Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 336
- 试验地点
- 18
- 主要终点
- Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
研究概览
简要总结
It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.
详细描述
The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment.
Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
- The clinical research assistant will fill-out the electronic case report form (eCRF) "randomisation" page and perform the randomisation. The site will immediately provide the study identification number for the patient and the allocation group.
- The clinical research assistant will print the result of the randomisation. The printed document will be placed in a sealed envelope that will be stored in the patient's file.
- The surgeon will open the envelope in the operating theatre once the patient has been placed under general anaesthesia.
To prevent breaking the blinding post-operatively, the complete or partial aspect of endoscopic resection will not be mentioned in the surgical report (the patient will be specifically informed of that particular point before signing the informed consent). The complete or partial aspect of surgery will be revealed to patients at the end of follow-up, and in case of any surgical problem (e.g. need for re-intervention) or consent withdrawal.
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
- •Man over 40 years old
- •Indication of surgical management for BPH
- •Prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an MRI if available)
- •IPSS score ≥12
- •Qmax ≤15 ml/s
- •Affiliated to French national social security system
- •wish and be able to comply with planned visits
- •Able to express his consent
- •Signed informed consent form
排除标准
- •Unwillingness to accept the treatment
- •No pre-operative ejaculation or sexuality
- •Neurological pathology responsible for micturition disorders
- •History of prostatic surgery
- •Stenosis of the urethra symptomatic
- •History of prostate cancer
- •History of radiotherapy or pelvic surgery
- •Patient refusing the principle of partial surgery
- •Life expectancy <3 years
- •Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
- •Participation in another clinical study involving an investigational product within 1 month before study entry.
研究组 & 干预措施
Conventional endoscopic prostatic surgery
Endoscopic resection of prostate.
干预措施: Conventional endoscopic prostatic surgery (Procedure)
Partial surgery preserving the prostatic apex
Patients randomised to the partial endoscopic resection group will undergo surgical treatment that preserves the apex area of the prostate (tissue located 1 cm around the veru montanum).
干预措施: Partial surgery preserving the prostatic apex (Procedure)
结局指标
主要结局
Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months
时间窗: 6 months after surgery
the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points).
次要结局
- Evaluation of ejaculation and global sexual life(1 month, 3 months, 6 months,12 months, and 36 months after surgery)
- Evaluation of lower urinary tract symptoms(1 month, 3 months, 6 months,12 months, and 36 months after surgery)
- Evaluation of complication rates(1 month, 3 months, 6 months,12 months, and 36 months after surgery)