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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Benha University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Intraoperative Blood Loss
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection
Participants will undergo transrectal ultrasound-guided subcapsular injection of a diluted norepinephrine-methylene blue mixture to produce hydrodissection between the prostatic adenoma and surgical capsule, followed by bipolar prostatic enucleation-enucleoresection. Standard postoperative bladder irrigation, catheter management, and follow-up will be provided.
Intervention: Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection (Procedure)
Conventional Bipolar Prostatic Enucleation-Enucleoresection
Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection. Standard postoperative bladder irrigation, catheter management, and follow-up will be provided.
Intervention: Conventional Bipolar Prostatic Enucleation-Enucleoresection (Procedure)
Outcomes
Primary Outcomes
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
- Operative Time(Intraoperatively)
- Enucleated Prostatic Tissue Weight(Immediately after tissue retrieval, intraoperatively)
- Length of Hospital Stay(From completion of surgery until hospital discharge, assessed up to 7 days)
- Urethral Catheterization Duration(From completion of surgery until catheter removal, assessed up to 7 days)
- Change in Maximum Urinary Flow Rate(At baseline and at 1, 3, and 6 months after surgery)
- Change in Post-Void Residual Urine Volume(At baseline and at 1, 3, and 6 months after surgery)
- Change in International Prostate Symptom Score(At baseline and at 1, 3, and 6 months after surgery)
- Incidence of Postoperative Complications(At 1, 3, and 6 months after surgery)
- Incidence of Intraoperative Complications(Intraoperatively)
Investigators
Saad ali saad salama
Lecturer of Urology
Benha University