Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBenha University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection
- Conventional Bipolar Prostatic Enucleation-Enucleoresection
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov