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

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ClinicalTrials.gov Identifier: NCT02283684
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Procedure: Greenlight laser PVP Procedure: Bipolar TUVP Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Greenlight laser PVP
Greenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system
Procedure: Greenlight laser PVP
Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
Other Name: Greenlight (532-nm) laser PVP using (XPS) 180W system

Active Comparator: Bipolar TUVP
Bipolar transurethral vaporization of the prostate using bipolar system
Procedure: Bipolar TUVP
Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma




Primary Outcome Measures :
  1. IPSS change [ Time Frame: two years ]
    change in the symptoms score over two years post procedure


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients' age ≥50 years
  2. LUTS secondary to BOO due to BPH who failed medical treatment
  3. International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
  4. 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.
  5. ASA (American society of anaesthesiologists) score ≤3.
  6. TRUS prostate size (from 30 to 80ml)

Exclusion Criteria:

  1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  2. Active urinary tract infection,
  3. Presence of active bladder cancer (within the last 2 years)
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283684


Locations
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Egypt
Urology and Nephrology Center
Mansoura, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed M Elshal, MD Mansoura University

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Responsible Party: Ahmed Elshal, Lecturer of Urology, Mansoura University
ClinicalTrials.gov Identifier: NCT02283684     History of Changes
Other Study ID Numbers: Mans-2014-03
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Keywords provided by Ahmed Elshal, Mansoura University:
LASER
PROSTATE
BIPOLAR
HYPERPLASIA
VAPORIZATION
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male