Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatments greenlight laser pvp, bipolar pkvp
Phase phase 4
Sponsor Mansoura University
Start date September 2014
End date November 2015
Trial size 120 participants
Trial identifier NCT02283684, Mans-2014-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Greenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system
greenlight laser pvp Greenlight (532-nm) laser PVP using (XPS) 180W system
Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
(Active Comparator)
Plasma Kinetic vaporization of the prostate using bipolar system
bipolar pkvp
Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma

Primary Outcomes

Measure
IPSS change
time frame: one year

Secondary Outcomes

Measure
Reoperation rate
time frame: 3 years
Q.max
time frame: one year
biopsy
time frame: one month

Eligibility Criteria

Male participants at least 50 years old.

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.

Additional Information

Official title Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Plasma Kinetic Vaporization (PKVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Controlled Study
Principal investigator Ahmed M Elshal, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Mansoura University.