Standard HoLEP vs Virtual Basket HoLEP for Treatment of BPH

NCT07816484 | Completed

• 1 other identifier: MS.25.04.3153
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to assess impart of VB-HoLEP in management of BPH

Conditions

BPH/LUTS/Sexual Functions

Keywords

HoLEP

Outcome Measures

Primary Outcomes (1)

• Enucleation effeciency

  calculated by dividing the overall resected prosatate volume by the enucleation time in gm/min.

  6 months

Study Arms (2)

standard HoLEP

ACTIVE COMPARATOR

standard holmium laser enucleation of the prostate for large sized prostate

Procedure: standard Holmium laser enucleation of the prostate

VB-HoLEP

ACTIVE COMPARATOR

Virtual basket holmium laser enucleation of the prostate for large sized prostate

Procedure: Virtual basket Holmium laser enucleation of the prostate

Interventions

standard Holmium laser enucleation of the prostate PROCEDURE

prostate enucleation using holmium laser with laser settings 2J/50Hz

standard HoLEP

Virtual basket Holmium laser enucleation of the prostate PROCEDURE

prostate enucleation using holmium laser with laser settings adjust to virtual basket mode

VB-HoLEP

Eligibility Criteria

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

You may qualify if:

• LUTS secondary to BOO due to BPH with indication for surgical intervention:
• International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8) Peak urinary flow rate (Qmax) \<15 ml/sec with at least 150 ml voided volume or catheterized patients due to acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
• ASA (American society of anesthesiologists) score ≤3. Prostate size as measured by TRUS ≥80 cc.

You may not qualify if:

• Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease Active urinary tract infection (till treated by culture-based antibiotics) Presence of active bladder cancer. Known prostate cancer patients will be excluded preoperatively based on digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
• Patient has had an acute myocardial infarction or open-heart surgery \<180 days prior to the date of informed consent.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mnasoura University

Al Mansurah, Dakahlia Governorate, 35561, Egypt

Location

Related Publications (1)

• Bozzini G, Maltagliati M, Besana U, Berti L, Calori A, Sighinolfi MC, Micali S, Roche JB, Gozen A, Mueller A, Pushkar D, Liatsikos E, Boldini M, Buizza C, Rocco B. Holmium laser enucleation of the prostate with Virtual Basket mode: faster and better control on bleeding. BMC Urol. 2021 Feb 23;21(1):28. doi: 10.1186/s12894-021-00797-5.

  PMID: 33622326 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: July 12, 2025
• Primary Completion: September 8, 2026
• Study Completion: September 8, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)