HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH

Mansoura University182 enrolled

Overview

Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate. In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.

With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight 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 Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of LUTS secondary to BPH in a prospective randomized trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. The prostate size limitations will be assessed in relation to the outcome measures. Moderate to large size prostate (80-120 ml TRUS estimated volume) will be randomized to PVEP vs. Bipolar TURP vs. HoLEP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

182

Conditions

Benign Prostate Hyperplasia Lower Urinary Tract Symptoms

Interventions

532nm-laser photoselective vapo-enucleation of the prostate)PROCEDURE

using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)

Holmium laser enucleation of prostatePROCEDURE

Holmium-Yag laser enucleation of the prsotate

Bipolar TURPPROCEDURE

Bipolar transurethral resection of the prostate in saline

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients' age ≥50 years 2. LUTS secondary to BOO due to BPH who failed medical treatment 3. International prostate symptom scores 8 (IPSS) \>15 and bother score 8 (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 (\>/=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.

Locations (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Outcomes

Primary Outcomes

Re treatment

need for retreatment for recurrent infravesical obstruction following primary surgery

Time frame: 3 YEARs

Secondary Outcomes

change in symptoms score

degree of improvement in the lower urinary tract symptoms

Time frame: 3 year

Urine Flow rate (ml/sec)

degree of improvement in the rate of urine flow

Time frame: 3 year

Data from ClinicalTrials.gov

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