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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial Comparing Holmium Laser Enucleation of the Prostate vs. Greenlight 532nm-laser Vapo-Enucleation of the Prostate vs. Bipolar Transurethral Resection of the Prostate in Management of Moderate/Large Benign Prostate Hyperplasia

Conditions
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Benign Prostate Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Procedure: 532nm-laser photoselective vapo-enucleation of the prostate)
* Procedure: Holmium laser enucleation of prostate
* Procedure: Bipolar TURP


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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Greenlight (532nm-laser) PVEP<br>532nm-laser photoselective vapo-enucleation of the prostate) | Procedure: 532nm-laser photoselective vapo-enucleation of the prostate)<br>* using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)<br>|
| Active Comparator: Holmium laser enucleation of prostate<br>Holmium-Yag laser enucleation of the prostate | Procedure: Holmium laser enucleation of prostate<br>* Holmium-Yag laser enucleation of the prsotate<br>|
| Active Comparator: Bipolar TURP<br>Bipolar transurethral resection of the prostate in saline | Procedure: Bipolar TURP<br>* Bipolar transurethral resection of the prostate in saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re treatment | need for retreatment for recurrent infravesical obstruction following primary surgery | 3 YEARs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in symptoms score | degree of improvement in the lower urinary tract symptoms | 3 year | 
| Urine Flow rate (ml/sec) | degree of improvement in the rate of urine flow | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION