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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection
Procedure/SurgeryTransrectal 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/SurgeryParticipants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Hydrodissection-Assisted Bipolar Prostatic Enucleation-EnucleoresectionExperimental treatment 1 intervention
Group B: Conventional Bipolar Prostatic Enucleation-EnucleoresectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative Blood Loss
The estimated volume of blood lost during the operative procedure will be recorded in milliliters and compared between the hydrodissection-assisted and conventional groups.
Time frame
IntraoperativelySecondary outcomes
1
Operative Time
Operative time will be measured in minutes from insertion of the resectoscope until completion of urethral catheter placement.
Time frame
Intraoperatively2
Enucleated Prostatic Tissue Weight
The removed prostatic adenomatous tissue will be weighed in grams.
Time frame
Immediately after tissue retrieval, intraoperatively3
Length of Hospital Stay
The duration of hospitalization will be measured in hours from completion of surgery until hospital discharge.
Time frame
From completion of surgery until hospital discharge, assessed up to 7 days4
Urethral Catheterization Duration
The duration of postoperative urethral catheterization will be measured in hours from catheter placement at the end of surgery until catheter removal.
Time frame
From completion of surgery until catheter removal, assessed up to 7 daysSponsors and contacts
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Source ClinicalTrials.gov
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