Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes

NCT07733167 | Recruiting Phase 3

• 1 other identifier: ms 20-3-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes

Conditions

Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss , need of blood transfusion

  assessment of Blood Loss (Irrigation Fluid Hb Concentration): Bladder irrigation will be maintained for 24 hours post operatively, with fluid collections made at three intervals: Immediately postsurgery (V1), 6 hours postoperation (V2), and 24 hours postoperation (V3). The total volume collected will be measured, and 5000U of heparin will be added to each irrigation fluid container to prevent coagulation. After thorough mixing, 5-mL samples will be extracted and analyzed using cyanide met hemoglobin spectrophotometry at 540 nm to determine the Hb concentration. Blood loss will be estimated using specific formulas: (1) Hb concentration in irrigation fluid (g/L) = absorbance of fluid × 367.7; (2) Bleeding volume (mL) = (Hb concentration in irrigation fluid (g/L) × rinse volume (mL)) / preoperative Hb concentration(g/L).

  24h post operative

Secondary Outcomes (1)

• Prostate volume , post voiding residual urine

  3 months

Study Arms (2)

Epinephrine injection

ACTIVE COMPARATOR

Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate

Device: TURP; Drug: Epinephrine

saline injection

PLACEBO COMPARATOR

Device: TURP

Interventions

TURP DEVICE

Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate

Epinephrine injection; saline injection

Epinephrine DRUG

Intra-Prostatic epinephrine injection in Bipolar Transurethral resection of large prostate

Epinephrine injection

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for Prostate Surgery or Procedure - Patients undergoing transurethral resection of the prostate (TURP)
• Prostate from 80 to 100 gm
• Failed medical therapy

You may not qualify if:

• Uncontrolled Hypertension - Patients with significantly high blood pressure despite medication therapy.
• Unstable angina, recent myocardial infarction, arrhythmias, or severe heart failure.
• Significant Coagulopathy - Patients with bleeding disorders or on anticoagulants where excessive vasoconstriction may lead to tissue necrosis or inadequate perfusion
• Hyperthyroidism, Pheochromocytoma or Endocrine Disorders - Patients with catecholamine-secreting tumors or other conditions that can lead to excessive sympathetic stimulation.
• Treatment in the last 3 months with 5-alpha reductase inhibitors.
• Genitourinary cancer, urinary tract lithiasis, and urological surgery within the last 3 months

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ahmed Abdelraouf Saad

Banhā, Qalyubia Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Transurethral Resection of Prostate; Epinephrine

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: urology resident , urology department, Principal Investigator , benha university

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 29, 2026
• Study Start: March 20, 2025
• Primary Completion: March 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

EG (1)