Benign Prostatic HyperplasiaPEAKNCT06312722
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
A study testing Optilume® BPH Catheter System in people with Benign Prostatic Hyperplasia, run by Urotronic Inc. at 7 sites in United States.
Trial summary
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. 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?
- Optilume® BPH Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Feb 2024to 7 Feb 2031
- 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
- Male subject ≥ 50 years old
- Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
- Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
- Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL
- Willing to provide informed consent and comply with protocol required follow-up
Who cannot join
- Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
- Presence of an artificial urinary sphincter, penile prosthesis, 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
- Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is > 4 ng/mL with free PSA < 25%.
- Active urinary tract infection (UTI) confirmed by culture
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
Show all 14Show fewer
- History of overt urinary incontinence requiring the use of pads
- Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- Current post-void residual volume (PVR) > 300 mL or catheter dependent bladder drainage
- Known poor detrusor muscle function (e.g., Qmax < 5 mL/sec)
- Active bladder, ureteral, or urethral stones or stone passage within the last 3 months
- Current poorly controlled diabetes (i.e., hemoglobin A1c ≥ 8%)
- Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- Obstructive median lobe in the opinion of the investigator
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Steve Madej contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Midtown Urology Associates
Austin, Texas, 78705
Andrew Barger, APRN, 512-451-7935, APBarger@cimplify.net
Michael Trotter, MD
- Recruiting
Houston Methodist Urology Associates
Houston, Texas, 77030
Miguel Valdivia Y Alvarado, 713-441-6455, mvaldiviayalvarado@houstonmethodist.org
Ricardo Gonzalez, MD
- Recruiting
Sheldon Freedman MD, Ltd
Las Vegas, Nevada, 89144
Danielle Freedman, 702-732-0282 ext. 232, drfreedman@msn.com
Sheldon Freedman, MD
- Recruiting
Arkansas Urology
Little Rock, Arkansas, 72211
Katie O'Brien, 501-830-8050, katie@arkansasurology.com
Jeffrey Marotte, MD
- Recruiting
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, 71106
Kayla Telano, 318-383-4319, kayla.telano@ochsnerlsuhs.org
Jared Moss, MD
- Recruiting
Oregon Urology Institute
Springfield, Oregon, 97477
Maxim DiMarco, 541-284-5508, mdimarco@oregonurology.com
David DiMarco, MD
- Recruiting
Florida Urology Partners, LLP
Tampa, Florida, 33615
Linda Seibert, 239-223-4488, linda@gulfcoastcta.com
Osvaldo Padron, MD
About this study
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Read the detailed description
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
STUDY ENDPOINTS
Primary Efficacy Endpoint:
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.
Primary Safety Endpoint:
The primary safety endpoint is the freedom from composite treatment-related adverse SAEs.
Key Secondary Safety Endpoint (Semen Sub-Study Only):
The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).
Ancillary Endpoints:
Ancillary Safety Endpoint:
- Frequency and severity of treatment-related AEs Adverse events will be collected and assessed for relatedness to the device and the procedure as well as for severity. The Clavien-Dindo severity grading scale is a commonly used criteria in the urology community. An independent medical monitor will adjudicate all treatment-related events.
- Frequency and severity of all AEs All adverse events will be summarized and reported, regardless of relatedness to the device or procedure.
- Change from baseline in semen characteristics over time (semen sub-study only) Semen characteristics (concentration, count, motility) will be summarized at each follow-up, including change from baseline values. Reported values for each subject will represent an average of 2 samples collected at each timepoint. Summary statistics will be based on reported values for each subject at each timepoint.
- Proportion of subjects experiencing ≥50% decrease in sperm concentration from baseline The proportion of subjects experiencing ≥50% decrease in sperm concentration from baseline to 3, 6 and 12 months will be reported. Ancillary Efficacy Endpoints:
- Improvement in IPSS over time The IPSS tool is the most commonly reported symptom score for obstructive urinary symptoms secondary to BPH. Average IPSS scores, absolute change from baseline, and percent change from baseline will be reported at each follow-up timepoint.
- Improvement in ICS male SF over time The International Continence Society (ICS) male short form (SF) has three domains to assess urinary symptoms; voiding symptoms (e.g., hesitancy, incomplete voiding, etc.), storage symptoms (e.g., frequency), and leakage symptoms. Average total scores and average scores for each domain, along with changes from baseline, will be reported at each follow-up timepoint.
- Improvement in Qmax over time Uroflowmetry represents an objective measure of relief of obstruction. Average peak urinary flow rate (Qmax) and change from baseline will be reported at each follow-up timepoint.
- Improvement in PVR over time Residual urine in the bladder due to incomplete emptying is an important clinical consideration in subjects with obstructive BPH. Average PVR and change from baseline will be reported at each follow-up timepoint.
- Freedom from repeat intervention (time-to-event) The proportion of subjects free from repeat surgical or endoscopic intervention for BPH will be reported over time utilizing the Kaplan-Meier method.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Optilume® BPH Catheter System
- 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 Catheter SystemDevice
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Other | 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.
Change in International Prostate Symptom Score (IPSS)
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.
The first seven questions in the International Prostate Symptom Score (IPSS) questionnaire 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: Baseline to 12 months
Rate of a composite of treatment-related serious adverse events (SAEs)
The primary safety endpoint is the rate of a composite of the specified treatment-related serious adverse events through 3 months post-treatment:
- De novo severe urinary retention lasting >14 days post-procedure
- De novo severe stress urinary incontinence requiring surgical management
- Formation of a fistula between the rectum and urethra
- Perforation of the rectum or GI tract
- Bleeding requiring transfusion or endoscopic intervention
Measured: 3 months
Secondary outcomes (1)
Change in Sperm Concentration
For the Semen Sub-Study, the average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start7 Feb 2024
- Primary completion7 Feb 2031 (estimated)
- Study completion7 Feb 2031 (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.
- 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
- Model description
- Prospective, single-arm, multi-center, post market clinical trial
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kaplan, MD, FACS, Principal investigator, Professor of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312722
- Sponsor's protocol ID
- PR1309
- Acronym
- PEAK
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
- ClinicalTrials.gov ID
- NCT06312722
- Acronym / sponsor ID
- PEAK / PR1309
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 7 Feb 2031 (estimated)
- Study completion
- 7 Feb 2031 (estimated)
- First posted
- 15 Mar 2024 (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 goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Detailed description
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
STUDY ENDPOINTS
Primary Efficacy Endpoint:
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.
Primary Safety Endpoint:
The primary safety endpoint is the freedom from composite treatment-related adverse SAEs.
Key Secondary Safety Endpoint (Semen Sub-Study Only):
The average change from baseline in sperm concentration at 13 weeks (3 months) post-procedure will be compared against a performance goal of -30% (30% decrease from baseline).
Ancillary Endpoints:
Ancillary Safety Endpoint:
- Frequency and severity of treatment-related AEs Adverse events will be collected and assessed for relatedness to the device and the procedure as well as for severity. The Clavien-Dindo severity grading scale is a commonly used criteria in the urology community. An independent medical monitor will adjudicate all treatment-related events.
- Frequency and severity of all AEs All adverse events will be summarized and reported, regardless of relatedness to the device or procedure.
- Change from baseline in semen characteristics over time (semen sub-study only) Semen characteristics (concentration, count, motility) will be summarized at each follow-up, including change from baseline values. Reported values for each subject will represent an average of 2 samples collected at each timepoint. Summary statistics will be based on reported values for each subject at each timepoint.
- Proportion of subjects experiencing ≥50% decrease in sperm concentration from baseline The proportion of subjects experiencing ≥50% decrease in sperm concentration from baseline to 3, 6 and 12 months will be reported. Ancillary Efficacy Endpoints:
- Improvement in IPSS over time The IPSS tool is the most commonly reported symptom score for obstructive urinary symptoms secondary to BPH. Average IPSS scores, absolute change from baseline, and percent change from baseline will be reported at each follow-up timepoint.
- Improvement in ICS male SF over time The International Continence Society (ICS) male short form (SF) has three domains to assess urinary symptoms; voiding symptoms (e.g., hesitancy, incomplete voiding, etc.), storage symptoms (e.g., frequency), and leakage symptoms. Average total scores and average scores for each domain, along with changes from baseline, will be reported at each follow-up timepoint.
- Improvement in Qmax over time Uroflowmetry represents an objective measure of relief of obstruction. Average peak urinary flow rate (Qmax) and change from baseline will be reported at each follow-up timepoint.
- Improvement in PVR over time Residual urine in the bladder due to incomplete emptying is an important clinical consideration in subjects with obstructive BPH. Average PVR and change from baseline will be reported at each follow-up timepoint.
- Freedom from repeat intervention (time-to-event) The proportion of subjects free from repeat surgical or endoscopic intervention for BPH will be reported over time utilizing the Kaplan-Meier method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, multi-center, post market clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Other | Device: Optilume® BPH Catheter SystemOptilume BPH Catheter System |
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 old
- Diagnosed with lower urinary tract symptoms (LUTS) secondary to obstructive benign prostatic hyperplasia (BPH)
- Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use
- Prostate volume < 80 g with a prostatic urethral length between 32-55 mm as determined by trans-rectal ultrasound (TRUS)
- International Prostate Symptom Score (IPSS) ≥ 13
Key exclusion criteria (14 listed)
- Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
- Presence of an artificial urinary sphincter, penile prosthesis, 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
- Confirmed or suspected malignancy of prostate or bladder. Negative prostate biopsy required within 6 months of enrollment if PSA at baseline is > 4 ng/mL with free PSA < 25%.
- Active urinary tract infection (UTI) confirmed by culture
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 Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body. | Device | Study Arm |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline to 12 months
The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months. The first seven questions in the International Prostate Symptom Score (IPSS) questionnaire 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.
Rate of a composite of treatment-related serious adverse events (SAEs)
Time frame: 3 months
The primary safety endpoint is the rate of a composite of the specified treatment-related serious adverse events through 3 months post-treatment: * De novo severe urinary retention lasting >14 days post-procedure * De novo severe stress urinary incontinence requiring surgical management * Formation of a fistula between the rectum and urethra * Perforation of the rectum or GI tract * Bleeding requiring transfusion or endoscopic intervention
1 secondary outcome
Change in Sperm Concentration
Time frame: Baseline to 3 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 10 Jul 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.
Steve Madej contact
Steven Kaplan, MD, FACS principal investigator
Professor of Urology
7 sites in 1 country: 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 7 sites 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 14 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: looking for participants now, as of the sponsor's last update on 10 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 7 sites 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?
Contact Kaitlyn Palm (612-816-0068, kpalm@laborie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline to 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?
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 10 Jul 2026.