Benign Prostatic HyperplasiaPhase 2EVEREST-INCT03423979
Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
A Phase 2 study testing Optilume™ BPH Prostatic DCB Dilation Catheter and Paclitaxel in people with Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, run by Urotronic Inc. at 5 sites in 2 countries.
Trial summary
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
- What is being tested?
- Optilume™ BPH Prostatic DCB Dilation Catheter and Paclitaxel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Dec 2017to 25 May 2024
- Phase
- Phase 2
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
- LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
- Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
- Post-void residual (PVR) ≤ 250 ml
- Prostate volume 20 - 80 gm as determined by TRUS
- Prostatic urethra length is 35 - 55 mm as determined by TRUS
- Able to complete the study protocol in the opinion of the investigator
Who cannot join
- Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
- Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
- Presence of a penile implant or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
- Confirmed or suspected malignancy of prostate or bladder
Show all 35Show fewer
- Active or history of epididymitis within the past 3 months
- Previous pelvic irradiation or radical pelvic surgery
- Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
- Visible hematuria with subject urine sample without known contributing factor
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)
- Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
- Use of 5-alpha reductase inhibitor within 6 months prior to treatment
- Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
- Post-void residual volume > 250 ml or catheter dependent bladder drainage
- Overactive bladder (OAB) or urge incontinence
- Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
- Current bladder stones or prostatic calculi
- Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure
- History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years
- History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion
- Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
- Expected life expectancy < one year
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
- Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study
- In the opinion of the investigator, it is not in the subject's best interest to participate in the study
- Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel)
- Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study
- Device that corresponds with the subject's prostate size per the IFU is not available
- Intravesical prostatic protrusion (IPP) > 1 cm
- Current uncontrolled diabetes (hemoglobin A1c > 7%)
- Unable or unwilling to provide all the protocol-required semen samples
- Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Dominican Republic3 sites
Centro Medico Dr. Canela, SRL
La Romana
Union Medica Hospital
Santiago de los Caballeros, Santiago Province
Urolaser SRL
Santo Domingo Oeste, Santo Domingo Province
Panama2 sites
Consultorios Royal Center
Panama City, Urbanización Marbella Ciudad de Panamá
Centro Especializado San Fernando
Panama City
About this study
Official title: Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.
Read the detailed description
A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first.
Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.
Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.
- Being tested
- Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optilume™ BPH Prostatic DCB Dilation CatheterDevice
Also called BPH Prostatic DCB
BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).
PaclitaxelDrug
Also called drug coated balloon
paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
| Study group | Role | What they receive |
|---|---|---|
| Optilume™ BPH Prostatic DCB Dilation Catheter | Experimental | Optilume™ BPH Prostatic DCB treatment procedure Receives: Device: Optilume™ BPH Prostatic DCB Dilation Catheter; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Responder at 3 Months
The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
Measured: 90 days
Major Device/Procedure Related Complications
The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting >14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start19 Dec 2017
- Primary completion4 Jun 2019
- Study completion25 May 2024
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jill Moland, Study director, Urotronic Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423979
- Sponsor's protocol ID
- PR1051
- Acronym
- EVEREST-I
- Status last verified
- Nov 2025
- First submitted
- 30 Jan 2018
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Pichardo M, Rijo E, Espino G, Lay RR, Estrella R, Gonzalez C, Fernandez M, Soriano D, Peralta IM, Kaplan SA. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol. 2023 Aug;41(8):2209-2215. doi: 10.1007/s00345-023-04473-1. Epub 2023 Jun 24.
PubMed 37354260
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03423979
- Acronym / sponsor ID
- EVEREST-I / PR1051
- Keywords
- BPH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.
Detailed description
A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first.
Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.
Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
| Arm | Type | Receives |
|---|---|---|
| Optilume™ BPH Prostatic DCB Dilation Catheter | Experimental | Device: Optilume™ BPH Prostatic DCB Dilation Catheter, Drug: PaclitaxelOptilume™ BPH Prostatic DCB treatment procedure |
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)
- Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
- LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
- Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
- Post-void residual (PVR) ≤ 250 ml
- Prostate volume 20 - 80 gm as determined by TRUS
Key exclusion criteria (35 listed)
- Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
- Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
- Presence of a penile implant or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
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 |
|---|---|---|
| Optilume™ BPH Prostatic DCB Dilation CatheterAlso: BPH Prostatic DCBBPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU). | Device | Optilume™ BPH Prostatic DCB Dilation Catheter |
| PaclitaxelAlso: drug coated balloonpaclitaxel will release to adjacent tissue after the balloon inflated in the urethra | Drug | Optilume™ BPH Prostatic DCB Dilation Catheter |
Primary outcome
Therapeutic Responder at 3 Months
Time frame: 90 days
The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
Major Device/Procedure Related Complications
Time frame: 90 days
The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting >14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37354260Pichardo M, Rijo E, Espino G, Lay RR, Estrella R, Gonzalez C, Fernandez M, Soriano D, Peralta IM, Kaplan SA. Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. World J Urol. 2023 Aug;41(8):2209-2215. doi: 10.1007/s00345-023-04473-1. Epub 2023 Jun 24.
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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.
Jill Moland study director
Urotronic Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Optilume™ BPH Prostatic DCB Dilation Catheter and Paclitaxel in people with Benign Prostatic Hyperplasia and Benign Prostatic Hypertrophy, run by Urotronic Inc. at 5 sites in 2 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 7 inclusion and 35 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Dominican Republic, Panama. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 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?
Therapeutic Responder at 3 Months (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT03423979, 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 26 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.