Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

Phase 4

Recruiting

• Conditions: Urethral Stricture
• Interventions: Combination Product: Optilume Urethral DCB

• Registration Number: NCT05383274
• Lead Sponsor: Urotronic Inc.

Brief Summary

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 Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optilume Urethral DCB	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.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	3-months	Average Change in Sperm Concentration from baseline to 3-months

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Endpoint	6-months	Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months

Trial Locations

Locations (9)

Chesapeake; 🇺🇸 Hanover, Maryland, United States

Arkansas Urology; 🇺🇸 Little Rock, Arkansas, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Florida Urology; 🇺🇸 Tampa, Florida, United States

Regional Urology; 🇺🇸 Shreveport, Louisiana, United States

Freedman Urology; 🇺🇸 Las Vegas, Nevada, United States

New Jersey Urolgy; 🇺🇸 Millburn, New Jersey, United States

Western New York; 🇺🇸 Cheektowaga, New York, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States