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HoLEP Vs BPEP for Large Prostatic Adenoma

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04275076
Acronym
enucleation
Enrollment
100
Registered
2020-02-19
Start date
2018-02-01
Completion date
2020-02-01
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Hyperplasia

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.

Interventions

PROCEDUREHolmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia

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

Sponsors

Ahmed Maher Gamil Ahmed Higazy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

patients, data collector, and the statistician all were blinded to the type of intervention that was used in each group.

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
operative time50-120 minutesform the beginning of endoscopic procedure till catheter insertion

Secondary

MeasureTime frameDescription
Enucleation efficacy of BEEP12 monthsMean Enucleation time (BPEP) in minutes/ Mean resected volume in grams
Mean energy in (HoLEP) in joulesintra-operative findingMean energy in (HoLEP) in joules
irrigation fluidintra-operative findingAverage Irrigation fluid used in each group in liters
catheter removal time1-7 dayspostoperative time till catheter removal
resected volumeintra-operative findingresected volume in grams
hemoglobin dropintra-operative findingblood loss in dl/ml
Enucleation efficacy of HoLEP12 monthsMean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams
Operative safety:intra-operative findingcapsular perforation, Yes/No
early post operative complication1 monthstress incontinence, Yes/No
Postoperative efficacy:12 monthsIPSS: international prostate symptom score
cost effectiveness12 monthsRunning cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group
hospital stay1-7 daysduration of postoperative hospital stay in days
Cost analysis1 yearaverage running cost evaluation in both procedure
conversion to other type of surgeryintra-operative findingconversion to other types of surgeries like TURP, open surgery, procedure abortion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026