Clinical trial NCT04275076: HoLEP Vs BPEP for Large Prostatic Adenoma
Official title: Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Hyperplasia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:

  1. Bothersome LUTS with an IPSS score over 19
  2. Refractory hematuria
  3. Upper urinary tract affection
  4. Recurrent UTI secondary to prostatic enlargement
  5. Maximum uroflow rate (Qmax) below 10 ml/sec.
  6. bladder diverticula
  7. Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.

Exclusion Criteria:

* Patients with:

  1. Neurogenic bladder
  2. Previous prostate or urethral surgery
  3. Associated urethral stricture
  4. Prostate cancer diagnosed by TRUS biopsy
  5. Bladder stones,

Primary outcomes:
measure: operative time
timeFrame: 50-120 minutes
Secondary outcomes:
measure: Enucleation efficacy of HoLEP
timeFrame: 12 months
measure: Enucleation efficacy of BEEP
timeFrame: 12 months
measure: Mean energy in (HoLEP) in joules
timeFrame: intra-operative finding
measure: irrigation fluid
timeFrame: intra-operative finding
measure: catheter removal time
timeFrame: 1-7 days
measure: resected volume
timeFrame: intra-operative finding
measure: hemoglobin drop
timeFrame: intra-operative finding
measure: conversion to other type of surgery
timeFrame: intra-operative finding
measure: Operative safety:
timeFrame: intra-operative finding
measure: Operative safety:
timeFrame: intra-operative finding
measure: early post operative complication
timeFrame: 1 month
measure: early post operative complication
timeFrame: 1 month
measure: early post operative complication
timeFrame: 1 month
measure: Postoperative efficacy:
timeFrame: 12 months
measure: Postoperative efficacy:
timeFrame: 12 months
measure: Postoperative efficacy:
timeFrame: 12 months
measure: Postoperative efficacy:
timeFrame: 12 months
measure: Postoperative efficacy:
timeFrame: 12 months
measure: Postoperative efficacy:
timeFrame: 12 months
measure: cost effectiveness
timeFrame: 12 months
measure: hospital stay
timeFrame: 1-7 days
measure: Cost analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References: