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临床试验/NCT04529369
NCT04529369尚未招募不适用

Efficacy and Long-term Durability of Middle Lobe Only (MLO) Versus Complete Trans-Urethral Vaporization of the Prostate (PVP), Prospective Cohort Study.

Jewish General Hospital0 个研究点目标入组 280 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
280
主要终点
MSHQ-EJD

研究概览

简要总结

The investigator aims to prospectively investigate the efficacy and durability of the middle lobe only versus traditional complete photoselective greenlight vaporization of the prostate in patients with prominent middle lobe. The investigator will select patients based on pre-op cystoscopy if patients have a prominent middle lobe to participate in this study. Researches will start to vaporize only the middle lobe then, at the end of this step, The investigator will look at the verumontanum into the prostatic fossa and determine if the patient is having adequate opened prostatic fossa or not. Patients with unsatisfactory opened fossa will have a complete PVP of lateral lobes, while patients with a satisfactory channel will not receive a complete PVP. Primary objectives of the study are to look into pre and post-operative uroflowmetry and post-void residual, International prostate symptoms scores, need of catheterization, and need for secondary interventions over five then ten years. Secondary objectives are to look into erectile and ejaculatory status using the Male Sexual Health Questionnaire (MSHQ) and MSHQ-EjD Short Form for Assessing EjD. Researchers will follow the patients at three months, six months, one year then yearly for five years then an extension to up to 10 years.

详细描述

Introduction:

Transurethral resection of the prostate (TURP) is considered the treatment of choice for patients suffering from benign prostatic hyperplasia (BPH) refractory to medical treatments or in patients with refractory urinary retention (1). It involves complete resection of the transitional zone of the prostate from the verumontanum to the bladder neck (2). Classical TURP has a high risk of ejaculatory dysfunction (65-70%) (2), and a 7% to 13% risk of bleeding that requires transfusion (3). To reduce these complications, newer technologies have been introduced to lower these associated risks, such as greenlight laser, Rezum, and Urolift (1).

The dynamic of bladder outlet obstruction related to BPH adenoma site and distribution has not been completely elucidated. In a study that looked into this relationship, it suggested that the presence of intravesical prostatic protrusion (IPP) has been associated with the presence of prostatic adenoma with high sensitivity (95.4%), a high specificity (100%), and a high positive predictive value (100%), with the negative predictive value of (50%). Furthermore, the mean maximum flow rate (Qmax) in patients with only lateral lobe prostatic adenoma evaluated by cystoscopy was 16ml/s, while patients with middle lobe only adenoma have a flow max of 11.6 ml/s. When patients have both middle and lateral lobes, the mean Qmax was 8.9 ml/sec (4). These findings highlight the major role of middle lobe adenoma and intravesical prostatic protrusion (which is usually an extension of the middle lobe), into the urodynamics of bladder outlet obstruction. Also, the intravesical prostatic extension has been suggested to cause a "ball-valve" effect that contributes significantly to the urodynamic bladder outlet obstruction (5). In a retrospective study, middle lobe only TURP for patients with prominent middle lobe adenoma and IPP of more than 10 mm, in patients with bothersome BPH symptoms or urinary retention, was associated with improvement in Qmax, Post-void residual and reduction of the international prostate symptoms score (IPSS), over a follow-up period up to 12 years. The urodynamic outcomes were comparable to traditional TURP results but with no change in ejaculatory bother scores pre and postoperatively. It also enabled including patients with larger prostate sizes (up to 178 g) that would require open prostatectomy or complete laser enucleation of the prostate (5).

Rationale:

Middle-lobe only TURP procedure has demonstrated durable, successful urodynamic outcomes in patients with significant bladder outlet obstruction caused by middle lobe with IPP of more than 10 mm, with no change in ejaculatory status after such procedure in retrospective fashion (5). No prospective studies have been done to document this effect. Also, the use of this procedure in patients with predominant meddle-lobe prostatic adenoma with minimal or no IPP has not been evaluated. Furthermore, the use of greenlight vaporization, which is proven to cause a significant reduction in blood loss, blood transfusion, and reduced hospital stay when compared to traditional TURP (6).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Adult males (18-year-old and more)
  • •Suffering bothersome LUTS or urinary retention secondary to BPH
  • •Cystoscopic examination documenting the predominant middle lobe prostatic adenoma that is considered to be the primary cause of BOO.

排除标准

  • •Patients neurogenic lower urinary tract dysfunction (Neurogenic Bladder)
  • •Not competent to give consent and/or inability to provide answers to the questionnaire
  • •Patient who refuse to participate in the study
  • •Patients without a median lobe
  • •Patients who have a large prostate (more than 120 g on trans-abdominal ultrasound prostate sizing).
  • •Patients who have renal impairment secondary to BPH
  • •Patients with proven or suspicion of prostate cancer based on clinical examination and/or PSA level
  • •Patients with refractory hematuria secondary to BPH
  • •Patients with urethral strictures
  • •Patients with bladder cancer
  • •Patients with history of pelvic radiotherapy

研究组 & 干预措施

Prominent middle lobe BPH satisfactory channel after MLO PVP

Experimental

干预措施: Middle lobe only Photoselective vaporization of the prostate (PVP) (Procedure)

Prominent middle lobe BPH unsatisfactory channel after MLO PVP

Active Comparator

干预措施: Complete PVP (Procedure)

结局指标

主要结局

MSHQ-EJD

时间窗: 3 months to 5 years

The difference in Male sexual health questionnaire ejaculatory dysfunction (MSHQ-EjD) pre and post interventions and compare it between groups

Inability to void

时间窗: 3 months

incidence of inability to void that needs surgical intervention after Middle lobe only PVP compared to complete PVP

IPSS

时间窗: 3 months to 5 years

The difference in international prostate symptoms score (IPSS) pre and post interventions and compare it between groups

Qmax

时间窗: 3 months to 5 years

The difference in Maximal flow rate (Qmax) pre and post interventions and compare it between groups

PVR

时间窗: 3 months to 5

The difference in Post void residual pre and post interventions and compare it between groups

次要结局

  • bleeding(3 months)
  • additional medications(3 months to 5 years)
  • rate of patients with prominent middle lobe who needs MLO PVP(3 months to 5 years)
  • dysuria(3 months to 5 years)
  • Efficaciy of MLO based on prostate size, PSA, IPP and/or lateral lobes adenine(3 months to 5 years)
  • additional treatment(3 months to 5 years)
  • Erectile dysfunction MSHQ(3 months to 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacques Corcos

Professor of Surgery (Urology)

Jewish General Hospital

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