Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters (STREAM)

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    34
  • sponsor
    Urotronic Inc.
Updated on 4 June 2022

Summary

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 55 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 five (5) 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.

Details
Condition Urethral Stricture
Treatment Optilume Urethral DCB
Clinical Study IdentifierNCT05383274
SponsorUrotronic Inc.
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male subjects between 22 and 55 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 WHO criteria (average of 2 samples)
ejaculate volume ≥1.5mL
total sperm ≥39 million
sperm concentration ≥15 million/mL
total motility ≥40%
progressive motility ≥32%
morphology ≥4%

Exclusion Criteria

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
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
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