Lower Urinary Tract Symptoms, Prostatic Hyperplasia
Conditions
Keywords
Bipolar prostatic enucleation, Hydrodissection, Subcapsular prostatic injection, Norepinephrine, Methylene blue
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.
Interventions
PROCEDUREHydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection
Transrectal ultrasound-guided subcapsular injection will be used to create a hydrodissection plane between the prostatic adenoma and capsule before bipolar enucleation-enucleoresection.
PROCEDUREConventional Bipolar Prostatic Enucleation-Enucleoresection
Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in parallel to undergo either hydrodissection-assisted bipolar prostatic enucleation-enucleoresection with transrectal ultrasound-guided subcapsular injection of diluted norepinephrine-methylene blue mixture or conventional bipolar prostatic enucleation-enucleoresection without hydrodissection or injection.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperatively | Operative time will be measured in minutes from insertion of the resectoscope until completion of urethral catheter placement. |
| Enucleated Prostatic Tissue Weight | Immediately after tissue retrieval, intraoperatively | The removed prostatic adenomatous tissue will be weighed in grams. |
| Length of Hospital Stay | 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. |
| Urethral Catheterization Duration | 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. |
| Change in Maximum Urinary Flow Rate | 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. |
| Change in Post-Void Residual Urine Volume | 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. |
| Change in International Prostate Symptom Score | 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. |
| Incidence of Postoperative Complications | At 1, 3, and 6 months after surgery | The proportion of participants experiencing postoperative complications will be recorded. |
| Incidence of Intraoperative Complications | Intraoperatively | The proportion of participants experiencing intraoperative complications will be recorded. |
Countries
Egypt
Contacts
CONTACTSaad A Salama, MD
Outcome results
None listed