HoLEP Vs BPEP for Large Prostatic Adenoma

Study Overview
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Brief Summary
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Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living. At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure. Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy

Detailed Description
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Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL). Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes. Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy. EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy. Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries. With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.

Official Title
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Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial

Conditions
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Prostate Hyperplasia

Intervention / Treatment
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* Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including: Bothersome LUTS with an IPSS score over 19 Refractory hematuria Upper urinary tract affection Recurrent UTI secondary to prostatic enlargement Maximum uroflow rate (Qmax) below 10 ml/sec. bladder diverticula Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention. Exclusion Criteria: Patients with: Neurogenic bladder Previous prostate or urethral surgery Associated urethral stricture Prostate cancer diagnosed by TRUS biopsy Bladder stones,
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 |
| --- | --- |
| Experimental: Holmium laser enucleation of the prostate<br>Holmium laser enucleation of the prostate | Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia<br>* comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate<br>|
| Experimental: bipolar transurethral enucleation of the prostate<br>bipolar transurethral enucleation of the prostate | Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia<br>* comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | form the beginning of endoscopic procedure till catheter insertion | 50-120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enucleation efficacy of HoLEP | Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams | 12 months | 
| Enucleation efficacy of BEEP | Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams | 12 months | 
| Mean energy in (HoLEP) in joules | Mean energy in (HoLEP) in joules | intra-operative finding | 
| irrigation fluid | Average Irrigation fluid used in each group in liters | intra-operative finding | 
| catheter removal time | postoperative time till catheter removal | 1-7 days | 
| resected volume | resected volume in grams | intra-operative finding | 
| hemoglobin drop | blood loss in dl/ml | intra-operative finding | 
| conversion to other type of surgery | conversion to other types of surgeries like TURP, open surgery, procedure abortion | intra-operative finding | 
| Operative safety: | capsular perforation, Yes/No | intra-operative finding | 
| Operative safety: | morcellation injury, Yes/No | intra-operative finding | 
| early post operative complication | stress incontinence, Yes/No | 1 month | 
| early post operative complication | urinary tract infection, Yes/No | 1 month | 
| early post operative complication | urine retention, Yes/No | 1 month | 
| Postoperative efficacy: | IPSS: international prostate symptom score | 12 months | 
| Postoperative efficacy: | QoL: quality of life questionnaire | 12 months | 
| Postoperative efficacy: | Qmax (m/sec.) : peak flow rate | 12 months | 
| Postoperative efficacy: | PVRU (ml): post voiding residual urine | 12 months | 
| Postoperative efficacy: | PSA (ng/ml): prostatic specific antigen | 12 months | 
| Postoperative efficacy: | postoperative prostate volume assessment in grams | 12 months | 
| cost effectiveness | Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group | 12 months | 
| hospital stay | duration of postoperative hospital stay in days | 1-7 days | 
| Cost analysis | average running cost evaluation in both procedure | 1 year |