An interventional study of Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection and Conventional Bipolar Prostatic Enucleation-Enucleoresection in Prostatic Hyperplasia and Lower Urinary Tract Symptoms, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 100 is close to the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Hydrodissection-Assisted 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.
Procedure: Conventional 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.
Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.
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: Intraoperatively
Operative Time
Operative time will be measured in minutes from insertion of the resectoscope until completion of urethral catheter placement.
Time frame: Intraoperatively
Enucleated Prostatic Tissue Weight
The removed prostatic adenomatous tissue will be weighed in grams.
Time frame: Immediately after tissue retrieval, intraoperatively
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 days
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 days
Change in Maximum Urinary Flow Rate
Maximum urinary flow rate will be measured by uroflowmetry in mL/second. Values obtained after surgery will be compared with the preoperative baseline value.
Time frame: At baseline and at 1, 3, and 6 months after surgery
Change in Post-Void Residual Urine Volume
Post-void residual urine volume will be measured by ultrasonography in milliliters. Values obtained after surgery will be compared with the preoperative baseline value.
Time frame: At baseline and at 1, 3, and 6 months after surgery
Change in International Prostate Symptom Score
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.
Time frame: At baseline and at 1, 3, and 6 months after surgery
Incidence of Postoperative Complications
The proportion of participants experiencing postoperative complications will be recorded.
Time frame: At 1, 3, and 6 months after surgery
Incidence of Intraoperative Complications
The proportion of participants experiencing intraoperative complications will be recorded.
Time frame: Intraoperatively
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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