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

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: Bipolar TUVP; Procedure: Greenlight laser PVP

• Registration Number: NCT02283684
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-02
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Primary Completion: 2015-11
• Study Completion: 2018-02
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-09
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar TUVP	Bipolar TUVP	Bipolar transurethral vaporization of the prostate using bipolar system
Greenlight laser PVP	Greenlight laser PVP	Greenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system

Primary Outcome Measures

Name	Time	Method
IPSS change	two years	change in the symptoms score over two years post procedure

Secondary Outcome Measures

Name	Time	Method
Reoperation rate	4 years	need for reintervention post procedure
Q.max	2 years	maximal urine flow rate
biopsy	one month	clinicopathological outcome

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Aldakahlia, Egypt