Benign Prostatic HyperplasiaAPEXNCT06560476
OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
An observational study of Benign Prostatic Hyperplasia, run by Urotronic Inc. at 8 sites in United States.
Trial summary
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Data collection
- How many people
- 500 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Mar 2024to 30 Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.
Who may be able to join
- 1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
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
- Confirmed or suspected malignancy of prostate or bladder.
- Active urinary tract infection (UTI)
- Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Midtown Urology
Austin, Texas, 78705
Good Samaritan Hospital
Corvallis, Oregon, 97330
Kearney Urology Center
Kearney, Nebraska, 68847
Sheldon Freedman, Ltd
Las Vegas, Nevada, 89144
The Urology Center, P.C.
Omaha, Nebraska, 68144
Northwell Health - Smith Institute of Urology
Syosset, New York, 11791
Florida Urology Partners
Tampa, Florida, 33615
Potomac Urology
Woodridge, Virginia, 22191
About this study
Official title: A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Data collection
- Keywords
- BPH, Drug Coated Balloon, DCB, Prostate, LUTS, Optilume
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | This is the data collection study arm. There is no other arm in the study. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.
It is a validated, reproducible scoring system to assess disease severity and response to therapy.
The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
Measured: Baseline to 12 months
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
Measured: Baseline to 12 months
Secondary outcomes (5)
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.
Measured: From baseline to through study completion, an average of 2 years.
Change 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.
The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms.
It is a validated, reproducible scoring system to assess disease severity and response to therapy.
The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
Measured: From baseline to through study completion, an average of 2 years.
Change in Qmax (mL per second) 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.
Uroflowmetry assesses flow pattern, flow curve shape, maximum urinary flow (Qmax), voided volume (VV), voiding time (VT), PVR volume (PVR). A minimum of 150ml is required to provide an accurate assessment in men
Measured: From baseline to through study completion, an average of 2 years.
Change 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.
Post-void residual volume (PVR) is the amount of urine retained in the bladder after a voluntary void and functions as a diagnostic tool. A PVR can be used to assess many disease processes, including but not limited to neurogenic bladder, cauda equina syndrome, urinary outlet obstruction, mechanical obstruction, medication-induced urinary retention, postoperative urinary retention, and urinary tract infections. The PVR may be determined through urinary catheterization, a portable dedicated bladder scanner, or a formal ultrasound examination.
Measured: From baseline to through study completion, an average of 2 years.
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.
Measured: From baseline to through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start30 Mar 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560476
- Sponsor's protocol ID
- PR1326
- Acronym
- APEX
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
- ClinicalTrials.gov ID
- NCT06560476
- Acronym / sponsor ID
- APEX / PR1326
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, Drug Coated Balloon, DCB, Prostate, LUTS, Optilume
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Aug 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.
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | – | Other: Data collectionThis is the data collection study arm. There is no other arm in the study. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.
Key inclusion criteria (1 listed)
- 1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
Key exclusion criteria (5 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
- Confirmed or suspected malignancy of prostate or bladder.
- Active urinary tract infection (UTI)
- Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
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 |
|---|---|---|
| Data collectionSubject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system. | Other | Study Arm |
Primary outcome
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
Time frame: Baseline to 12 months
The primary efficacy endpoint is the average IPSS change from baseline to 12 months. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
Time frame: Baseline to 12 months
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
5 secondary outcomes
Frequency and severity of treatment-related AEs
Time frame: From baseline to through study completion, an average of 2 years.
Change in IPSS over time
Time frame: From baseline to through study completion, an average of 2 years.
Change in Qmax (mL per second) over time
Time frame: From baseline to through study completion, an average of 2 years.
Change in PVR over time
Time frame: From baseline to through study completion, an average of 2 years.
Freedom from repeat intervention (time-to-event)
Time frame: From baseline to through study completion, an average of 2 years.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Urotronic Inc. at 8 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 1 inclusion and 5 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 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 8 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?
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?
The primary efficacy endpoint is the average IPSS change from baseline to 12 months. (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.