HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

NCT06759194 | Recruiting

• 1 other identifier: HoLEP vs BipolEP
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Prostatic Hyperplasia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in peak flow rate

  Treatment efficacy will be evaluated by comparing the change in peak flow rate (Qmax) on uroflowmetry between the two groups

  At 6 months after the procedure (HoLEP or BipolEP)

Secondary Outcomes (1)

• Complications

  At 6 months after the procedure (HoLEP or BipolEP)

Study Arms (2)

Holmium Laser Enucleation of the Prostate (HoLEP)

ACTIVE COMPARATOR

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

Procedure: Holmium Laser Enucleation of the Prostate

Bipolar Enucleation of the Prostate (BipolEP)

ACTIVE COMPARATOR

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

Procedure: Bipolar Enucleation of the Prostate

Interventions

Holmium Laser Enucleation of the Prostate PROCEDURE

Enucleation of the prostate gland using holmium laser energy

Holmium Laser Enucleation of the Prostate (HoLEP)

Bipolar Enucleation of the Prostate PROCEDURE

Enucleation of the prostate gland using bipolar energy

Bipolar Enucleation of the Prostate (BipolEP)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Urology Hospital

Asyut, Egypt

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mostafa M. Mostafa, M.D.

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa M. Mostafa, M.D.

CONTACT

+201000740478; mostafaabdelaziz91@gmail.com

Mohammad A. Abd ElMoneim, M.D.

CONTACT

+201028511082; mohamed.20134296@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)