HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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To compare the clinical outcome regarding safety and efficacy between Holmium laser enucleation of the prostate and transurethral resection of the prostate in management of benign prostatic hyperplasia.

Detailed Description
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Benign prostatic hyperplasia (BPH) affects 70% of men older than 70 years and is a significant cause of morbidity in this population. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living. Lower urinary tract symptoms (LUTS) in elderly men are mainly related to an enlarged prostate, the actual link between an enlarged prostate and the onset of symptoms are multifactorial. LUTS include both irritative symptoms in the form of urgency, frequency, nocturnal enuresis and urge incontinence as well as obstructive symptoms comprise hesitancy, weak interrupted stream of urine, incomplete voiding which eventually affect the quality of life (QoL), the main goal of treatment is resolve these symptom. Multiple surgical options are available for management of benign prostatic hyperplasia (BPH) and its associated symptoms. Transurethral resection of the prostate (TURP) and open prostatectomy remain the gold standard surgical management. However, considerable morbidities are associated with both procedures and mainly related to the prostate size. These complications may be either patient or surgically related. The patient's related complications are cardiac arrhythmia, myocardial infarction, pulmonary embolism, exacerbation of previous respiratory disease, deep venous thrombosis and death. The surgical related complication includes bleeding, capsular perforation, urosepsis, incontinence, conversion to open surgery, bladder neck stenosis, redo surgery and transurethral resection syndrome. Clearly, a wide gap existed between simple medical therapy on one hand and TURP on the other hand. This wide gap is coupled with the need for a less morbid alternative to TURP that led to the emergence of various less invasive therapy among which Laser based minimally invasive procedure. Modern laser therapy for BPH has advantages over TURP including decreased blood loss and minimal serum electrolyte changes resulting in fewer cardiovascular complications, decreased catheter time, shorter hospital stay and the ability to treat patients on anticoagulation. Because of these potential advantages, there has been a shift in practice patterns with laser procedures accounting for 57% of surgical interventions for BPH, compared to traditional TURP which accounted for only 39% of interventions in 2005. Holmium laser enucleation of the prostate (HoLEP) is the most recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective surgical procedure, which has comparable results to transurethral resection of the prostate (TURP) and open prostatectomy, with low morbidity and short hospital stay. HoLEP is equally suitable for small, medium, and large prostate glands, with clinical outcomes that are independent of prostate size, and recently it has been proposed as a new gold standard for treatment of symptomatic benign prostatic hyperplasia (BPH). Currently, all BPH guidelines recommend HoLEP as a surgical treatment of BPH. For a procedure to be considered a gold standard, it must provide effective results, low morbidity, and durable outcomes. HoLEP, as many of the new alternative treatments for symptomatic BPH, has scanty data regarding its role in Egyptian population and if it can replace TURP to be the gold standard. To our best knowledge, no one estimated cost effectiveness between the two techniques in a developing country. Our study aimed to compare the efficacy, safety and cost effectiveness of HoLEP versus monopolar TURP in management of benign prostatic hyperplasia in a developing country.

Official Title
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Holmium Laser Enucleation of the Prostate Versus Monopolar Transurethral Resection of the Prostate in Management of Benign Prostatic Hyperplasia.

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Holmium laser enucleation of prostate
* Procedure: monopolar transurethral resection of prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prostate volume less than 80 ml high IPSS more than 19 affecting quality of life recurrent urinary retention with failure of medical treatment recurrent urinary tract infection affection of upper urinary tract refractory hematuria bladder stones bladder diverticula Exclusion Criteria: patients with neurogenic bladder patients with previous prostate or urethral surgery associated urethral stricture prostate cancer diagnosed by TRUS biopsy prostate volume more than 80 ml
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 enucleation of prostate<br>patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure | Procedure: Holmium laser enucleation of prostate<br>* surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation<br>|
| Active Comparator: monopolar transurethral resection of prostate<br>patients that undergo monopolar transurethral resection of prostate | Procedure: monopolar transurethral resection of prostate<br>* surgical management of BPH by monopolar TURP using distilled water for irrigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the international prostate symptom score (IPSS) | assessing the improvement of IPSS | 1 year | 
| maximum urine flow rate (Qmax) | assessing the improvement of Qmax | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | estimating the operative time in both groups in minutes | immediately postoperative | 
| resected volume | measuring the resected volume of prostate after each operation | immediately postoperative | 
| postoperative drop in hemaoglobin level | comparing postoperative hemoglobin level with preoperative level in both groups | 1 day postoperative | 
| postoperative drop in sodium level | comparing postoperative sodium level with preoperative level in both groups | 1 day postoperative | 
| postoperative catheterization time | assessing postoperative catheterization time in both groups | 4 days postoperative | 
| duration of hospital stay | assessing duration of hospital stay in both groups | 3 days postoperative | 
| postvoiding residual urine volume | assessing postvoiding residual urine volume in both groups | 1 year | 
| ultrasound assessed prostate volume | comparing ultrasound assessed prostate volume in both groups | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, transurethral resection of prostate, HoLEP