Clinical trial NCT05383274: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Official title: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Urethral Stricture
Lead sponsor: Urotronic Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laborie Medical Technologies Inc.
First posted: 2022-05-20
Enrollment: 34
Sex: MALE
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 3-months
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 6-months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Tampa
country: United States
facility: Florida Urology
state: Florida
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake
state: Maryland
city: Las Vegas
country: United States
facility: Freedman Urology
state: Nevada
city: Millburn
country: United States
facility: New Jersey Urolgy
state: New Jersey
city: Cheektowaga
country: United States
facility: Western New York
state: New York
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
Study officials:
affiliation: New Jersey Urology
name: Karl Coutinho, MD
role: PRINCIPAL_INVESTIGATOR
References: