Benign Prostatic Hyperplasia (BPH)NCT03052049

Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

A study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia (BPH), run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH). Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia (BPH)
What is being tested?: Prostate Artery Embolization
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2017to 26 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed.
Ability to understand and the willingness to sign a written informed consent.
Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months.
Men ≥ 45 years of age
IPSS symptom score ≥ 18 and IPSS bother score ≥ 3
Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a documented negative biopsy within previous 12 months.
For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months.

Who cannot join

History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
On alpha-blockers within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit and/or part of a Trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR).
On 5-alpha reductase inhibitors within the past 6 months. Unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit
On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks. Unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit.
On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit
Daily use of a pad or device for incontinence required.

Show all 28Show fewer

Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible)
renal insufficiency (i.e. creatinine > 1.8)
Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
Neurogenic bladder, Hypotonic Bladder
Prior treatment for urinary incontinence
Penile prosthesis.
Artificial urinary sphincter.
Documented bacterial prostatitis within the past year.
Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization.
History of chronic prostatitis within the last 1 year
Known bleeding disorders (e.g. VWD)
Prior prostate procedures (e.g. Transurethral Microwave Therapy (TUMT), Transurethral Needle Ablation of the Prostate (TUNA), Water-induced Thermotherapy (WIT), Transurethral Resection of the Prostate (TURP), Photoselective Vaporization of the Prostate (PVP)
Prior treatment for overactive bladder (e.g. intravesical botox)
Enrolled in another treatment trial for any disease within the past 30 days
Declines or unable to provide informed consent
Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression.
A history of rectal malignancy
Prior surgical prostate intervention
Interest in future fertility
Allergy to iodinated contrast agents not responsive to steroid premedication regimen
Contraindication to conscious sedation

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

Read the detailed description

This pilot study will be a single center, open labeled, non-randomized feasibility study to evaluate the initial safety of PAE for the treatment of symptomatic bladder outlet obstruction. 30 adult male subjects will be enrolled in this study. If eligible patients will undergo the prostate artery embolization procedure in the Interventional Radiology department. An angiogram of the prostate arteries will be done. Small beads called Bead Block microspheres will be injected into the prostate artery to slow blood flow to the prostate in the hope of providing relief with minimal side effects and complications, for lower urinary tract symptoms caused by BPH. After the procedure the patient will be followed at 4 weeks, 12 weeks, 6 months, and 12 months post procedure.

Conditions: Benign Prostatic Hyperplasia (BPH)
Being tested: Prostate Artery Embolization
Keywords: Prostate Artery Embolization
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prostate Artery EmbolizationDevice
Also called The interventional type is a procedure
The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.

Study groups in NCT03052049
Study group	Role	What they receive
Prostate Artery Embolization	Experimental	There is only one arm of this study where patients receive Prostate Artery Embolization Receives: Device: Prostate Artery Embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .
The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure:
Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death.
Measured: 1 year

Secondary outcomes (4)

Change in International Prostate Symptom Score (IPSS)
Questionnaire- IPSS has 7 questions. Answer choices are as follows. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.
It is a validated, reproducible scoring system to assess disease severity and response to therapy.
The IPSS is made up of 7 questions related to voiding symptoms. Scores can range from 0-35 with 0 being the better outcome and 35 the worst outcome.
Question 1-6 0-Not at all
1. Less than 1 time in 5
2. Less than half the time
3. About half the time
4. More than half the time
5. Almost always
Question 7 0-None 1-1 time 2-2 times 3-3 times 4-4 times 5-5 or more times
Measured: Baseline, 1, 3, 6, 12 months post procedure
Change in Quality of Life (QOL) Bother Score
The total score ranges from 0-6 with 0 being the best outcome and 6 being the worst outcome.
Questionnaire- answers choices are as follows:
0- Delighted
1. Pleased
2. Mostly Satisfied
3. Mixed about equality satisfied and dissatisfied
4. Mostly Dissatisfied
5. Unhappy
6. Terrible
Measured: Baseline, 1, 3, 6, 12 months post procedure
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score
The BPH Impact Index is to assess the impact of BPH symptoms on patient health and functioning. It is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities.The BII is an evaluative index useful in measuring the magnitude of change in the impact of BPH-LUTS within a person over time.
Scores range from 0-13 with 0 being the best outcome and 13 being the worst.
Questionnaire- consists of 4 questions; answer choices are as follows Question 1: 0-none, 1-only a little, 2-some, 3-a lot Question 2: 0-none, 1-only a little, 2-some, 3-a lot Question 3: 0-not at all bothersome, 1- bothers me a little, 2-bothers me some, 3-bothers me a lot Question 4: 0-none of the time, 1- a little of the time, 2- some of the time, 3-most of the time, 4-all of the time
Measured: Baseline, 1, 3, 6, 12 months post procedure
Change in Peak Urine Flow (Qmax)
Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements
Measured: Baseline, 1, 3, 6, and 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201726 Sep 2022

First posted14 Feb 2017
Study start6 Sep 2017
Primary completion26 Sep 2022
Study completion26 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
More trials run by Northwestern 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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03052049
Sponsor's protocol ID: STU 00204385
Status last verified: Oct 2023
First submitted: 8 Feb 2017
Last updated: 10 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Knight GM, Varadhan A, Benishay E, Rivera-Rodriguez DM, Jenkins K, Hohlastos E, Salem R, Mouli S. Who should be considered for prostate artery embolization: revisiting the urologic guidelines based on results from over 300 patients with benign prostatic hyperplasia. CVIR Endovasc. 2026 Oct 23;9(1):135. doi: 10.1186/s42155-026-00703-w.
PubMed 42909729

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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All Benign Prostatic Hyperplasia (BPH) trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
ClinicalTrials.gov ID: NCT03052049
Acronym / sponsor ID: STU 00204385
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Prostate Artery Embolization
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: BTG International Inc.
Study start: 6 Sep 2017 (actual)
Primary completion: 26 Sep 2022 (actual)
Study completion: 26 Sep 2022 (actual)
First posted: 14 Feb 2017 (actual)
Results: Posted 12 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Prostate Artery Embolization	Experimental	Device: Prostate Artery EmbolizationThere is only one arm of this study where patients receive Prostate Artery Embolization

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed.
Ability to understand and the willingness to sign a written informed consent.
Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months.
Men ≥ 45 years of age
IPSS symptom score ≥ 18 and IPSS bother score ≥ 3

Key exclusion criteria (28 listed)

History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
On alpha-blockers within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit and/or part of a Trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR).
On 5-alpha reductase inhibitors within the past 6 months. Unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit
On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks. Unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit.
On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or if criteria are met at the 1 year follow up visit

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
Prostate Artery EmbolizationAlso: The interventional type is a procedureThe PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.	Device	Prostate Artery Embolization

Primary outcome

Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .
Time frame: 1 year
The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death.

4 secondary outcomes

Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline, 1, 3, 6, 12 months post procedure
Change in Quality of Life (QOL) Bother Score
Time frame: Baseline, 1, 3, 6, 12 months post procedure
Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score
Time frame: Baseline, 1, 3, 6, 12 months post procedure
Change in Peak Urine Flow (Qmax)
Time frame: Baseline, 1, 3, 6, and 12 months post procedure

Results and safety

Results posted to the registry on 12 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prostate Artery Embolization	28	26

Primary outcome: Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .

Time frame: 1 year. Number. Unit: events

Measure	Prostate Artery Embolization n = 26
Grade 1 AE Mild	6
Grade 2 AE Moderate	10
Grade 3 AE Severe	0
Grade 4 AE life threatening	0
Grade 5 AE Fatal	0

Prostate Artery Embolization: p value: 0.05, p = 0.05, t-test, 2 sided

Population analysed: Events

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were evaluate at each follow up visit at 1 month, 3 months, 6 months and 12 months after the procedure for each subject. Each subject was evaluated over the study duration on average 1 year or 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prostate Artery Embolization	0 of 26 (0%)	10 of 26 (38.5%)	0 of 26

Limitations and caveats (from the sponsor): We were funded for 30 procedures and anticipated 30 patients. 2 of the patients needed a second procedure, resulting in 28 patients enrolled. Also, during COVID, there were patients that did not come for Qmax testing.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42909729Knight GM, Varadhan A, Benishay E, Rivera-Rodriguez DM, Jenkins K, Hohlastos E, Salem R, Mouli S. Who should be considered for prostate artery embolization: revisiting the urologic guidelines based on results from over 300 patients with benign prostatic hyperplasia. CVIR Endovasc. 2026 Oct 23;9(1):135. doi: 10.1186/s42155-026-00703-w.
Individual participant dataSharing planned: No

Related trials for Benign Prostatic Hyperplasia (BPH)

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
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Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
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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. This study is not recruiting at the moment.

Riad Salem, MD principal investigator

Northwestern University

Matthias Hofer, MD study chair

Northwestern University

Bartley Thornburg, MD study chair

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia (BPH), run by Northwestern University at 1 site in United States.

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 8 inclusion and 28 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: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale . (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052049, which also lists 1 linked publication.

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 10 Oct 2023.