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Not yet recruiting NCT07749794

Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

No phase Interventional Prostatic Hyperplasia Lower Urinary Tract Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection, Conventional Bipolar Prostatic Enucleation-Enucleoresection.
Who it may be relevant to
Registry conditions: Prostatic Hyperplasia, Lower Urinary Tract Symptoms. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection With Subcapsular Injection of Diluted Norepinephrine-Methylene Blue Mixture Versus Conventional Bipolar Prostatic Enucleation-Enucleoresection: A Prospective Randomized Comparative Study

Overview

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.

Interventions

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

Primary outcome measures

  • Intraoperative Blood Loss [Time frame: Intraoperatively]
Secondary outcome measures (9)
  • Operative Time [Time frame: Intraoperatively]
  • Enucleated Prostatic Tissue Weight [Time frame: Immediately after tissue retrieval, intraoperatively]
  • Length of Hospital Stay [Time frame: From completion of surgery until hospital discharge, assessed up to 7 days]
  • Urethral Catheterization Duration [Time frame: From completion of surgery until catheter removal, assessed up to 7 days]
  • Change in Maximum Urinary Flow Rate [Time frame: At baseline and at 1, 3, and 6 months after surgery]
  • Change in Post-Void Residual Urine Volume [Time frame: At baseline and at 1, 3, and 6 months after surgery]
  • Change in International Prostate Symptom Score [Time frame: At baseline and at 1, 3, and 6 months after surgery]
  • Incidence of Postoperative Complications [Time frame: At 1, 3, and 6 months after surgery]
  • Incidence of Intraoperative Complications [Time frame: Intraoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Benha University Hospital — Banhā

Identifiers

NCT: NCT07749794 · RC.8.1.2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗