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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Progress Adequate
Application Number /
Requirement Number
P210020 / PAS003
Date Original Protocol Accepted 01/27/2022
Date Current Protocol Accepted 09/29/2022
Study Name STREAM PAS (PR1275)
Device Name Optilume Urethral Drug Coated Balloon
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The “Evaluation of the Impact of the Optilume® Urethral Drug Coated Balloon (DCB) on Semen Characteristics Post-Treatment” study (PR1275 Rev A) is a single-arm, prospective study assessing semen quality after treatment with the Optilume® Urethral DCB in men younger than 55 years of age with a stricture in the anterior urethra that can be treated with the Optilume®.

The objective of the study is to determine if treatment with the Optilume® Urethral DCB negatively impacts semen characteristics in men with normal baseline semen characteristics.

The study duration is anticipated to be up to 3 years.
Study Population The study will enroll 34 patients at up to 5 sites in the United States and will be open to male subjects between 22 and 55 years of age who meet the selection criteria, as shown below.
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):
ejaculate volume greater than or equal to 1.5mL
total sperm greater than or equal to 39 million
sperm concentration greater than or equal to 15 million/mL
total motility greater than or equal to 40%
morphology greater than or equal to 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.
Sample Size Number of subjects: 34 subjects
The sample size for the study is based on the primary effectiveness endpoint using the following assumptions:
An anticipated standard deviation of 60%
Estimated based on a performance goal of not more than a 30% decrease from baseline
Statistical power of approximately 80%
A sample size of 34 subjects was estimated based on a performance goal of not more than a 30% decrease from baseline, with an anticipated standard deviation of 60%, and an estimate of a 0% decrease from baseline after treatment with the Optilume Urethral DCB, and 80% power. NOTE: Median change from baseline at 3 months in ROBUST III was +/- 8% (-2% for those with ‘normal’ baseline sperm concentration values). Calculations are based on a one-sided 0.025 alpha level t-test for a mean.
No. of Sites: 5 sites
Sites location: United States
Key Study Endpoints Efficacy Endpoints
Primary Efficacy Endpoints
There are no hypothesis tested efficacy endpoints
Ancillary Efficacy Endpoints
Improvement in IPSS Over Time
Improvement in Qmax and PVR Over Time
Safety Endpoints
Primary Safety Endpoint
Average Change in Sperm Concentration from Baseline
Secondary Safety Endpoint
Proportion of Subjects Experiencing greater than or equal to 50% Decrease in Sperm Concentration from Baseline
Ancillary Safety Endpoint
Change in Semen Characteristics from Baseline
Change in Erectile Function & Overall Satisfaction IIEF Sub-Scores
Device and Procedure Related Adverse Events
Follow-up Visits and Length of Follow-up Semen quality parameters will be assessed at Baseline, 3 months, and 6 months post-treatment. Parameters will include ejaculate volume (mL), sperm concentration (million/mL), total sperm per ejaculate (million), motility (% of sperm that is motile), progressive motility (%), and morphology (% normal). Values at each timepoint will be the average of two samples collected within 1-2 weeks of each other.
Clinical follow-up will be conducted at 30 days, 3 months, 6 months, and 12 months posttreatment evaluating Lower Urinary Tract Symptoms (LUTS), sexual function, and voiding function.
The total length of follow-up for each subject is one year.
Interim or Final Data Summary
Actual Number of Patients Enrolled 0
Actual Number of Sites Enrolled 3
Patient Follow-up Rate NA
Final Safety Findings NA
Final Effect Findings NA

STREAM PAS (PR1275) Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 06/03/2022 06/03/2022 On Time
1 year report 12/03/2022    
18 month report 06/03/2023    
2 year report 12/03/2023    
3 year report 12/02/2024    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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