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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210020 / PAS001 |
| Date Original Protocol Accepted |
01/19/2022
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| Date Current Protocol Accepted |
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| Study Name |
ROBUST-LT Post-Approval Study (PR1277)
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| Device Name |
Optilume Urethral Drug Coated Balloon
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The ROBUST-LT PAS is a continuation of the ROBUST clinical program (ROBUST I, II and III clinical studies). ROBUST-LT is designed to verify the continued safety and effectiveness for the Optilume Urethral Drug-Coated Balloon (DCB). It is intended to assess durability of outcomes after 1 year follow-up of the 194 patients currently enrolled in the ROBUST clinical program. Each patient’s follow-up will be continued out to 5 years post-treatment.
The harmonized primary effectiveness endpoint is defined as a patient experiencing a =30% improvement in International Prostate Symptom Score (IPSS) from baseline without the need for additional intervention. Additional harmonized endpoints include freedom from repeat intervention, uroflowmetry, IPSS, adverse event summary, and International Index of Erectile Function (IIEF). The primary safety endpoint is mortality rate that will be calculated for each study and reported as the number of deaths per 100 patient years. All adverse event (AE) data will be collected. Progress reports will be submitted to the FDA annually after PMA approval.
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| Study Population |
ROBUST I: Adult men 18 years of age or older with anterior urethral stricture = 2 cm in length and with = 1 prior dilation.
ROBUST II: Adult men 18 years of age or older with anterior urethral strictures = 3 cm in length and with = 2 prior dilations.
ROBUST III: Adult men 18 years of age or older with with anterior urethral strictures = 3 cm in length in subjects with = 2 prior dilations
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| Sample Size |
No. of subjects: 194 subjects
No assumptions for sample size estimation. Enrollment is complete.
No. of sites: ROBUST I (4 sites), ROBUST II (5 sites), ROBUST III (22 sites).
Sites location: US and the following countries: ROBUST I (Panama and Dominican Republic), ROBUST II (U.S.), ROBUST III (U.S. and Canada).
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| Key Study Endpoints |
Safety Endpoints
Primary: The mortality rate that will be calculated for each study and reported as the number of deaths per 100 patient years.
Secondary: Frequency and severity of adverse events, erectile function (EF), orgasmic function (OF), and overall satisfaction IIEF subdomains.
Effectiveness Endpoints
Primary: Responder rate: A patient experiencing a =30% improvement in International Prostate Symptom Score (IPSS) from baseline without the need for additional intervention.
Secondary: Additional harmonized endpoints include freedom from repeat intervention, uroflowmetry (Qmax and PVR), IPSS, adverse event summary, and International Index of Erectile Function (IIEF).
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| Follow-up Visits and Length of Follow-up |
Each subject will be followed annually for 5 years with assessments as described in the Study Endpoints section, above.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
194
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| Actual Number of Sites Enrolled |
31
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| Patient Follow-up Rate |
Subjects are still undergoing annual follow up per the previous approved protocol. ROBUST I completed 5 year follow up plan on September 2022. ROBUST II is projected to complete annual follow up report on April 2024. ROBUST III is projected to complete annual follow up from June 2025 - February 2026.
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| Final Safety Findings |
The rate of mortality in the total Optilume cohort is 0.5 which is consistent with the expected rate for males in this age rage (1.7 deaths per 100 patient years). There were no new deaths since the last report for the individual studies.
Most treatment-related AEs occurred within 12 months of the Optilume DCB procedure. No treatment-related SAEs have been reported after 1 year. 11 total non-serious treatment-related events were reported after 1 year. 5 in ROBUST I, 3 in ROBUST II, 2 in ROBUST III (Randomized), 1 in ROBUST III (Crossover) and none in the PK group. These AEs included: Dysuria (1.0%), Hematuria (0.5%), Lower urinary tract symptoms (0.5%), Nephrolithiasis (1.0%), Pollakiuria (0.5%), Renal calculi (0.5%), Urethral cancer (0.5%), Urethral meatus stenosis (0.5%), Urethral pain (0.5%), Urethral stenosis (5.7%), Urethral stricture (4.1%), urinary retention (3.1%), and Urine flow decrease (2.6%).These events were generally associated with stricture recurrence, for which investigators deemed them potentially related to the study device/procedure by way of failure to maintain efficacy and/or contribution to recurrence through repeated dilations similar to standard-of-care.
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| Final Effect Findings |
Responder Rate (Optilume pooled group)
(As Observed) 84% at 30-day follow-up and 81% at the 3-year follow-up (81 subjects reported).
(FCF) 52% at 3-year follow-up (66/126 subjects).
(LOCF) 60% at 3-year follow-up (115/191 subjects).
Freedom from Repeat Intervention
The Kaplan-Meier estimates of the proportion of subjects free from intervention through 3 years post-treatment was consistent between studies, with an overall estimate of 74.74% of subjects being free from reintervention through 3 years across the ROBUST clinical program. This compares to only 23.6% of subjects in the standard-of-care dilation Control arm in the ROBUST III study at 1-year post-treatment.
IPSS Over Time (Optilume pooled group)
(As Observed) 22.6 at baseline to 7.5 at the 3-year follow-up.
(FCF) 22.6 at baseline to 9.9 at the 3-year follow-up.
(LOCF) 22.6 to 9.8 at the 3-year follow-up.
Uroflowmetry - Peak Flow Rate (Qmax) (Optilume pooled group)
(As Observed) 7.2 at baseline to 13.7 at the 3-year follow-up.
(FCF) 7.2 at baseline to 12.1 at the 3-year follow-up.
(LOCF) 7.3 at baseline to 14.2 at the 3-year follow-up.
Uroflowmetry - Post-Void Residual Volume (PVR) (Optilume pooled group)
(As Observed) 133.8 at baseline to 72.7 at the 3-year follow-up.
(FCF) 133.8 at baseline to 84.5 at the 3-year follow-up.
(LOCF) 133.8 at baseline to 81.8 at the 3-year follow-up.
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