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NCT Number: NCT07749794

Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location contact

Saad A Salama, MD

CONTACT

[email protected]

01063006039 ext. +2

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection

Procedure

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

Procedure

Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.

Primary outcomes

  1. Intraoperative Blood Loss

    Time frame: 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.

Secondary outcomes

  1. Operative Time

    Time frame: Intraoperatively

    Operative time will be measured in minutes from insertion of the resectoscope until completion of urethral catheter placement.

  2. Enucleated Prostatic Tissue Weight

    Time frame: Immediately after tissue retrieval, intraoperatively

    The removed prostatic adenomatous tissue will be weighed in grams.

  3. Length of Hospital Stay

    Time frame: From completion of surgery until hospital discharge, assessed up to 7 days

    The duration of hospitalization will be measured in hours from completion of surgery until hospital discharge.

  4. Urethral Catheterization Duration

    Time frame: From completion of surgery until catheter removal, assessed up to 7 days

    The duration of postoperative urethral catheterization will be measured in hours from catheter placement at the end of surgery until catheter removal.

  5. Change in Maximum Urinary Flow Rate

    Time frame: At baseline and at 1, 3, and 6 months after surgery

    Maximum urinary flow rate will be measured by uroflowmetry in mL/second. Values obtained after surgery will be compared with the preoperative baseline value.

  6. Change in Post-Void Residual Urine Volume

    Time frame: At baseline and at 1, 3, and 6 months after surgery

    Post-void residual urine volume will be measured by ultrasonography in milliliters. Values obtained after surgery will be compared with the preoperative baseline value.

  7. Change in International Prostate Symptom Score

    Time frame: At baseline and at 1, 3, and 6 months after surgery

    Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score, ranging from 0 to 35, with higher scores indicating more severe symptoms. Postoperative scores will be compared with the preoperative baseline score.

  8. Incidence of Postoperative Complications

    Time frame: At 1, 3, and 6 months after surgery

    The proportion of participants experiencing postoperative complications will be recorded.

  9. Incidence of Intraoperative Complications

    Time frame: Intraoperatively

    The proportion of participants experiencing intraoperative complications will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Saad A Salama, MD

CONTACT

[email protected]

01063006039 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 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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