Hydrodissection-Assisted Bipolar Prostatic Enucleation Versus Conventional Bipolar Enucleation

NCT07749794 | Not Yet Recruiting

• 1 other identifier: RC.8.1.2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Bipolar prostatic enucleation; Hydrodissection; Subcapsular prostatic injection; Norepinephrine; Methylene blue

Outcome Measures

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.

  Intraoperatively

Secondary Outcomes (9)

• 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

Study Arms (2)

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection

EXPERIMENTAL

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

Conventional Bipolar Prostatic Enucleation-Enucleoresection

ACTIVE COMPARATOR

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

Interventions

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection PROCEDURE

Transrectal ultrasound-guided subcapsular injection will be used to create a hydrodissection plane between the prostatic adenoma and capsule before bipolar enucleation-enucleoresection.

Hydrodissection-Assisted Bipolar Prostatic Enucleation-Enucleoresection

Conventional Bipolar Prostatic Enucleation-Enucleoresection PROCEDURE

Participants will undergo conventional bipolar prostatic enucleation-enucleoresection without subcapsular injection or hydrodissection.

Conventional Bipolar Prostatic Enucleation-Enucleoresection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Saad A Salama, MD

CONTACT

01063006039; saad.ali@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

EG (1)