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

NCT02283684 | Completed Phase 4

• 1 other identifier: Mans-2014-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

LASER; PROSTATE; BIPOLAR; HYPERPLASIA; VAPORIZATION

Outcome Measures

Primary Outcomes (1)

• IPSS change

  change in the symptoms score over two years post procedure

  two years

Secondary Outcomes (3)

• Reoperation rate

  4 years

• Q.max

  2 years

• biopsy

  one month

Study Arms (2)

Greenlight laser PVP

ACTIVE COMPARATOR

Greenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system

Procedure: Greenlight laser PVP

Bipolar TUVP

ACTIVE COMPARATOR

Bipolar transurethral vaporization of the prostate using bipolar system

Procedure: Bipolar TUVP

Interventions

Greenlight laser PVP PROCEDURE

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

Also known as: Greenlight (532-nm) laser PVP using (XPS) 180W system

Greenlight laser PVP

Bipolar TUVP PROCEDURE

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

Bipolar TUVP

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Hyperplasia

Interventions

Photoelectron Spectroscopy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ahmed M Elshal, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 5, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

EG (1)