Benign Prostatic HyperplasiaPROstateNCT03527589
Embosphere® PROstate Post Market Study
An observational study of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Merit Medical Systems, Inc. at 15 sites in 4 countries.
Trial summary
Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Prostate artery embolization
- Type of treatment
- Medical device
- How many people
- 499 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 16 Aug 2018to 22 Jan 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with lower urinary tract sypmtoms (LUTS) due to benign prostatic hyperplasia (BPH)
Who may be able to join
- Patient has signed informed consent
- Patient age is 18 years or older at time of informed consent
- Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
Who cannot join
- Patient is unable or unwilling to provide follow-up information
- Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
- Any other reason the investigator deems cause for exclusion
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States8 sites
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
VA Long Beach Healthcare Systems
Long Beach, California, 90822
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
University of California Los Angeles
Los Angeles, California, 90095
University of Miami- Miller School of Medicine
Miami, Florida, 33136
UC Irvine Health
Orange, California, 92868
Providence Sacred Heart
Spokane, Washington, 99204
St. Louis University Hospital
St Louis, Missouri, 63110
United Kingdom4 sites
Royal Bournemouth and Christchurch Hospital
Bournemouth, BH7 7DW
Frimley Park Hospital
Camberley, Surrey, GU16 7UJ
Churchill Hospital
Headington, Oxford, OX3 7LE
Royal Berkshire Hospital
Reading
Italy2 sites
Azienda Ospedaliera S. Croce e Carle Cuneo
Cuneo, 12100
Ospedale Niguarda Ca' Granda
Milan, 20162
About this study
Official title: A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres
Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.
Read the detailed description
This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months and 24 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.
- Being tested
- Prostate artery embolization
- Keywords
- Prostatic Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), Embolization, Embolic, Embosphere Microsphere
- 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
Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
| Study group | Role | What they receive |
|---|---|---|
| Treated with Embosphere Microspheres | Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion). Receives: Device: Prostate artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).
The two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores on a scale' is the unite of measure
Measured: 12 Months
Secondary outcomes (7)
International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.
The time points used in the calculation were baseline, 3 months and 24 months. The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints). The same calculation was also done at 24 months. From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Measured: 3, 24 Months
Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.
The time points used in the calculation were baseline, 3 months and 24 months. The calculation was done using the 3 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 3 month timepoints). The same calculation was also done at 24 months. From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Measured: 3, 24 Months
Device or Procedure Related Adverse Events Post Procedure.
The measure used to assess "device or procedure related adverse events post procedure" at three different time points (3, 12, 24 months) are frequencies and percentages. For each visit (or reporting time point), the event rate will be calculated as the number of subjects with certain event terms over the number of evaluable subjects. The evaluable subjects at each reporting time point include all subjects who are enrolled and
- had an event within (on or before) the reporting cutoff days, or
- had a follow-up at or after the lower limit of the reporting window, or
- the withdrawal consent date/recorded lost-to-follow-up date at or after the lower limit of the reporting window.
Measured: 3, 12, 24 Months
Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
Measured: 3, 12, 24 Months
Technical Success Defined as Successful Embolization of the Treated Prostate Gland.
Measured: Day of PAE Procedure
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
Measured: 3, 12, 24 Months
Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM).
The calculation was done using the 12 months mean Sexual Health Inventory for Men (SHIM) score minus the baseline mean SHIM score for paired data (e.g., available data on both baseline and 12 month timepoints). From the SHIM questionnaire, the total scores was used and range from 1 to 25 with higher scores representing better outcomes (no signs of erectile dysfunction) and lower scores representing worse outcomes (severe erectile dysfunction). There are a total of 5 questions on the scale and the scores from each question are summed to get a total score. A positive change score means improvement of outcomes. 'Scores' on a scale is the unite of measure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start16 Aug 2018
- Primary completion21 Jan 2020
- Study completion22 Jan 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 HyperplasiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 499 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527589
- Sponsor's protocol ID
- PAE-P4-17-01
- Acronym
- PROstate
- Status last verified
- Dec 2023
- First submitted
- 24 Apr 2018
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sapoval MR, Bhatia S, Dean C, Rampoldi A, Carnevale FC, Bent C, Tapping CR, Bongiovanni S, Taylor J, Brower JS, Rush M, McWilliams JP, Little MW; PROstate Study Investigators. Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study. Cardiovasc Intervent Radiol. 2024 Nov;47(11):1515-1524. doi: 10.1007/s00270-024-03802-0. Epub 2024 Sep 4.
PubMed 39230672
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Post Market Study of Patients With Symptomatic Benign Prostatic Hyperplasia Treated by Prostatic Artery Embolization With Embosphere® Microspheres
- ClinicalTrials.gov ID
- NCT03527589
- Acronym / sponsor ID
- PROstate / PAE-P4-17-01
- Keywords
- Prostatic Artery Embolization (PAE), Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms (LUTS), Embolization, Embolic, Embosphere Microsphere
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 22 Jan 2022 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostatic artery embolization with Embosphere Microspheres is a relatively new procedure. The goal of this post market study is to evaluate long-term safety and effectiveness in a 'real world' setting.
Detailed description
This is a prospective, open label post market study to evaluate the long-term safety and effectiveness of prostatic artery embolization (PAE) using Embosphere Microspheres. Up to 500 patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be enrolled in this single arm post market study. All patients at sites who meet eligibility criteria will be offered participation. Long term effectiveness of PAE on LUTS will be evaluated by International Prostate Symptom Score (IPSS) at baseline, 3 months, 12 months and 24 months. Safety will be assessed by evaluating device or procedure-related adverse events at the same time points, plus at 4 weeks following embolization. Erectile function will be assessed at baseline and 12 months by Sexual Health Inventory for Men (SHIM) score. Additional treatments for refractory or recurrent LUTS due to BPH post prostatic artery embolization will also be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with Embosphere Microspheres | – | Device: Prostate artery embolizationPatients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres (size of embolic determined at Investigator discretion). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with lower urinary tract sypmtoms (LUTS) due to benign prostatic hyperplasia (BPH)
Key inclusion criteria (3 listed)
- Patient has signed informed consent
- Patient age is 18 years or older at time of informed consent
- Patient will undergo prostatic artery embolization with Embosphere Microspheres for the treatment of symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
Key exclusion criteria (3 listed)
- Patient is unable or unwilling to provide follow-up information
- Patient is undergoing prostatic artery embolization for reasons that do not include symptomatic benign prostatic hyperplasia with lower urinary tract symptoms
- Any other reason the investigator deems cause for exclusion
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 embolizationPatients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization. | Device | Treated with Embosphere Microspheres |
Primary outcome
Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS).
Time frame: 12 Months
The two time points used in the calculation were baseline and 12 months. The calculation was done using the 12 months mean International Prostate Symptom Score (IPSS) minus the baseline mean IPSS for paired data (e.g., available data on both baseline and 12 month timepoints). From the IPSS questionnaire, the total score was used and range from 0 to 35 with lower scores representing better outcomes and higher scores representing worse outcomes. There are a total of 7 questions on the scale and the scores from each question are summed to get a total score. A negative change score means improvement of outcomes. 'Scores on a scale' is the unite of measure
7 secondary outcomes
International Prostate Symptom Score (IPSS) After Discontinuation of Indwelling Bladder Catheter (IBC) Post PAE.
Time frame: 3, 24 Months
Quality of Life Due to Urinary Symptoms After Discontinuation of Indwelling Bladder Catheter (IBC) Post Prostate Artery Embolization (PAE) Using the International Prostate Symptom Score (IPSS) Quality of Life Assessment Index.
Time frame: 3, 24 Months
Device or Procedure Related Adverse Events Post Procedure.
Time frame: 3, 12, 24 Months
Frequency of Indwelling Bladder Catheter (IBC) Removal Post PAE.
Time frame: 3, 12, 24 Months
Technical Success Defined as Successful Embolization of the Treated Prostate Gland.
Time frame: Day of PAE Procedure
Additional Treatments for Refractory or Recurrent Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Post Prostatic Artery Embolization (PAE).
Time frame: 3, 12, 24 Months
Change From Baseline in Erectile Function Post Prostatic Artery Embolization (PAE) Using the Sexual Health Inventory for Men (SHIM).
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39230672Sapoval MR, Bhatia S, Dean C, Rampoldi A, Carnevale FC, Bent C, Tapping CR, Bongiovanni S, Taylor J, Brower JS, Rush M, McWilliams JP, Little MW; PROstate Study Investigators. Two-Year Outcomes of Prostatic Artery Embolization for Symptomatic Benign Prostatic Hyperplasia: An International, Multicenter, Prospective Study. Cardiovasc Intervent Radiol. 2024 Nov;47(11):1515-1524. doi: 10.1007/s00270-024-03802-0. Epub 2024 Sep 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Merit Medical Systems, Inc. at 15 sites in 4 countries.
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 3 inclusion and 3 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, United Kingdom, Italy, France. 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 18 Dec 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?
Long-term Effectiveness of Prostatic Artery Embolization (PAE) With Embosphere Microspheres as Assessed by the International Prostate Symptom Score (IPSS). (time frame: 12 Months). 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 NCT03527589, 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 18 Dec 2023.