Benign Prostatic Hyperplasia (BPH)NCT02026908
Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)
A study testing Prostate Artery Embolization in people with Benign Prostatic Hyperplasia (BPH), run by Northwestern University at 1 site in United States.
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
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2014to 27 Mar 2023
- 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.
- 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 > 13 and IPSS bother score > 2
- Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
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 until stopping criteria is met at the 12 month f/u 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 until stopping criteria is met at the 12 month f/u 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 until stopping criteria is met at the 12 month f/u 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.
- Daily use of a pad or device for incontinence required.
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- Urethral strictures, 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. von willebrand disease (VWD))
- History of urethral strictures/bladder neck closure (BNC)
- 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), photo-vaporization of the prostate (PVP))
- Prior treatment for overactive bladder (e.g. intravesical botox)
- Prostate Specific Antigen (PSA) > 4.0, < 10.0 unless documented negative prostate biopsy within past 2 years and is not thought to harbor prostatic malignancy in the clinical opinion of the primary or co-investigator.
- 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 Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
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 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. 50 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 Embospheres 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, 12 months post procedure and then annually for up to 4 years.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Prostate Artery Embolization
- Keywords
- Prostate Artery Embolization, PAE, Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS
- 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.
Prostate Artery EmbolizationDevice
Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
| 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.
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
The number and the severity of adverse events will be recorded to evaluate safety. Events will be reported by subjects and the severity of events will be graded using the following scale:
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: 5 years
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
- Less than 1 time in 5
- Less than half the time
- About half the time
- More than half the time
- 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, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Change in Quality of Life (QOL) Bother Question
Questionnaire 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
- Pleased
- Mostly Satisfied
- Mixed about equality satisfied and dissatisfied
- Mostly Dissatisfied
- Unhappy
- Terrible
Measured: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Change in Benign Prostatic Hyperplasia (BPH) Impact Index
Questionnaire 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, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
Measure of urine flow rate. Q max = max flow rate. Peak Urine Flow (Qmax) from urodynamic assessments will be summarized comparing baseline to follow up measurements
Measured: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study start1 Jan 2014
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
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 (2)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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riad Salem, Northwestern University
- Investigators
- Riad Salem, MD MBA, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026908
- Sponsor's protocol ID
- STU 00081296
- Other IDs
- IDE G130133
- Status last verified
- Nov 2023
- First submitted
- 19 Dec 2013
- Last updated
- 18 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Salem R, Hairston J, Hohlastos E, Riaz A, Kallini J, Gabr A, Ali R, Jenkins K, Karp J, Desai K, Thornburg B, Casalino D, Miller F, Hofer M, Hamoui N, Mouli S. Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study. Urology. 2018 Oct;120:205-210. doi: 10.1016/j.urology.2018.07.012. Epub 2018 Jul 20.
PubMed 30036614Knight 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. 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
- NCT02026908
- Acronym / sponsor ID
- STU 00081296
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Prostate Artery Embolization, PAE, Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 3 Jan 2014 (estimated)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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. 50 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 Embospheres 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, 12 months post procedure and then annually for up to 4 years.
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 (6 listed)
- Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment.
- 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 > 13 and IPSS bother score > 2
Key exclusion criteria (29 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 until stopping criteria is met at the 12 month f/u 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 until stopping criteria is met at the 12 month f/u 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 until stopping criteria is met at the 12 month f/u 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.
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 EmbolizationProcedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate. | Device | Prostate Artery Embolization |
Primary outcome
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).
Time frame: 5 years
The number and the severity of adverse events will be recorded to evaluate safety. Events will be reported by subjects and the severity of events will be graded using the following scale: 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, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Change in Quality of Life (QOL) Bother Question
Time frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Change in Benign Prostatic Hyperplasia (BPH) Impact Index
Time frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)
Time frame: baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30036614Salem R, Hairston J, Hohlastos E, Riaz A, Kallini J, Gabr A, Ali R, Jenkins K, Karp J, Desai K, Thornburg B, Casalino D, Miller F, Hofer M, Hamoui N, Mouli S. Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study. Urology. 2018 Oct;120:205-210. doi: 10.1016/j.urology.2018.07.012. Epub 2018 Jul 20.
- 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
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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 MBA principal investigator
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 6 inclusion and 29 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 18 Nov 2024. 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 30 Nov 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?
The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH). (time frame: 5 years). 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 NCT02026908, which also lists 2 linked publications.
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 18 Nov 2024.