ProstateNCT07642063
Inverted-T Incision With Early Apical Release vs. Three-Lobe in Holmium Laser Enucleation of The Prostate
A study testing inverted-T with early apical release technique and standard three-lobe technique in people with Prostate and Benign Prostatic Hyperplasia (BPH), run by Benha University at 1 site in Egypt.
Trial summary
Aim of the work is to compare the surgical efficacy and perioperative outcomes of the inverted-T incision with early apical release technique versus the standard three-lobe technique in patients undergoing Holmium Laser Enucleation of The prostate for Benign prostatic hyperplasia . Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate, Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- inverted-T with early apical release technique and standard three-lobe technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2026to 30 Dec 2026
- 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
- Male patients aged 50-80 years.
- Prostate size ≥ 80 mL.
- Candidates for Holmium Laser Enucleation of the Prostate based on clinical and radiological evaluation
Who cannot join
- Suspected or confirmed prostate cancer.
- Previous prostate or urethral procedure (excluding prostate biopsy).
- Urethral stricture.
- Active urinary tract infection.
- Urinary bladder mass, stone or diverticulum.
- Severe coagulopathy or inability to discontinue anticoagulant/antiplatelet medications.
- Unwillingness to comply with follow-up protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Inverted-T Incision With Early Apical Release Technique vs. Three-Lobe Technique in Holmium Laser Enucleation of The Prostate: A Comparative Study
Aim of the work is to compare the surgical efficacy and perioperative outcomes of the inverted-T incision with early apical release technique versus the standard three-lobe technique in patients undergoing Holmium Laser Enucleation of The prostate for Benign prostatic hyperplasia .
Primary outcome :
- Technical operative time (started from the activation of the holmium laser for enucleation of the prostate lobes and ending after completion of morcellation )
Secondary outcome:
- Laser energy used.
- Intraoperative blood loss (change in hemoglobin level).
- Learning curve.
Read the detailed description
Benign prostatic hyperplasia is a histologic diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone.
Treatment options for Benign prostatic hyperplasia range from watchful waiting and lifestyle changes for mild cases to medications that relax smooth muscles of prostatic urethra (alpha-blockers) or decrease the prostate size (5-alpha reductase inhibitors) .
Minimally invasive procedures or surgery (e.g. transurethral resection or anatomical endoscopic enucleation) are the treatment of choice for cases that don't respond to medical treatment and for more severe and complicated symptoms . Tailoring the treatment depends on individual factors like symptom severity, prostate size, age, and tolerance to side effects .
Holmium Laser Enucleation of the Prostate has been established as a gold standard surgical treatment for Benign prostatic hyperplasia of all prostate sizes due to its efficacy, durability, and low complication rates . Holmium Laser Enucleation of the Prostate involves enucleation of the adenoma from the surgical capsule using a holmium laser, followed by morcellation of the enucleated tissue . The standard technique typically involves identifying and dissecting three lobes (median and lateral lobes) .
While effective, the standard three-lobe technique can be technically demanding, particularly in larger glands or those with complex anatomy. Also, it involves multiple incisions which are associated with increased risk of complications. This may lead to longer operating times, increased laser energy usage, and a steeper learning curve .
Various modifications to the standard Holmium Laser Enucleation of the Prostate technique have been proposed to optimize outcomes and simplify the procedure. Inverted-T Incision with Early Apical Release technique aims to simplify the enucleation by creating an inverted T-shaped incision at the bladder neck and then performing early release of the apical attachments. This theoretically allows for easier visualization and dissection of the adenoma and decrease incidence of the sphincter injury, potentially reducing operative time and improving enucleation efficiency.
Although both techniques have shown efficacy in treating Benign prostatic hyperplasia, their comparative effectiveness in terms of enucleation quality, post-operative complications, operative time, and long-term outcomes is still a subject of debate. This study aims to directly compare these two techniques to identify which provides better clinical outcome .
- Conditions
- Prostate, Benign Prostatic Hyperplasia (BPH)
- Being tested
- inverted-T with early apical release technique, standard three-lobe technique
- Keywords
- Benign prostatic hyperplasia, Three-Lobe Technique in Holmium Laser Enucleation of The Prostate, Inverted-T Incision with Early Apical Release Technique
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inverted-T with early apical release techniqueProcedure or surgery
Patients will undergo the inverted-T with early apical release technique. After a full-thickness incision is made at the 12 o'clock position, lateral horizontal incisions are made from the midline towards the sides, expanding the vertical incision to form the "T" shape. Then, early apical release is performed followed by dissection in the posterior plane. After that, the planes are conjoint with continued enucleation until the adenoma is totally separated.
standard three-lobe techniqueProcedure or surgery
Patients will undergo the standard three-lobe technique. After enucleation, adenoma will be morcellated in the bladder using a morcellator device. 3 way urethral catheter will be inserted at the end of the procedure. Laser settings, operative time and blood loss will be recorded for every case.
| Study group | Role | What they receive |
|---|---|---|
| Group A: will undergo the inverted-T with early apical release technique. | Experimental | Patients undergo the inverted-T with early apical release technique Receives: Procedure: inverted-T with early apical release technique |
| Group B: will undergo the standard three-lobe technique | Experimental | Patients undergo the standard three-lobe technique Receives: Procedure: standard three-lobe technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical operative time
Measured: 120 minutes
Secondary outcomes (1)
Intraoperative blood loss
Measured: Intraoperative for 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start20 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- More trials run by Benha 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmonaem Mohamed Elhadey Mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642063
- Sponsor's protocol ID
- MD.1.10.2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it required
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inverted-T Incision With Early Apical Release Technique vs. Three-Lobe Technique in Holmium Laser Enucleation of The Prostate: A Comparative Study
- ClinicalTrials.gov ID
- NCT07642063
- Acronym / sponsor ID
- MD.1.10.2025
- Conditions
- Prostate, Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign prostatic hyperplasia, Three-Lobe Technique in Holmium Laser Enucleation of The Prostate, Inverted-T Incision with Early Apical Release Technique
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Jun 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.
Aim of the work is to compare the surgical efficacy and perioperative outcomes of the inverted-T incision with early apical release technique versus the standard three-lobe technique in patients undergoing Holmium Laser Enucleation of The prostate for Benign prostatic hyperplasia .
Primary outcome :
- Technical operative time (started from the activation of the holmium laser for enucleation of the prostate lobes and ending after completion of morcellation )
Secondary outcome:
- Laser energy used.
- Intraoperative blood loss (change in hemoglobin level).
- Learning curve.
Detailed description
Benign prostatic hyperplasia is a histologic diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone.
Treatment options for Benign prostatic hyperplasia range from watchful waiting and lifestyle changes for mild cases to medications that relax smooth muscles of prostatic urethra (alpha-blockers) or decrease the prostate size (5-alpha reductase inhibitors) .
Minimally invasive procedures or surgery (e.g. transurethral resection or anatomical endoscopic enucleation) are the treatment of choice for cases that don't respond to medical treatment and for more severe and complicated symptoms . Tailoring the treatment depends on individual factors like symptom severity, prostate size, age, and tolerance to side effects .
Holmium Laser Enucleation of the Prostate has been established as a gold standard surgical treatment for Benign prostatic hyperplasia of all prostate sizes due to its efficacy, durability, and low complication rates . Holmium Laser Enucleation of the Prostate involves enucleation of the adenoma from the surgical capsule using a holmium laser, followed by morcellation of the enucleated tissue . The standard technique typically involves identifying and dissecting three lobes (median and lateral lobes) .
While effective, the standard three-lobe technique can be technically demanding, particularly in larger glands or those with complex anatomy. Also, it involves multiple incisions which are associated with increased risk of complications. This may lead to longer operating times, increased laser energy usage, and a steeper learning curve .
Various modifications to the standard Holmium Laser Enucleation of the Prostate technique have been proposed to optimize outcomes and simplify the procedure. Inverted-T Incision with Early Apical Release technique aims to simplify the enucleation by creating an inverted T-shaped incision at the bladder neck and then performing early release of the apical attachments. This theoretically allows for easier visualization and dissection of the adenoma and decrease incidence of the sphincter injury, potentially reducing operative time and improving enucleation efficiency.
Although both techniques have shown efficacy in treating Benign prostatic hyperplasia, their comparative effectiveness in terms of enucleation quality, post-operative complications, operative time, and long-term outcomes is still a subject of debate. This study aims to directly compare these two techniques to identify which provides better clinical outcome .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: will undergo the inverted-T with early apical release technique. | Experimental | Procedure: inverted-T with early apical release techniquePatients undergo the inverted-T with early apical release technique |
| Group B: will undergo the standard three-lobe technique | Experimental | Procedure: standard three-lobe techniquePatients undergo the standard three-lobe technique |
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)
- Male patients aged 50-80 years.
- Prostate size ≥ 80 mL.
- Candidates for Holmium Laser Enucleation of the Prostate based on clinical and radiological evaluation
Key exclusion criteria (7 listed)
- Suspected or confirmed prostate cancer.
- Previous prostate or urethral procedure (excluding prostate biopsy).
- Urethral stricture.
- Active urinary tract infection.
- Urinary bladder mass, stone or diverticulum.
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 |
|---|---|---|
| inverted-T with early apical release techniquePatients will undergo the inverted-T with early apical release technique. After a full-thickness incision is made at the 12 o'clock position, lateral horizontal incisions are made from the midline towards the sides, expanding the vertical incision to form the "T" shape. Then, early apical release is performed followed by dissection in the posterior plane. After that, the planes are conjoint with continued enucleation until the adenoma is totally separated. | Procedure or surgery | Group A: will undergo the inverted-T with early apical release technique. |
| standard three-lobe techniquePatients will undergo the standard three-lobe technique. After enucleation, adenoma will be morcellated in the bladder using a morcellator device. 3 way urethral catheter will be inserted at the end of the procedure. Laser settings, operative time and blood loss will be recorded for every case. | Procedure or surgery | Group B: will undergo the standard three-lobe technique |
Primary outcome
Technical operative time
Time frame: 120 minutes
1 secondary outcome
Intraoperative blood loss
Time frame: Intraoperative for 2 hours
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 11 Jun 2026.
- Individual participant dataSharing planned: Yes. It will be available if it required
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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.
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 inverted-T with early apical release technique and standard three-lobe technique in people with Prostate and Benign Prostatic Hyperplasia (BPH), run by Benha 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 7 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: enrolling by invitation, as of the sponsor's last update on 11 Jun 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?
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?
Technical operative time (time frame: 120 minutes). 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 11 Jun 2026.