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Recruiting NCT06759194

HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

No phase Interventional Benign Prostatic Hyperplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Holmium Laser Enucleation of the Prostate, Bipolar Enucleation of the Prostate.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Procedure Holmium Laser Enucleation of the Prostate
    Enucleation of the prostate gland using holmium laser energy
  • Procedure Bipolar Enucleation of the Prostate
    Enucleation of the prostate gland using bipolar energy

Primary outcome measures

  • Change in peak flow rate [Time frame: At 6 months after the procedure (HoLEP or BipolEP)]
Secondary outcome measures (1)
  • Complications [Time frame: At 6 months after the procedure (HoLEP or BipolEP)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut University Urology Hospital — Asyut

Publications

  • Becker B, Herrmann TRW, Gross AJ, Netsch C. Thulium vapoenucleation of the prostate versus holmium laser enucleation of the prostate for the treatment of large volume prostates: preliminary 6-month safety and efficacy results of a prospective randomized trial. World J Urol. 2018 Oct;36(10):1663-1671. doi: 10.1007/s00345-018-2321-8. Epub 2018 May 5. PMID 29730838
  • Tan AH, Gilling PJ. Holmium laser prostatectomy: current techniques. Urology. 2002 Jul;60(1):152-6. doi: 10.1016/s0090-4295(02)01648-5. PMID 12100945
  • Neill MG, Gilling PJ, Kennett KM, Frampton CM, Westenberg AM, Fraundorfer MR, Wilson LC. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006 Nov;68(5):1020-4. doi: 10.1016/j.urology.2006.06.021. Epub 2006 Nov 7. PMID 17095078
  • Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28. PMID 37667842

Identifiers

NCT: NCT06759194 · HoLEP vs BipolEP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗