NCT05383274

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
8mo left

Started Feb 2022

Longer than P75 for phase_4

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Feb 2022Dec 2026

Study Start

First participant enrolled

February 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

May 16, 2022

Last Update Submit

April 27, 2026

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (1)

  • Primary Safety Endpoint

    Average Change in Sperm Concentration from baseline to 3-months

    3-months

Secondary Outcomes (1)

  • Secondary Safety Endpoint

    6-months

Study Arms (1)

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.

Combination Product: Optilume Urethral DCB

Interventions

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.

Optilume Urethral DCB

Eligibility Criteria

Age22 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen between 22 and 65 years of age.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • total motility ≥40%
  • progressive motility ≥32%
  • morphology ≥4%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Arkansas Urology

Little Rock, Arkansas, 72211, United States

RECRUITING

Orlando Health

Orlando, Florida, 32806, United States

RECRUITING

Florida Urology

Tampa, Florida, 33615, United States

RECRUITING

Regional Urology

Shreveport, Louisiana, 71106, United States

COMPLETED

Chesapeake

Hanover, Maryland, 21076, United States

COMPLETED

Freedman Urology

Las Vegas, Nevada, 89144, United States

RECRUITING

New Jersey Urolgy

Millburn, New Jersey, 07041, United States

COMPLETED

Western New York

Cheektowaga, New York, 14225, United States

RECRUITING

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Karl Coutinho, MD

    New Jersey Urology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Johnson, MS

CONTACT

bjohnson@laborie.com

Reem Ennenga

CONTACT

612-747-4183rennenga@laborie.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 20, 2022

Study Start

February 14, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(9)