Standard HoLEP vs Virtual Basket HoLEP for Treatment of BPH

Standard Versus Virtual Basket Holmium:Yag Laser Enucleation of Prostate in Treatment of Symptomatic Benign Prostatic Hyperplasia. A Randomized Controlled Trial.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07816484

Acronym

VB-HOLEP

Enrollment

133

Registered

2026-09-11

Start date

2025-07-12

Completion date

2026-09-08

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH/LUTS/Sexual Functions

Keywords

HoLEP

Brief summary

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

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. \-

Design outcomes

Primary

Measure	Time frame	Description
Enucleation effeciency	6 months	calculated by dividing the overall resected prosatate volume by the enucleation time in gm/min.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026