Skip to content

HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

Holmium Laser Versus Bipolar Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Large Prostates: A Non-inferiority Prospective Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06759194
Enrollment
98
Registered
2025-01-06
Start date
2025-01-01
Completion date
2027-01-01
Last updated
2025-07-24

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

Conditions

Benign Prostatic Hyperplasia

Keywords

Holmium Laser Enucleation of Prostate (HoLEP), Benign Prostatic Hyperplasia (BPH), Bipolar Enucleation of Prostate (BipolEP)

Brief summary

This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

Detailed description

Benign prostatic hyperplasia (BPH) is a prevalent condition among older men. It is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. In case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. Surgical options in such cases include Holmium Laser Enucleation of the Prostate (HoLEP) and Bipolar Enucleation of the Prostate (BipolEP). These modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. HoLEP, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. Likewise, BipolEP, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. Both HoLEP and BipolEP have demonstrated efficacy in improving lower urinary tract symptoms (LUTS) and alleviating obstruction in BPH patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. This study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in BPH management.

Interventions

Enucleation of the prostate gland using holmium laser energy

Enucleation of the prostate gland using bipolar energy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>50 years * Prostate volume \>80 ml * Failure of or noncompliance with medical treatment * IPSS \>15 * Qmax \<15 ml/sec * Urinary retention and fixed catheters with poor results on trial of voiding without catheter

Exclusion criteria

* Patients with active UTI * Prostate cancer * Bladder carcinoma * Urethral stricture * Neurogenic bladder disorders * Redo cases

Design outcomes

Primary

MeasureTime frameDescription
Change in peak flow rateAt 6 months after the procedure (HoLEP or BipolEP)Treatment efficacy will be evaluated by comparing the change in peak flow rate (Qmax) on uroflowmetry between the two groups

Secondary

MeasureTime frameDescription
ComplicationsAt 6 months after the procedure (HoLEP or BipolEP)Treatment safety will be evaluated by collecting and analyzing any reported complication within the first 6 postoperative months. Complications will be reported using the modified Clavien-Dindo classification system.

Countries

Egypt

Contacts

Primary ContactMostafa M. Mostafa, M.D.
mostafaabdelaziz91@gmail.com+201000740478
Backup ContactMohammad A. Abd ElMoneim, M.D.
mohamed.20134296@med.aun.edu.eg+201028511082

Outcome results

None listed

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