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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- IPSS change [ Time Frame: two years ]change in the symptoms score over two years post procedure
- Reoperation rate [ Time Frame: 4 years ]need for reintervention post procedure
- Q.max [ Time Frame: 2 years ]maximal urine flow rate
- biopsy [ Time Frame: one month ]clinicopathological outcome
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
|Urology and Nephrology Center|
|Mansoura, Aldakahlia, Egypt, 35516|
|Principal Investigator:||Ahmed M Elshal, MD||Mansoura University|