Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

Study Overview
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Brief Summary
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To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

Detailed Description
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To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).

Official Title
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Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study

Conditions
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Male, BPH With Urinary Obstruction

Intervention / Treatment
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* Procedure: Holmium laser enucleation of the prostate
* Procedure: Bipolar plasma kinetic enucleation of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from LUTS secondary to infravesical obstruction from BPH failed medical treatment International Prostate Symptom Score (IPSS) > 13 a peak urinary flow rate (Qmax) < 15 ml/sec a prostate size ≥ 80 gm Exclusion Criteria: presence of a urethral stricture neurological disorder bladder cancer prostate cancer previous history of bladder neck surgery or TURP

Ages Eligible for Study
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Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HoLEP holmium laser enucleation of the prostate<br>holmium laser enucleation of the prostate | Procedure: Holmium laser enucleation of the prostate<br>* cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)<br>* Other names: HoLEP;|
| Active Comparator: BPEP bipolar plasmakinetic enucleation of the prostate<br>bipolar plasmakinetic enucleation of the prostate | Procedure: Bipolar plasma kinetic enucleation of the prostate<br>* cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)<br>* Other names: BPEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin drop postoperatively (gm/dL) | difference in hemoglobin concentration postoperatively vs preoperatively | Immediate postoperatively | 
| operative time | operative time in minutes | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications (%) | intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention. | one year | 
| urine flow | Qmax (ml/s), | one year | 
| post-voiding residual urine | postvoiding residual urine (ml) | one year | 
| International prostate symptom score (IPSS) | an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom | one year | 
| Quality of life (QoL) section of International prostate symptom score (IPSS) | one question scored from 0 up to 6 (6 is worst) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, enucleation, Prostate, LUTS, IPSS, quality of life, Large prostate