Back to results

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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Greenlight laser PVP

Bipolar TUVP

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Greenlight laser PVP

Bipolar TUVP

Arm Description

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

Bipolar transurethral vaporization of the prostate using bipolar system

Outcomes

Primary Outcome Measures

IPSS change

change in the symptoms score over two years post procedure

Secondary Outcome Measures

Reoperation rate

need for reintervention post procedure

Q.max

maximal urine flow rate

biopsy

clinicopathological outcome

Full Information

NCT ID

NCT02283684

First Posted

November 2, 2014

Last Updated

June 9, 2019

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT02283684

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Greenlight laser PVP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Bipolar TUVP

Arm Type

Active Comparator

Arm Description

Bipolar transurethral vaporization of the prostate using bipolar system

Intervention Type

Procedure

Intervention Name(s)

Greenlight laser PVP

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Bipolar TUVP

Intervention Description

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

Primary Outcome Measure Information:

Title

IPSS change

Description

change in the symptoms score over two years post procedure

Time Frame

two years

Secondary Outcome Measure Information:

Title

Reoperation rate

Description

need for reintervention post procedure

Time Frame

4 years

Title

Q.max

Description

maximal urine flow rate

Time Frame

2 years

Title

biopsy

Description

clinicopathological outcome

Time Frame

one month

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed M Elshal, MD

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Urology and Nephrology Center

City

Mansoura

State/Province

Aldakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs