Laser Vaporization of the Prostate: Comparative Study Between Ejaculatory Preserving and Non-ejaculatory Preserving Technique
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- post voiding residual urine
研究概览
简要总结
The present work aimed to compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique .
详细描述
Benign prostate hyperplasia (BPH) is a histological diagnosis which is identified by non-malignant hyperplasia of prostatic tissue due to smooth muscle and epithelial cell proliferation in the prostate transition zone.
The prevalence of histologically diagnosed (BPH) increases from 8% in men aged 31 to 40 years old to 40-50% in men aged 51 to 60 years old. This increases to over 80% in men older than 80 years old.
Bladder outlet obstructions (BOO) are one of the major disorders in the aging male, The most common aetiology of BOO in elderly men above the age of 60 years is (BPH), but younger men (< 50 years old) can also experience infra vesical obstruction from a small but obstructive prostate.
Ejaculation is one of the fundamental domains of male sexual function An almost inevitable adverse event of the conventional TURP is the loss of antegrade ejaculation, seen in 65%-80% of patients.
The use of alpha receptor antagonists is also known to cause a loss in antegrade ejaculation. Aside from peri- and postoperative morbidities, such as bleeding and TURP syndrome, the loss of ejaculation represents a major reason for the avoidance of surgical treatment. This is a particular issue among young people who hesitate to agree to the TURP procedure due to the fear of loss of ejaculation. Losing the ability to ejaculate often leads to a subsequent decrease in sexual pleasure, which has psychosocial implications but can also impact on aspects related to their cultural background, desire for children, and sexual life.
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age >45 years old, clinical diagnosis of BOO by medical history and physical examination (including digital rectal examination)
- •International prostate symptoms score (IPSS) >14 points
- •Normal PSA (PSA<4 ng / ml or free/ total PSA >0.25)
- •Prostate size < 80 gm
- •Men with recurrent urinary retention (drug-refractory), urinary infection, or haematuria who had failed standard medical therapy (alpha-blockers, 5-alpha reductive inhibitors)
- •Patients were also required to have an active and healthy sexual life, the ability to ejaculate and a desire to preserve ejaculation
排除标准
- •Major psychiatric and somatic diseases and the use of drugs that affect sexual function
- •Patients with ejaculatory dysfunction or no ejaculation
- •Patients with documented or suspected prostate cancer
- •Patients with neurogenic bladder, voiding dysfunction, urethral strictures, and malignancies of the upper or lower urinary tract,
- •Prostates sized more than 80 CC, severe comorbidities or high surgical risk patients.
研究组 & 干预措施
conventional technique laser vaporization prostatectomy
non ejaculatory preserving laser vaporization of the prostate
干预措施: conventional technique of laser vaporization of the prostate (Procedure)
new technique of ejaculatory preserving laser vaporization prostatectomy
laser will be employed to preform vaporization. The ejaculatory preserving procedure will be done in the following steps:
- Setting a mark cut 1 cm proximal of the verumontanum as orientation.
- Complete resection of the middle lobe to the abovementioned mark.
- Vaporization of lateral lobes to the capsule and the ventral side to the level of the verumontanum with avoidance of paracollicular digging.
- Circular resection of the internal bladder neck.
- Apical resection utilizing the colliculus seminalis as a distal resection border and maintaining a 1cm safety area for preservation of ejaculation.
- Total removal of prostate cuts and final check to confirm that there are no obstructive components.
干预措施: new technique of ejaculatory preserving laser prostatectomy (Procedure)
结局指标
主要结局
post voiding residual urine
时间窗: 1 year
Post-void residual urine (PVR) is the amount of urine that remains in the bladder after urinating. It can be estimated by ultrasound or measured by catheterization1. A small amount of PVR is normal, but a high amount can indicate a urinary obstruction or other problems
international prostate symptoms score (IPSS)
时间窗: one year
Score: 1-7: Mild 8-19: Moderate 20-35: Severe 1. Incomplete Emptying How often have you had the sensation of not emptying your bladder? 0 1 2 3 4 5 2. Frequency How often have you had to urinate less than every two hours? 0 1 2 3 4 5 3. Intermittency How often have you found you stopped and started again several times when you urinated? 0 1 2 3 4 5 4. Urgency How often have you found it difficult to postpone urination? 0 1 2 3 4 5 5. Weak Stream How often have you had a weak urinary stream? 0 1 2 3 4 5 6. Straining How often have you had to strain to start urination? 0 1 2 3 4 5 None 1 Time 2 Times 3 Times 4 Times 5 Times 7. Nocturia How many times did you typically get up at night to urinate? 0 1 2 3 4 5
compare between The Outcomes of conventional technique of laser prostatectomy versus the new ejaculatory sparing technique regarding semen volume
时间窗: one year
decreased,vanished or the same
maximum flow rate of the urine after the procedure (Qmax )
时间窗: one year
maximum flow rate increased or decreased or the same Qmax Interpretation \* is higher than 15ml/sec Normal 10-15ml/sec Equivocal is lower than 10ml/sec Obstruction or weak detrusor
次要结局
未报告次要终点