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CompletedNCT07816484VB-HOLEPUpdated Sep 11, 2026

Standard HoLEP vs Virtual Basket HoLEP for Treatment of BPH

An interventional study of standard Holmium laser enucleation of the prostate and Virtual basket Holmium laser enucleation of the prostate in BPH/LUTS/Sexual Functions, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study summary

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

Read the detailed description

The aim of this study is to evaluate safety and efficacy of pulse modulated HoLEP compared to Standard HoLEP as regard sexual and urinary outcomes

02

Conditions studied

  • BPH/LUTS/Sexual Functions

Keywords

  • HoLEP
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
133 participants (actual)

Study arms

  • Active comparator
    standard HoLEP

    standard holmium laser enucleation of the prostate for large sized prostate

    Procedure: standard Holmium laser enucleation of the prostate

  • Active comparator
    VB-HoLEP

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

    Procedure: Virtual basket Holmium laser enucleation of the prostate

Interventions

  • Procedurestandard Holmium laser enucleation of the prostate

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

  • ProcedureVirtual basket Holmium laser enucleation of the prostate

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

05

What researchers measure

Primary outcomes

  1. Enucleation effeciency

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

    Time frame: 6 months

06

Study locations

1 site
  • Urology and Nephrology Center, Mnasoura University
    Al Mansurah, Dakahlia Governorate 35561, Egypt
07

References and documents

Publications

  • 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. PubMed 33622326 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07816484
Lead sponsor
Mansoura University
Responsible party
Ahmed Abolazm (Consultant, Mansoura University) — Principal investigator
First posted
Sep 11, 2026
Start date
Jul 12, 2025
Primary completion
Sep 8, 2026
Completion
Sep 8, 2026
Last update
Sep 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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