Benign Prostatic HyperplasiaNCT05155891
Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate
A study testing Embosphere Microspheres and HoLEP Procedure in people with Benign Prostatic Hyperplasia, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Embosphere Microspheres and HoLEP Procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 1 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
- Patient is age 50 or older.
- Patient has signed informed consent and agrees to attend all follow-up study visits.
- Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.
- Patient has a baseline IPSS Score > 13 at baseline.
- Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).
- Patient has BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated, or refused.
- Patient must be a candidate for HoLEP or PAE.
Who cannot join
- Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)
- Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).
- Patients with indwelling urinary catheters or those performing self-catheterization.
- Biopsy proven prostate or bladder cancer.
- Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy.
- Patients with neurogenic bladder disorder.
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- Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition.
- Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).
- Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
- Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months.
- Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.
- Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm
- History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
- History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.
- History of hypersensitivity to gelatin products will be excluded from PAE arm.
- Subject has a life expectancy of less than 2 yrs.
- Post void residual more than 500 ml at baseline.
- Participation in any other BPH trials during the time of study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-Randomized, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia in Prostate Glands Larger Than 80 Grams
The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Embosphere Microspheres, HoLEP Procedure
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embosphere MicrospheresDevice
The SOC PAE procedure will be performed by attempting to embolize prostatic arteries of both sides in a single session with 300-500 um Embosphere Microspheres. The microspheres will be mixed with a contrast agent and will be delivered to the arteries supplying the prostate via a microcatheter.
HoLEP ProcedureProcedure or surgery
The SOC PAE procedure will be performed with the SOC HoLEP as per standard institutional guidelines. The HoLEP procedure involves passing a telescope through the urethra and removing the central part of the prostate gland using a laser.
| Study group | Role | What they receive |
|---|---|---|
| Embosphere Microspheres group | Experimental | Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery. Receives: Device: Embosphere Microspheres |
| HoLEP Group | Active comparator | Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP). Receives: Procedure: HoLEP Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BPH symptoms as measured by the IPSS
The International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
Measured: Baseline, 3 months
Secondary outcomes (13)
Duration of hospitalization after the procedure
The duration of hospitalization associated with each procedure will be calculated in hours.
Measured: up to 48 hours
Duration of urinary catheterization after the procedure
The duration of urinary catheterization associated with each procedure will be calculated in hours.
Measured: up to 48 hours
Change in BPH symptoms as measured by IPSS
International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
Measured: Baseline, 12 months
Change in peak urine flow rate
The peak urine flow rate (Qmax) will be measured via uroflowmetry
Measured: Baseline, 12 months
Change in post-void residual urinary volume (PVR)
PVR will be measured using an ultrasound bladder scanner
Measured: Baseline, 12 months
Change in erectile function as measured by the IIEF
The International Index of Erectile Function (IIEF) has a total score ranging from 0-25 with higher score indicating better erectile function
Measured: Baseline, 12 Months
Change in retrograde ejaculation as measured by the Ejaculatory questionnaire
The Ejaculatory Questionnaire has a total score ranging from 0-20 with the higher score indicating better outcomes
Measured: Baseline, 12 Months
Change in incontinence as measured by the ICIQ - UI SF
The International Consultation on Incontinence Questionnaire (ICIQ) -Urinary Incontinence (UI) Short Form (SF) is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Measured: Baseline, 12 Months
Change in mean prostate volume
As measured by Magnetic Resonance Imaging (MRI) and transrectal ultrasound (TRUS)
Measured: Baseline, 12 months
Change in prostate specific antigen (PSA) levels
As measured by serum blood samples
Measured: Baseline, 12 Months
Incidence of adverse events
As evaluated by treating physician
Measured: Up to 12 Months
Incidence of procedure-related adverse events
As evaluated by treating physician
Measured: Up to 12 Months
Change in medication use related to BPH-LUTS
Change in BPH lower urinary tract symptoms (LUTS) medication use (including alpha blockers, 5-alpha reductase inhibitors and phosphodiesterase type 5 (PDE5) inhibitors) will be reported
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start17 Jun 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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 University of MiamiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemendra Shah, University of Miami
- Investigators
- Hemendra Shah, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155891
- Sponsor's protocol ID
- 20210029
- Status last verified
- Apr 2026
- First submitted
- 30 Nov 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Controlled Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia in Prostate Glands Larger Than 80 Grams
- ClinicalTrials.gov ID
- NCT05155891
- Acronym / sponsor ID
- 20210029
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Dec 2021 (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.
The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embosphere Microspheres group | Experimental | Device: Embosphere MicrospheresParticipants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery. |
| HoLEP Group | Active comparator | Procedure: HoLEP ProcedureParticipants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP). |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is age 50 or older.
- Patient has signed informed consent and agrees to attend all follow-up study visits.
- Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.
- Patient has a baseline IPSS Score > 13 at baseline.
- Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).
Key exclusion criteria (18 listed)
- Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)
- Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).
- Patients with indwelling urinary catheters or those performing self-catheterization.
- Biopsy proven prostate or bladder cancer.
- Patients with neurogenic bladder disorder.
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 |
|---|---|---|
| Embosphere MicrospheresThe SOC PAE procedure will be performed by attempting to embolize prostatic arteries of both sides in a single session with 300-500 um Embosphere Microspheres. The microspheres will be mixed with a contrast agent and will be delivered to the arteries supplying the prostate via a microcatheter. | Device | Embosphere Microspheres group |
| HoLEP ProcedureThe SOC PAE procedure will be performed with the SOC HoLEP as per standard institutional guidelines. The HoLEP procedure involves passing a telescope through the urethra and removing the central part of the prostate gland using a laser. | Procedure or surgery | HoLEP Group |
Primary outcome
Change in BPH symptoms as measured by the IPSS
Time frame: Baseline, 3 months
The International Prostate Symptom Score (IPSS) has a total score ranging from 0-35 with the higher score indicating more severe symptoms
13 secondary outcomes
Duration of hospitalization after the procedure
Time frame: up to 48 hours
Duration of urinary catheterization after the procedure
Time frame: up to 48 hours
Change in BPH symptoms as measured by IPSS
Time frame: Baseline, 12 months
Change in peak urine flow rate
Time frame: Baseline, 12 months
Change in post-void residual urinary volume (PVR)
Time frame: Baseline, 12 months
Change in erectile function as measured by the IIEF
Time frame: Baseline, 12 Months
Change in retrograde ejaculation as measured by the Ejaculatory questionnaire
Time frame: Baseline, 12 Months
Change in incontinence as measured by the ICIQ - UI SF
Time frame: Baseline, 12 Months
Change in mean prostate volume
Time frame: Baseline, 12 months
Change in prostate specific antigen (PSA) levels
Time frame: Baseline, 12 Months
Incidence of adverse events
Time frame: Up to 12 Months
Incidence of procedure-related adverse events
Time frame: Up to 12 Months
Change in medication use related to BPH-LUTS
Time frame: Baseline, 12 Months
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 20 Apr 2026.
- 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.
Hemendra Shah, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embosphere Microspheres and HoLEP Procedure in people with Benign Prostatic Hyperplasia, run by University of Miami 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 7 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. 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?
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?
Change in BPH symptoms as measured by the IPSS (time frame: Baseline, 3 months). 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 20 Apr 2026.