Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)

Urotronic

Status and phase: Enrolling; Phase 4

Conditions: Urethral Stricture

Treatments: Combination Product: Optilume Urethral DCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT05383274

PR1275

Details and patient eligibility

About

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.

Full 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.

Enrollment: 34 estimated patients

Sex: Male

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Optilume Urethral DCB

Experimental group

Description:

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.

Treatment:

Combination Product: Optilume Urethral DCB