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Completed

NCT Number: NCT02283684

GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT

With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.

In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

About this study

Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.

Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients' age ≥50 years
  • LUTS secondary to BOO due to BPH who failed medical treatment
  • International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
  • Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
  • ASA (American society of anaesthesiologists) score ≤3.
  • TRUS prostate size (from 30 to 80ml)

Exclusion criteria

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection,
  • Presence of active bladder cancer (within the last 2 years)
  • Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Treatment and study plan

Greenlight laser PVP

Procedure

Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber

Other names: Greenlight (532-nm) laser PVP using (XPS) 180W system

Bipolar TUVP

Procedure

Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma

Primary outcomes

  1. IPSS change

    Time frame: two years

    change in the symptoms score over two years post procedure

Secondary outcomes

  1. Reoperation rate

    Time frame: 4 years

    need for reintervention post procedure

  2. Q.max

    Time frame: 2 years

    maximal urine flow rate

  3. biopsy

    Time frame: one month

    clinicopathological outcome

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Nov 5, 2014
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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