Benign Prostatic HyperplasiaNCT07904702
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
A study testing Prostatic Artery Embolization with N-butyl Cyanoacrylate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Prostatic Artery Embolization with N-butyl Cyanoacrylate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 50 years and older.
- Moderate or severe lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), defined by an International Prostate Symptom Score (IPSS) of 8 or greater (moderate LUTS: IPSS 8-19; severe LUTS: IPSS 20-35).
- Documented failure or intolerance of standard medical therapy for BPH.
- Ability and willingness to provide voluntary written informed consent.
Who cannot join
- Confirmed or suspected prostate carcinoma.
- Active urinary tract infection (UTI).
- Renal impairment.
- Known severe allergy or hypersensitivity to iodinated contrast media.
- History of prior prostatic artery embolization (PAE).
- Refusal to participate in the study or inability to provide informed consent.
About this study
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.
- Being tested
- Prostatic Artery Embolization with N-butyl Cyanoacrylate
- Keywords
- Prostatic Artery Embolization, PAE, Histoacryl, N-butyl cyanoacrylate, Lipiodol, Interventional Radiology
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic Artery Embolization with N-butyl CyanoacrylateProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Artery Embolization with Histoacryl Glue | Experimental | 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. Receives: Procedure: Prostatic Artery Embolization with N-butyl Cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Ahmed Mohamed Eltaher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904702
- Sponsor's protocol ID
- PAE Using Histoacryl for BPH
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
- ClinicalTrials.gov ID
- NCT07904702
- Acronym / sponsor ID
- PAE Using Histoacryl for BPH
- Keywords
- Prostatic Artery Embolization, PAE, Histoacryl, N-butyl cyanoacrylate, Lipiodol, Interventional Radiology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostatic Artery Embolization with Histoacryl Glue | Experimental | Procedure: Prostatic Artery Embolization with N-butyl CyanoacrylateParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged 50 years and older.
- Moderate or severe lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), defined by an International Prostate Symptom Score (IPSS) of 8 or greater (moderate LUTS: IPSS 8-19; severe LUTS: IPSS 20-35).
- Documented failure or intolerance of standard medical therapy for BPH.
- Ability and willingness to provide voluntary written informed consent.
Key exclusion criteria (6 listed)
- Confirmed or suspected prostate carcinoma.
- Active urinary tract infection (UTI).
- Renal impairment.
- Known severe allergy or hypersensitivity to iodinated contrast media.
- History of prior prostatic artery embolization (PAE).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostatic Artery Embolization with N-butyl CyanoacrylateParticipants 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. | Procedure or surgery | Prostatic Artery Embolization with Histoacryl Glue |
Primary outcome
Clinical Success Rate
Time frame: 3 months post-procedure
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prostatic Artery Embolization with N-butyl Cyanoacrylate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.