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NCT07749794Not yet recruiting

Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

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

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
3 Aug 2026
Start date
15 Aug 2026
Primary completion date
15 Aug 2027
Lead sponsor
Benha University
NCT number
NCT07749794

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 15 Aug 2026 to the primary completion date, 15 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe cardiovascular, pulmonary, or other systemic comorbidities that contraindicate surgery.
  • Previous prostate surgery, including transurethral resection of the prostate or open prostatectomy.

Other illness

  • History of prostate cancer or suspicious findings on prostate biopsy.
  • Active urinary tract infection.
  • Chronic urinary retention associated with neurogenic bladder. Hypersensitivity to norepinephrine or methylene blue.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Benha University Hospital
Coordinator of this site? Confirm its status
BanhāEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.