BPH/LUTS/Sexual FunctionsVB-HOLEPNCT07816484
Standard HoLEP vs Virtual Basket HoLEP for Treatment of BPH
A study testing standard Holmium laser enucleation of the prostate and Virtual basket Holmium laser enucleation of the prostate in people with BPH/LUTS/Sexual Functions, run by Mansoura University at 1 site in Egypt.
Trial summary
We aimed to assess impart of VB-HoLEP in management of BPH Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH/LUTS/Sexual Functions
- What is being tested?
- standard Holmium laser enucleation of the prostate and Virtual basket Holmium laser enucleation of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2025to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and Nephrology Center, Mnasoura University
Al Mansurah, Dakahlia Governorate, 35561
About this study
Official title: Standard Versus Virtual Basket Holmium:Yag Laser Enucleation of Prostate in Treatment of Symptomatic Benign Prostatic Hyperplasia. A Randomized Controlled Trial.
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
- Conditions
- BPH/LUTS/Sexual Functions
- Being tested
- standard Holmium laser enucleation of the prostate, Virtual basket Holmium laser enucleation of the prostate
- Keywords
- HoLEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard Holmium laser enucleation of the prostateProcedure or surgery
prostate enucleation using holmium laser with laser settings 2J/50Hz
Virtual basket Holmium laser enucleation of the prostateProcedure or surgery
prostate enucleation using holmium laser with laser settings adjust to virtual basket mode
| Study group | Role | What they receive |
|---|---|---|
| standard HoLEP | Active comparator | standard holmium laser enucleation of the prostate for large sized prostate Receives: Procedure: standard Holmium laser enucleation of the prostate |
| VB-HoLEP | Active comparator | Virtual basket holmium laser enucleation of the prostate for large sized prostate Receives: Procedure: Virtual basket Holmium laser enucleation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enucleation effeciency
calculated by dividing the overall resected prosatate volume by the enucleation time in gm/min.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start12 Jul 2025
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPH/LUTS/Sexual FunctionsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abolazm, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816484
- Sponsor's protocol ID
- MS.25.04.3153
- Acronym
- VB-HOLEP
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Virtual Basket Holmium:Yag Laser Enucleation of Prostate in Treatment of Symptomatic Benign Prostatic Hyperplasia. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07816484
- Acronym / sponsor ID
- VB-HOLEP / MS.25.04.3153
- Conditions
- BPH/LUTS/Sexual Functions
- Keywords
- HoLEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Jul 2025 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard HoLEP | Active comparator | Procedure: standard Holmium laser enucleation of the prostatestandard holmium laser enucleation of the prostate for large sized prostate |
| VB-HoLEP | Active comparator | Procedure: Virtual basket Holmium laser enucleation of the prostateVirtual basket holmium laser enucleation of the prostate for large sized prostate |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard Holmium laser enucleation of the prostateprostate enucleation using holmium laser with laser settings 2J/50Hz | Procedure or surgery | standard HoLEP |
| Virtual basket Holmium laser enucleation of the prostateprostate enucleation using holmium laser with laser settings adjust to virtual basket mode | Procedure or surgery | VB-HoLEP |
Primary outcome
Enucleation effeciency
Time frame: 6 months
calculated by dividing the overall resected prosatate volume by the enucleation time in gm/min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 33622326Bozzini 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard Holmium laser enucleation of the prostate and Virtual basket Holmium laser enucleation of the prostate in people with BPH/LUTS/Sexual Functions, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enucleation effeciency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07816484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.