Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

NCT07749794 · tracked via the Priya Life Science Egypt tracker

Sponsor

Benha University

Phase

Not applicable

Started

2026-08-15

Last updated

2026-08-06

Condition(s) studied

Prostatic HyperplasiaLower Urinary Tract Symptoms

Investigational drug(s) / intervention(s)

Hydrodissection-Assisted Bipolar Prostatic Enucleation-EnucleoresectionConventional Bipolar Prostatic Enucleation-Enucleoresection

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection: Transrectal ultrasound-guided subcapsular injection will be used to create a hydrodissection plane between the prostatic adenoma and capsule before bipolar enucleation-enucleoresection.

Conventional Bipolar Prostatic Enucleation-Enucleoresection: Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.

Study summary

This prospective randomized study will compare two surgical techniques for treating benign prostatic hyperplasia. Participants will be assigned to either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine and methylene blue or conventional bipolar prostatic enucleation-enucleoresection without injection.

The injected mixture is intended to separate the enlarged prostatic tissue from the surgical capsule and reduce bleeding during surgery. The study will evaluate whether the hydrodissection-assisted technique improves operative conditions, surgical outcomes, postoperative recovery, urinary symptoms, and urinary flow compared with the conventional technique.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Benign prostatic hyperplasia. * Prostate volume greater than 60 cc as measured by transrectal ultrasonography. * Moderate-to-severe lower urinary tract symptoms, defined as an International Prostate - Symptom Score of 12 or higher. * Failure of or poor response to medical management. Exclusion Criteria: * History of prostate cancer or suspicious findings on prostate biopsy. * Active urinary tract infection. * Severe cardiovascular, pulmonary, or other systemic comorbidities that contraindicate surgery. * Previous prostate surgery, including transurethral resection of the prostate or open prostatectomy. * Chronic urinary retention associated with neurogenic bladder. Hypersensitivity to norepinephrine or methylene blue.

Primary outcome measure(s)

Intraoperative Blood Loss — Intraoperatively
The estimated volume of blood lost during the operative procedure will be recorded in milliliters and compared between the hydrodissection-assisted and conventional groups.

Trial sites (1)

Facility	City	Region	Status
Benha University Hospital	Banhā	Qalyubia Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07749794 on ClinicalTrials.gov ↗ ← All trials in Egypt