Inverted-T Incision With Early Apical Release vs. Three-Lobe in Holmium Laser Enucleation of The Prostate

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Benign Prostatic Hyperplasia (BPH); Prostate
• Intervention / Treatment: Procedure: inverted-T with early apical release technique; Procedure: standard three-lobe technique

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patients aged 50-80 years.
• Prostate size ≥ 80 mL.
• Candidates for Holmium Laser Enucleation of the Prostate based on clinical and radiological evaluation

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: will undergo the inverted-T with early apical release technique.; Patients undergo the inverted-T with early apical release technique	Procedure: inverted-T with early apical release technique; 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.
Experimental: Group B: will undergo the standard three-lobe technique; Patients undergo the standard three-lobe technique	Procedure: standard three-lobe technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Technical operative time	120 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Intraoperative blood loss	Intraoperative for 2 hours

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Benign prostatic hyperplasia; Three-Lobe Technique in Holmium Laser Enucleation of The Prostate; Inverted-T Incision with Early Apical Release Technique
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: MD.1.10.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be available if it required
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No