and 3 months after surgical treatment)
- urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item(1 and 3 months after surgical treatment)
- quality of life (QOL) evaluated by IPSS QoL subscore(1 and 3 months after surgical treatment)
- quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))(1 and 3 months after surgical treatment)
- perioperative parameters(operative time)(1 month)
- perioperative parameters(the postoperative hospital stay)(1 month)
- perioperative parameters(haemoglobin declination)(6 hours, 24 hours after surgical treatment)
- perioperative parameters(serum sodium declination)(6 hours, 24 hours after surgical treatment)
- perioperative parameters(catheterisation duration)(1 month)
- early postoperative urinary symptoms(1 and 3 months after surgical treatment)
- pain measured by a surgical pain scale(24 hours, 1 week, 1 month and 3 months)
- adverse event(1 and 3 months after surgical treatment)
- voided volume(1 and 3 months after surgical treatment)