HoLEP vs mTURP in Management of Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Procedure: Holmium laser enucleation of prostate; Procedure: monopolar transurethral resection of prostate

• Registration Number: NCT04561505
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-29
• Status Verified: 2020-09
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Holmium laser enucleation of prostate	Holmium laser enucleation of prostate	patients that undergo Holmium laser enucleation of prostate (HoLEP) procedure
monopolar transurethral resection of prostate	monopolar transurethral resection of prostate	patients that undergo monopolar transurethral resection of prostate

Primary Outcome Measures

Name	Time	Method
maximum urine flow rate (Qmax)	1 year	assessing the improvement of Qmax
the international prostate symptom score (IPSS)	1 year	assessing the improvement of IPSS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ainshams university hospital; 🇪🇬 Cairo, Egypt