An interventional study of Prostatic Artery Embolization with N-butyl Cyanoacrylate in Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 30 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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 undergo transcatheter prostatic artery embolization (PAE) using N-butyl cyanoacrylate (NBCA / Histoacryl) liquid embolic glue mixed with Lipiodol at a 1:8 dilution ratio under fluoroscopic guidance. Non-ionic glucose solution is utilized for microcatheter flushing prior to glue injection to prevent premature polymerization. Clinical, laboratory, and imaging follow-up assessments are conducted at 1 and 3 months post-procedure.
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.
Clinical Success Rate
Percentage of participants achieving clinical success, defined as a reduction in the International Prostate Symptom Score (IPSS) of at least 25% (or a minimum reduction of 3 points) from baseline without requiring additional surgical intervention or re-catheterization. The IPSS is a validated 7-item questionnaire assessing urinary symptoms, scored from 0 to 35, where higher scores represent more severe symptoms (0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic).
Time frame: 3 months post-procedure
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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