Benign Prostatic HyperplasiaPINNACLENCT04131907
Optilume™ BPH Catheter System in Men With Symptomatic BPH
A study testing Optilume BPH Catheter System in people with Benign Prostatic Hyperplasia, run by Urotronic Inc. at 21 sites in 2 countries.
Trial summary
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH) Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Optilume BPH Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 5 Feb 2020to May 2027
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject 50-80 years of age who has symptomatic BPH
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
- Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
- Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
- History of inadequate response, contraindication, or refusal of BPH medical therapy
- Able to complete the study protocol in the opinion of the investigator
Who cannot join
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
- Unwilling to abstain or use protected sex for the first 30 days post treatment
- Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
- Presence of an artificial urinary sphincter 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
- Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
Show all 42Show fewer
- Confirmed or suspected malignancy of prostate or bladder
- Active or history of epididymitis within the past 3 months
- Previous pelvic irradiation or pelvic trauma surgery
- Active urinary tract infection (UTI) confirmed by culture
- Bacterial prostatitis within the last 12 months
- Non-bacterial prostatitis within the last 5 years
- Visible or invisible hematuria (> 4 Red Blood Cells (RBCs) per high power field) on 2 separate urine specimens within the last 3 months without a know contributing factor
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- History of urinary incontinence
- Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- Previous rectal surgery, other than hemorrhoidectomy
- Use of antihistamines, anticonvulsants or antispasmodics within 1 week prior to baseline assessment unless there is documented evidence of stable dosing for at least 6 months
- Use of antidepressants with adrenergic effects (i.e. duloxetine, imipramine and amitriptyline), long-acting anticholinergics (LAAC) for chronic obstructive pulmonary disease (COPD), or androgens within 2 weeks prior to baseline assessment unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment
- Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment
- Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment
- Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
- Use of estrogen or drugs producing androgen suppression unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment
- Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment
- Use of warfarin or novel oral anti-coagulants [e.g., apixaban (Eliquis), fondaparinux (Arixtra), rivaroxaban (Xarelto) or edoxaban (Savaysa)], unless the medication is safely discontinued prior to the procedure and is not planned to be restarted for at least 5 days post-procedure
- Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure
- History of hypersensitivity reactions to paclitaxel, on medication that may have negative interaction with paclitaxel, presence of solid tumor with a baseline neutrophil count of <1500 cells/mm3 or AIDS-related Kaposi's sarcoma with baseline neutrophil count of <1000 cells/mm3
- Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
- Current post-void residual volume > 300 ml or catheter dependent bladder drainage
- Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
- Current bladder or prostatic urethral stones
- Biopsy of prostate within 40 days prior to procedure
- History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within five years
- Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%)
- 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
- Life expectancy < 10 years
- Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study
- Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm]
- Device that corresponds with the subject's prostate size is not available
- Currently enrolled in or plan to enroll in another investigational clinical study 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Urology Austin, PLLC
Austin, Texas, 78745
North Austin Urology
Austin, Texas, 78750
Advanced Urology Institute
Daytona Beach, Florida, 32114
Rio Grande Urology
El Paso, Texas, 79912
New Jersey Urology
Englewood, New Jersey, 07631
AccuMed Research Associates
Garden City, New York, 11530
Colorado Clinical Research
Golden, Colorado, 80401
Chesapeake Urology Research Associates
Hanover, Maryland, 21076
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
Sheldon Freedman MD, Ltd
Las Vegas, Nevada, 89144
Arkansas Urology
Little Rock, Arkansas, 72211
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Manhattan Medical Research Practice, PLLC
New York, New York, 10016
Weill Cornell Medical College
New York, New York, 10065
Associated Urologists of NC
Raleigh, North Carolina, 27612
Regional Urology, LLC
Shreveport, Louisiana, 71106
Florida Urology Partners
Tampa, Florida, 33615
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Clear Lake Specialties
Webster, Texas, 77598
Canada2 sites
University of Montreal Hospital Center (CHUM)
Montreal, Quebec, H2X 3E4
University Urology Associates
Toronto, Ontario, M5G 1E2
About this study
Official title: A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
Read the detailed description
This is a prospective, multi-center, double blind, randomized controlled clinical trial in a 2:1 allocation of Test versus sham Control. In addition, a single arm of 15 non-randomized subjects will be added to study the Pharmacokinetics of the drug. The objectives of the study are to assess the efficacy of Optilume BPH Catheter System to alleviate LUTS believed to be secondary to BPH (LUTS/BPH) and to evaluate the safety of Optilume BPH Catheter System in the treatment of LUTS/BPH.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Optilume BPH Catheter System, Optilume Sham Device
- Keywords
- BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume
- Medical subject headings
- Prostatic Hyperplasia, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optilume BPH Catheter SystemDevice
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
Optilume Sham DeviceDevice
21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
| Study group | Role | What they receive |
|---|---|---|
| Optilume™ BPH Catheter System | Experimental | The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. Receives: Device: Optilume BPH Catheter System |
| Sham Device | Sham comparator | The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath. Receives: Device: Optilume Sham Device |
| Pharmacokinetics Optilume Arm | Experimental | A single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. These subjects will be treated with the Optilume BPH Catheter System Receives: Device: Optilume BPH Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
The primary efficacy endpoint was the improvement in International Prostate Symptom Score (IPSS) at 12 months in the Optilume BPH arm compared to the improvement in IPSS at 3 months in the Sham arm with a super-superiority margin on 25%.
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.
The IPSS also includes an eighth question that is designed to assess the degree of "bother" associated with the subject's urinary symptoms. Answers range from "delighted" to "terrible" (0-6). This question is not included in the calculation of the main IPSS score.
Measured: 12 months
Number of Participants With Major Device Related Serious Complications
Rate of major device-related serious complications. A major device-related serious complication is defined as any of the following events through 12 months:
- Device-related rectal fistula or GI fistula
- Device-related formation of fistula between the rectum and urethra
- Device-related new onset severe urinary retention lasting > 14 consecutive days post-healing
- Device-related unresolved new onset stress urinary incontinence by 90 days
- Device-related bleeding requiring transfusion
- Device-related urethra or prostatic capsule rupture requiring surgical intervention
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 posted18 Oct 2019
- Study start5 Feb 2020
- Primary completion23 Aug 2022
- Study completionMay 2027 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized study with a non-randomized, Pharmacokinetics arm. Subjects randomized to the Control arm are allowed to crossover to the Test arm if they meet the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. Up to 625 subjects will be enrolled (i.e. consented) in the study in order to identify 162 eligible subjects (147 randomized subjects and 15 Pharmacokinetic subjects)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven A Kaplan, MD, Principal investigator, Mount Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131907
- Sponsor's protocol ID
- PR1087
- Acronym
- PINNACLE
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2019
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaplan SA, Moss JL, Freedman SJ. Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study). Prostate Cancer Prostatic Dis. 2024 Sep;27(3):531-536. doi: 10.1038/s41391-024-00833-z. Epub 2024 Apr 29.
PubMed 38684918
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
- ClinicalTrials.gov ID
- NCT04131907
- Acronym / sponsor ID
- PINNACLE / PR1087
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
Detailed description
This is a prospective, multi-center, double blind, randomized controlled clinical trial in a 2:1 allocation of Test versus sham Control. In addition, a single arm of 15 non-randomized subjects will be added to study the Pharmacokinetics of the drug. The objectives of the study are to assess the efficacy of Optilume BPH Catheter System to alleviate LUTS believed to be secondary to BPH (LUTS/BPH) and to evaluate the safety of Optilume BPH Catheter System in the treatment of LUTS/BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized study with a non-randomized, Pharmacokinetics arm. Subjects randomized to the Control arm are allowed to crossover to the Test arm if they meet the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. Up to 625 subjects will be enrolled (i.e. consented) in the study in order to identify 162 eligible subjects (147 randomized subjects and 15 Pharmacokinetic subjects)
| Arm | Type | Receives |
|---|---|---|
| Optilume™ BPH Catheter System | Experimental | Device: Optilume BPH Catheter SystemThe Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. |
| Sham Device | Sham comparator | Device: Optilume Sham DeviceThe Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath. |
| Pharmacokinetics Optilume Arm | Experimental | Device: Optilume BPH Catheter SystemA single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. These subjects will be treated with the Optilume BPH Catheter System |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male subject 50-80 years of age who has symptomatic BPH
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
- Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
- Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
Key exclusion criteria (42 listed)
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
- Unwilling to abstain or use protected sex for the first 30 days post treatment
- Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
- Presence of an artificial urinary sphincter 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
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 Catheter SystemThe Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. | Device | Optilume™ BPH Catheter System, Pharmacokinetics Optilume Arm |
| Optilume Sham Device21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation) | Device | Sham Device |
Primary outcome
Number of Participants With >30% Improvement in the International Prostate Symptom Score (IPSS)
Time frame: 12 months
The primary efficacy endpoint was the improvement in International Prostate Symptom Score (IPSS) at 12 months in the Optilume BPH arm compared to the improvement in IPSS at 3 months in the Sham arm with a super-superiority margin on 25%. 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. The IPSS also includes an eighth question that is designed to assess the degree of "bother" associated with the subject's urinary symptoms. Answers range from "delighted" to "terrible" (0-6). This question is not included in the calculation of the main IPSS score.
Number of Participants With Major Device Related Serious Complications
Time frame: 12 months
Rate of major device-related serious complications. A major device-related serious complication is defined as any of the following events through 12 months: * Device-related rectal fistula or GI fistula * Device-related formation of fistula between the rectum and urethra * Device-related new onset severe urinary retention lasting > 14 consecutive days post-healing * Device-related unresolved new onset stress urinary incontinence by 90 days * Device-related bleeding requiring transfusion * Device-related urethra or prostatic capsule rupture requiring surgical intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38684918Kaplan SA, Moss JL, Freedman SJ. Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study). Prostate Cancer Prostatic Dis. 2024 Sep;27(3):531-536. doi: 10.1038/s41391-024-00833-z. Epub 2024 Apr 29.
- 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.
Steven A Kaplan, MD principal investigator
Mount Sinai Health System
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optilume BPH Catheter System in people with Benign Prostatic Hyperplasia, run by Urotronic Inc. at 21 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 42 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 9 Apr 2025). 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 Participants With >30% Improvement in the International Prostate Symptom Score (IPSS) (time frame: 12 months). 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 NCT04131907, 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 30 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.