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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283684
• Other study ID #: Mans-2014-03
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: February 2018

Study information

• Verified date: June 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2018
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Greenlight laser PVP
Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
• Bipolar TUVP
Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS change	change in the symptoms score over two years post procedure	two years
Secondary	Reoperation rate	need for reintervention post procedure	4 years
Secondary	Q.max	maximal urine flow rate	2 years
Secondary	biopsy	clinicopathological outcome	one month