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

NCT07642063 | Enrolling By Invitation

• 1 other identifier: MD.1.10.2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 . 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.

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

Outcome Measures

Primary Outcomes (1)

• Technical operative time

  120 minutes

Secondary Outcomes (1)

• Intraoperative blood loss

  Intraoperative for 2 hours

Study Arms (2)

Group A: will undergo the inverted-T with early apical release technique.

EXPERIMENTAL

Patients undergo the inverted-T with early apical release technique

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

Procedure: standard three-lobe technique

Interventions

inverted-T with early apical release technique PROCEDURE

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.

Group A: will undergo the inverted-T with early apical release technique.

standard three-lobe technique PROCEDURE

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.

Group B: will undergo the standard three-lobe technique

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Specialist, Ministry of Health

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: June 11, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)