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NCT Number: NCT06759194

HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

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

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Urology Hospital

Asyut, Egypt

Location status: Recruiting

Location contact

Mostafa M Mostafa, M.D., M.Sc. Urology, Ph.D. Uro

CONTACT

[email protected]

1000740478 ext. 20

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

holmium laser enucleation of the prostate

Procedure

Enucleation of the prostate gland using holmium laser energy

Bipolar enucleation of the prostate

Procedure

Enucleation of the prostate gland using bipolar energy

Primary outcomes

  1. Change in peak flow rate

    Time frame: At 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 outcomes

  1. Complications

    Time frame: At 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad A. Abd ElMoneim, M.D.

CONTACT

[email protected]

+201028511082

Mostafa M. Mostafa, M.D.

CONTACT

[email protected]

+201000740478

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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