Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

Study Overview
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Brief Summary
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Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.

Official Title
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Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial

Conditions
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Prostate Hypertrophy, Holmium Laser, Thulium Laser, Bipolar Diathermy, Prostate Enucleation

Intervention / Treatment
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* Procedure: Holmium Laser
* Procedure: Thulium Laser
* Procedure: Bipolar diathermy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' age >50 years Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8) Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment. Transrectal ultrasound TRUS estimated total prostate size 80-250cc Exclusion Criteria: Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease Active urinary tract infection (positive urine culture) till treatment Presence of 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Holmium Laser<br>holmium laser enucleation of the prosteate | Procedure: Holmium Laser<br>* Holmium laser enucleation of large sized prostate<br>* Other names: HoLEP;|
| Active Comparator: Thulium Laser<br>Thulium laser enucleation of the prosteate | Procedure: Thulium Laser<br>* Thulium laser enucleation of large sized prostate<br>* Other names: ThuLEP;|
| Active Comparator: Bipolar Enucleation<br>Bipolar enucleation of the prosteate | Procedure: Bipolar diathermy<br>* Bipolar enucleation of large sized prostate<br>* Other names: Bipolar enucleation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary functional outcomes using uroflowmetry | assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient symptoms | assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9 | 2 years | 
| perioperative complications | assessed by clavien dindo score | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Holmium Laser, Thulium Laser, Bipolar diathermy, prostate enucleation