Benign Prostatic Hyperplasia With Outflow ObstructionNCT07890103
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
A study testing Tri-lobar HoLEP and En-bloc HoLEP in people with Benign Prostatic Hyperplasia With Outflow Obstruction, run by Tanta University at 1 site in Egypt.
Trial summary
Several HoLEP techniques have been developed, with the conventional tri-lobar and the en-bloc approaches being the most commonly practiced. Although both techniques achieve comparable functional outcomes and safety profiles, they differ in surgical dissection strategy and anatomical orientation. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia With Outflow Obstruction
- What is being tested?
- Tri-lobar HoLEP and En-bloc HoLEP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BPH requiring HoLEP
- Prostate 80-150 cc
- Performed by surgeons with no previous independent experience in the evaluated techniques
Who cannot join
- Previous prostate surgery
- Neurogenic bladder
- Prostate cancer
- Simultaneous bladder surgery
- Extremely large prostates (>150 cc)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Tanta University
Tanta
Mahmoud Mohamed Elrefaey, Lecturer of Urology, +201283625007, mahmoud.elrefaey@med.tanta.edu.eg
About this study
Official title: Comparison of the Learning Curves of Tri-lobar Versus En-bloc Holmium Laser Enucleation of the Prostate: A Prospective Randomized Clinical Trial
Several HoLEP techniques have been developed, with the conventional tri-lobar and the en-bloc approaches being the most commonly practiced. Although both techniques achieve comparable functional outcomes and safety profiles, they differ in surgical dissection strategy and anatomical orientation. Some authors suggest that the en-bloc technique may facilitate maintenance of the correct surgical plane, whereas others consider the tri-lobar approach easier for surgeons familiar with transurethral resection of the prostate (TURP). However, evidence comparing their learning characteristics remains limited.
Most published studies evaluating the HoLEP learning curve have investigated a single surgical technique or assessed a second technique after surgeons had already gained substantial HoLEP experience. Such study designs introduce significant bias because increasing surgical experience inevitably influences subsequent performance.
A prospective alternating design, in which a HoLEP-naïve surgeon performs consecutive tri-lobar and en-bloc procedures, may provide a more balanced comparison by exposing both techniques to similar levels of cumulative surgical experience while minimizing temporal bias.
- Being tested
- Tri-lobar HoLEP, En-bloc HoLEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-lobar HoLEPProcedure or surgery
endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as 3 specimens (median lobe and 2 lateral lobes) using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser
En-bloc HoLEPProcedure or surgery
endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as a single, intact specimen using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser
| Study group | Role | What they receive |
|---|---|---|
| Tri-lobar HoLEP | Other | Not described Receives: Procedure: Tri-lobar HoLEP |
| En-bloc HoLEP | Experimental | Not described Receives: Procedure: En-bloc HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases required to achieve procedural proficiency
Number of cases required to achieve procedural proficiency, defined by a sustained plateau in enucleation efficiency (enucleated weight in gm/operative time in min) determined using RA-CUSUM.
Risk-adjusted CUSUM adjusts for:
- Prostate size
- Operative time (Enucleation time + Morcellation time)
- Enucleated weight
Measured: 1 year
Secondary outcomes (3)
Enucleation time
Measured: 1 year
Morcellation time
Measured: 1 year
Enucleated weight
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia With Outflow ObstructionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elrefaey, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890103
- Sponsor's protocol ID
- 36265PR227/9/26
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Learning Curves of Tri-lobar Versus En-bloc Holmium Laser Enucleation of the Prostate: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07890103
- Acronym / sponsor ID
- 36265PR227/9/26
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Oct 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.
Several HoLEP techniques have been developed, with the conventional tri-lobar and the en-bloc approaches being the most commonly practiced. Although both techniques achieve comparable functional outcomes and safety profiles, they differ in surgical dissection strategy and anatomical orientation. Some authors suggest that the en-bloc technique may facilitate maintenance of the correct surgical plane, whereas others consider the tri-lobar approach easier for surgeons familiar with transurethral resection of the prostate (TURP). However, evidence comparing their learning characteristics remains limited.
Most published studies evaluating the HoLEP learning curve have investigated a single surgical technique or assessed a second technique after surgeons had already gained substantial HoLEP experience. Such study designs introduce significant bias because increasing surgical experience inevitably influences subsequent performance.
A prospective alternating design, in which a HoLEP-naïve surgeon performs consecutive tri-lobar and en-bloc procedures, may provide a more balanced comparison by exposing both techniques to similar levels of cumulative surgical experience while minimizing temporal bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tri-lobar HoLEP | Other | Procedure: Tri-lobar HoLEP |
| En-bloc HoLEP | Experimental | Procedure: En-bloc HoLEP |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BPH requiring HoLEP
- Prostate 80-150 cc
- Performed by surgeons with no previous independent experience in the evaluated techniques
Key exclusion criteria (5 listed)
- Previous prostate surgery
- Neurogenic bladder
- Prostate cancer
- Simultaneous bladder surgery
- Extremely large prostates (>150 cc)
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 |
|---|---|---|
| Tri-lobar HoLEPendoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as 3 specimens (median lobe and 2 lateral lobes) using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser | Procedure or surgery | Tri-lobar HoLEP |
| En-bloc HoLEPendoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as a single, intact specimen using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser | Procedure or surgery | En-bloc HoLEP |
Primary outcome
Number of cases required to achieve procedural proficiency
Time frame: 1 year
Number of cases required to achieve procedural proficiency, defined by a sustained plateau in enucleation efficiency (enucleated weight in gm/operative time in min) determined using RA-CUSUM. Risk-adjusted CUSUM adjusts for: * Prostate size * Operative time (Enucleation time + Morcellation time) * Enucleated weight
3 secondary outcomes
Enucleation time
Time frame: 1 year
Morcellation time
Time frame: 1 year
Enucleated weight
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tri-lobar HoLEP and En-bloc HoLEP in people with Benign Prostatic Hyperplasia With Outflow Obstruction, run by Tanta 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 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases required to achieve procedural proficiency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.