Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Urethral Stricture Clinical Trial

— STREAM  

Official title:

Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05383274
• Other study ID #: PR1275
• Status: Recruiting
• Phase: Phase 4
• Start date: February 14, 2022
• Est. completion date: March 30, 2026

Study information

• Verified date: May 2024
• Source: Urotronic Inc.
• Contact: Brenda Johnson
• Phone: 17632857488
• Email: bjohnson[@]laborie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Urethral Stricture

Intervention

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.

Locations

Country	Name	City	State
United States	Western New York	Cheektowaga	New York
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Chesapeake	Hanover	Maryland
United States	Freedman Urology	Las Vegas	Nevada
United States	Arkansas Urology	Little Rock	Arkansas
United States	New Jersey Urolgy	Millburn	New Jersey
United States	Orlando Health	Orlando	Florida
United States	Regional Urology	Shreveport	Louisiana
United States	Florida Urology	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Urotronic Inc.	Laborie Medical Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Average Change in Sperm Concentration from baseline to 3-months	3-months
Secondary	Secondary Safety Endpoint	Proportion of Subjects Experiencing =50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months	6-months