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

NCT ID: NCT02283684

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-02-28

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Greenlight laser PVP

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

Group Type: ACTIVE_COMPARATOR

Greenlight laser PVP

Intervention Type: PROCEDURE

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

Bipolar TUVP

Bipolar transurethral vaporization of the prostate using bipolar system

Group Type: ACTIVE_COMPARATOR

Bipolar TUVP

Intervention Type: PROCEDURE

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

Interventions

Greenlight laser PVP

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

Intervention Type: PROCEDURE

Bipolar TUVP

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

Intervention Type: PROCEDURE

Other Intervention Names

Greenlight (532-nm) laser PVP using (XPS) 180W system

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Elshal

Lecturer of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Elshal, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

Other Identifiers

Mans-2014-03

Identifier Type: -

Identifier Source: org_study_id