Urethral StricturePhase 4STREAMNCT05383274
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
A Phase 4 study testing Optilume Urethral DCB in people with Urethral Stricture, run by Urotronic Inc. at 9 sites in United States.
Trial summary
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age. Read more about this study
- Who is it for?
- Ages 22 to 65 years, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Optilume Urethral DCB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Feb 2022to 30 Dec 2027
- Phase
- Phase 4
- 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 22 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects between 22 and 65 years of age
- Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
- Subject is willing to provide written informed consent and comply with study required follow-up assessments
- Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
- total sperm ≥39 million
- sperm concentration ≥15 million/mL
Show all 9Show fewer
- total motility ≥40%
- progressive motility ≥32%
- morphology ≥4%
Who cannot join
- Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
- Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
- History of cancer in any body system that is not considered in complete remission
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Western New York
Cheektowaga, New York, 14225
Urology Clinics of North Texas
Dallas, Texas, 75231
Chesapeake
Hanover, Maryland, 21076
Freedman Urology
Las Vegas, Nevada, 89144
Arkansas Urology
Little Rock, Arkansas, 72211
New Jersey Urolgy
Millburn, New Jersey, 07041
Orlando Health
Orlando, Florida, 32806
Regional Urology
Shreveport, Louisiana, 71106
Florida Urology
Tampa, Florida, 33615
About this study
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Read the detailed description
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.
- Conditions
- Urethral Stricture
- Being tested
- Optilume Urethral DCB
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optilume Urethral DCBCombination product
The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
| Study group | Role | What they receive |
|---|---|---|
| Optilume Urethral DCB | Experimental | The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. Receives: Combination Product: Optilume Urethral DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Average Change in Sperm Concentration from baseline to 3-months
Measured: 3-months
Secondary outcomes (1)
Secondary Safety Endpoint
Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start14 Feb 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laborie Medical Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Karl Coutinho, MD, Principal investigator, New Jersey Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383274
- Sponsor's protocol ID
- PR1275
- Acronym
- STREAM
- Status last verified
- Sep 2026
- First submitted
- 16 May 2022
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
- ClinicalTrials.gov ID
- NCT05383274
- Acronym / sponsor ID
- STREAM / PR1275
- Conditions
- Urethral Stricture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laborie Medical Technologies Inc.
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 May 2022 (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.
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
Detailed description
Male subject diagnosed with a stricture in the anterior urethra that can be treated with the Optilume Urethral DCB. Thirty-Four (34) subjects will be enrolled at up to ten (10) sites in the United States. Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months post-treatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function. Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Subjects with an abnormal semen quality result at 6 months will have an additional assessment at 12 months post-treatment and periodically thereafter until results return to normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optilume Urethral DCB | Experimental | Combination Product: Optilume Urethral DCBThe Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male subjects between 22 and 65 years of age
- Subject diagnosed with a stricture in the anterior urethra that is able to be treated with the Optilume Urethral DCB in accordance with the approved Instructions for Use
- Subject is willing to provide written informed consent and comply with study required follow-up assessments
- Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
Key exclusion criteria (6 listed)
- Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
- Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
- Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
- Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
- Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
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 Urethral DCBThe Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation. | Combination product | Optilume Urethral DCB |
Primary outcome
Primary Safety Endpoint
Time frame: 3-months
Average Change in Sperm Concentration from baseline to 3-months
1 secondary outcome
Secondary Safety Endpoint
Time frame: 6-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 21 Sep 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.
Karl Coutinho, MD principal investigator
New Jersey Urology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Optilume Urethral DCB in people with Urethral Stricture, run by Urotronic Inc. at 9 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 9 inclusion and 6 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary Safety Endpoint (time frame: 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 21 Sep 2026.