HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

NCT ID: NCT06759194

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-01-01

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Holmium Laser Enucleation of the Prostate (HoLEP)

Half of the BPH patients with large prostate admitted to the study will undergo Holmium Laser Enucleation of the Prostate (HoLEP)

Group Type: ACTIVE_COMPARATOR

Holmium Laser Enucleation of the Prostate

Intervention Type: PROCEDURE

Enucleation of the prostate gland using holmium laser energy

Bipolar Enucleation of the Prostate (BipolEP)

Half of the BPH patients with large prostate admitted to the study will undergo Bipolar Enucleation of the Prostate (BipolEP)

Group Type: ACTIVE_COMPARATOR

Bipolar Enucleation of the Prostate

Intervention Type: PROCEDURE

Enucleation of the prostate gland using bipolar energy

Interventions

Holmium Laser Enucleation of the Prostate

Enucleation of the prostate gland using holmium laser energy

Intervention Type: PROCEDURE

Bipolar Enucleation of the Prostate

Enucleation of the prostate gland using bipolar energy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Mohamed Atef Abdelaziz Mostafa

Lecturer of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa M. Mostafa, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University Urology Hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mostafa M. Mostafa, M.D.

Role: CONTACT

mostafaabdelaziz91@gmail.com

+201000740478

Mohammad A. Abd ElMoneim, M.D.

Role: CONTACT

mohamed.20134296@med.aun.edu.eg

+201028511082

Facility Contacts

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

Role: primary

mostafaabdelaziz91@gmail.com

1000740478 ext. 20

References

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.

Reference Type: BACKGROUND

PMID: 29730838 (View on PubMed)

Tan AH, Gilling PJ. Holmium laser prostatectomy: current techniques. Urology. 2002 Jul;60(1):152-6. doi: 10.1016/s0090-4295(02)01648-5.

Reference Type: BACKGROUND

PMID: 12100945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17095078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37667842 (View on PubMed)

Other Identifiers

HoLEP vs BipolEP

Identifier Type: -

Identifier Source: org_study_id