STREAM: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters

• Sponsor: Urotronic Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05383274
• Collaborator: (none)
• Enrollment: 34
• Locations: 5
• Arm: 1
• Anticipated Duration (Months): 30.5
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 55 years of age.

Condition or Disease	Intervention/Treatment	Phase
Urethral Stricture	Combination Product: Optilume Urethral DCB	Phase 4

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 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
• Actual Study Start Date: Feb 14, 2022
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Primary Safety Endpoint [3-months]

   Average Change in Sperm Concentration from baseline to 3-months

Secondary Outcome Measures

1. Secondary Safety Endpoint [6-months]

   Proportion of Subjects Experiencing ≥50% Decrease in Sperm Concentration from Baseline at 3 and 6 Months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male subjects between 22 and 55 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 WHO criteria (average of 2 samples):

5. ejaculate volume ≥1.5mL

6. total sperm ≥39 million

7. sperm concentration ≥15 million/mL

8. total motility ≥40%

9. progressive motility ≥32%

10. 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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Urology	Tampa	Florida	United States	33615
2	Regional Urology	Shreveport	Louisiana	United States	71106
3	Chesapeake	Hanover	Maryland	United States	21076
4	New Jersey Urolgy	Millburn	New Jersey	United States	07041
5	Western New York	Cheektowaga	New York	United States	14225

Sponsors and Collaborators

• Urotronic Inc.

Investigators

• Principal Investigator: Karl Coutinho, MD, New Jersey Urology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Urotronic Inc.
• ClinicalTrials.gov Identifier: NCT05383274
• Other Study ID Numbers: PR1275
• First Posted: May 20, 2022
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urethral Stricture

Study Results

No Results Posted as of May 20, 2022