HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

Study Overview
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Brief Summary
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To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)

Detailed Description
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To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 gm)

Official Title
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Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial

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 resection 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 with 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: 45 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: holmium laser enucleation of the prostate<br>holmium laser enucleation of the prostate (HoLEP) | Procedure: holmium laser enucleation of the prostate<br>* cystoscopic transurethral enucleation of the prostate using Holmium laser<br>* Other names: HoLEP;|
| Active Comparator: bipolar resection of the prostate<br>bipolar resection of the prostate (BPEP) | Procedure: Bipolar resection of the prostate<br>* cystoscopic transurethral resection of the prostate using bipolar energy<br>* Other names: BPRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin drop postoperatively (gm/dL) | change in hemoglobin concentration postoperatively vs preoperatively | within two hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative duration in minutes | operative duration | Time lapsed during surgery | 
| Hospital stay | Hospitalisation starting from day of surgery till the day of discharge from Hospital in days | From time of randomisation up to last day of admission in hospital (in days) up to 30 days | 
| blood transfusion | rate of blood transfusion | during surgery and hospitalisation up to 10 days | 

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