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Enrolling by Invitation

NCT Number: NCT07642063

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Technical operative time

    Time frame: 120 minutes

Secondary outcomes

  1. Intraoperative blood loss

    Time frame: Intraoperative for 2 hours

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Inverted-T Incision With Early Apical Release Technique vs. Three-Lobe Technique in Holmium Laser Enucleation of The Prostate: A Comparative Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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