A Multicentre Randomised Controlled Trial Evaluating the Benefit of Median Lobe Preservation on the Incidence of Retrograde Ejaculation During Prostate Enucleation by HoLEP.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Retrograde ejaculation
研究概览
简要总结
A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.
详细描述
The main objective of the study is to compare the incidence of retrograde ejaculation at 6 months in patients undergoing Holep surgery for prostatic adenoma according to two randomized surgical techniques: conventional surgical procedure of removal of the 3 prostatic lobes versus preservation of the median lobe.
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)
盲法说明
The patient does not know which type of surgery is used
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 years and older who have signed their consent to participate in the study
- •Patient with preserved cognitive functions
- •Patient with BPH characterised by an IPSS score ≥ 12, a Qmax ≤ 15 ml/s and an ultrasound-assessed prostate volume between 40 and 150 cc
- •Patient for whom an indication for prostatic resection by HoLEP has been made,
- •A patient who is sexually active and willing to maintain sexual activity after surgery
- •Patient affiliated to a social security system or beneficiary of such a system
排除标准
- •History of prostate surgery or prostate radiotherapy
- •Urethral stenosis
- •Cancer or a history of cancer
- •Patient with a life expectancy of less than 2 years
- •Patient refusing partial surgery
- •History of vasectomy, erectile dysfunction or ejaculation
- •Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- •Patient under court protection, guardianship or curatorship
- •Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
结局指标
主要结局
Retrograde ejaculation
时间窗: Month 6
Existence of retrograde ejaculation at Month 6, as evidenced by the presence of spermatozoa in the urine following sexual intercourse (as evidenced by an ECBU performed within 24 hours of intercourse)
次要结局
- Assessment of resected volume / total volume(Month 12)
- International Prostate Symtom Score (IPSS) assessment(Month 12)
- Men Sexual Health Questionnaire (MSHQ) score assessment(Month 12)
- Urine flow (Qmax) measurement(Month 12)
- Adverse events related to the procedure(Month 12)
- International Index of Erectil Function (IIEF-5) score assessment(Month 12)