Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)

April 27, 2026 updated by: Urotronic Inc.
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
    • Florida
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Completed
        • Regional Urology
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Completed
        • Chesapeake
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Freedman Urology
        • Contact:
    • New Jersey
      • Millburn, New Jersey, United States, 07041
        • Completed
        • New Jersey Urolgy
    • New York
      • Cheektowaga, New York, United States, 14225
    • Texas
      • Dallas, Texas, United States, 75231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male subjects between 22 and 65 years of age
  2. 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
  3. Subject is willing to provide written informed consent and comply with study required follow-up assessments

  4. Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):

    1. total sperm ≥39 million
    2. sperm concentration ≥15 million/mL
    3. total motility ≥40%
    4. progressive motility ≥32%
    5. morphology ≥4%

Exclusion Criteria:

  1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds
  2. Subjects with a history of vasectomy or other condition that may inhibit semen/sperm production or ejaculatory function
  3. Subjects currently taking 5-alpha reductase inhibitors, alpha-blockers, selective serotonin reuptake inhibitors, or hormone replacement therapy without appropriate washout
  4. Subject is unwilling to abstain or utilize a condom for 30 days after the procedure
  5. Subject is unwilling to utilize highly effective contraception for 6 months after the procedure if partner is of childbearing potential
  6. History of cancer in any body system that is not considered in complete remission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optilume Urethral DCB
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.
Combination product: Optilume Urethral DCB
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 3-months
Average Change in Sperm Concentration from baseline to 3-months
3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Safety Endpoint
Time Frame: 6-months
Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urotronic Inc.

Collaborators

Laborie Medical Technologies Inc.

Investigators

  • Principal Investigator: Karl Coutinho, MD, New Jersey Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR1275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe