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NOT YET RECRUITING
NCT07904702
NA

Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Benign prostatic hyperplasia (BPH) is a common non-cancerous enlargement of the prostate gland in aging men that causes bothersome lower urinary tract symptoms (LUTS), including frequent urination, weak urinary stream, and difficulty emptying the bladder. Prostatic artery embolization (PAE) is a minimally invasive, image-guided catheter procedure that blocks blood flow to the prostate, leading to gland shrinkage and symptom relief. While traditional PAE utilizes particulate agents, N-butyl cyanoacrylate (NBCA / Histoacryl) glue is a liquid embolic material that may offer advantages such as shorter procedural duration, lower radiation exposure, and permanent vascular occlusion. The purpose of this prospective, single-arm study is to evaluate the feasibility, safety, and clinical efficacy of using Histoacryl glue mixed with Lipiodol (1:8 dilution ratio) during prostatic artery embolization in men with symptomatic BPH who have failed or cannot tolerate medical therapy. All enrolled participants will undergo PAE with the Histoacryl glue mixture. Participants will be monitored for procedural safety and followed up at 1 month and 3 months post-procedure. Follow-up assessments include urinary symptom improvement using the International Prostate Symptom Score (IPSS), quality of life (QoL) ratings, post-void residual urine volume, prostate-specific antigen (PSA) levels, pelvic imaging to measure prostate volume reduction, and monitoring for any procedure-related complications.

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-11

Completion Date

2027-12

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

PROCEDURE

Prostatic Artery Embolization with N-butyl Cyanoacrylate

Participants undergo transcatheter prostatic artery embolization (PAE) performed in an angiography suite. Vascular access is secured using a 5 Fr vascular sheath and diagnostic catheter (5 Fr cobra), followed by superselective catheterization of the prostatic arteries using a 2.0-2.7 Fr microcatheter with a hydrophilic microwire. After flushing the microcatheter with a non-ionic 5% glucose solution to prevent premature polymerization, embolization is performed by injecting an N-butyl cyanoacrylate (NBCA / Histoacryl) and Lipiodol mixture at an optimized 1:8 dilution ratio under real-time fluoroscopic guidance until complete vascular stasis is achieved.