HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

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

Detailed Description
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To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).

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

Conditions
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BPH With Urinary Obstruction, Male

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 failed medical treatment International Prostate Symptom Score (IPSS) > 13 a peak urinary flow rate (Qmax) < 15 ml/sec a prostate size ≥ 75 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 (Versa pulse 100W; Lumenis; Germany)<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) | difference in hemoglobin concentration postoperatively vs preoperatively | Immediate postoperatively | 
| operative duration in minutes | operative duration | during surgery | 
| Hospital stay in days | Hospital stay | immediately after 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. | Two years | 
| urine flow | Qmax (ml/s), | Two years | 
| post-voiding residual urine | postvoiding residual urine (ml) | Two years | 
| 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 | Two years | 
| Quality of life (QoL) | section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst) | Two years | 
| Catheter duration | Catheter duration in hours | immediate postoperatively | 

 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