A Phase 4 interventional study of Optilume Urethral DCB in Urethral Stricture, sponsored by Urotronic Inc.. Active, not recruiting at 9 sites in United States. Open to male participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Urotronic Inc. · Phase 4, Interventional, and Treatment
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
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.
Subject able to provide viable semen samples and baseline semen quality characteristics are above reference values based on below criteria (average of 2 samples):
Exclusion Criteria:
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
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 Safety Endpoint
Average Change in Sperm Concentration from baseline to 3-months
Time frame: 3-months
Secondary Safety Endpoint
Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months
Time frame: 6-months
Plan to share: No
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Urotronic Inc.