New Technology: Miscellaneous

Moderated Poster Session

MP22-12 - Initial safety and efficacy outcomes of a novel drug-coated balloon (DCB) for treatment-refractory urethral stricture disease – The ROBUST I Study

Saturday, September 22
2:00 PM - 4:00 PM
Location: Room 252B

Introduction & Objective : Urethral strictures are most commonly treated via minimally invasive techniques such as dilation or direct visual internal urethrotomy (DVIU); but in men who have undergone >=1 prior treatment, recurrence rates with repeat dilation or DVIU are over 50%, with an average time to recurrence of 3 months. A novel drug-coated balloon for urethral dilation (Optilume™ DCB) was designed to mechanically dilate a stricture while delivering paclitaxel, an anti-proliferative drug intended to reduce the rate of stricture recurrence. The ROBUST I study is a multi-center, prospective, non-randomized trial designed to determine the safety and efficacy of the Optilume DCB.

 


Methods : Men with bulbar urethral stricture ≤2cm with 1-3 prior treatments were enrolled at 4 study sites in the Dominican Republic and Panama. The Optilume DCB was inflated under cystoscopic vision and placement confirmed by fluoroscopy. Patients were evaluated at 2-5 days, 14-days, 3 and 6 months post-treatment. Primary outcome was anatomic success at 6 months, defined as > 14F based on ability to pass a cystoscope or a 14F catheter. Secondary outcomes included International Prostate Symptom Score (IPSS) and uroflowmetry. Pharmacokinetic (pK) testing was studied in a subset of subjects. Pharmacokinetic test results confirmed a small amount of paclitaxel present in the urine immediately post procedure that was almost cleared by day 5 and no paclitaxel detectable (limit of quantification 0.100 ng/mL) in the blood plasma 1 hr post procedure. Semen quality was assessed (Count, motility, progressive motility, morphology, and Vitality) at days 14 and 6 months post procedure.  No changes observed in any category compared to pre-procedure samples


Results :

53 subjects were enrolled and all were successfully treated. Average patient age was 51 years (range 22-81). All have minimum 6 months of follow-up. Stricture etiology was traumatic (51%), iatrogenic (45%) or idiopathic (4%). There were no serious or unexpected adverse events (AEs). Mean IPSS decreased from 25.2±4.5 (baseline) to 4.8±6.4 (p<0.001) at 6 months. Mean peak urinary flow (Qmax) increased from 5.0±2.6 ml/sec (baseline) to 20.5±10.4 (p< 0.001) ml/sec at 6 months. Anatomic success rate at 6 months was 73.2%. Pk test results confirmed the amount of paclitaxel present in blood plasma or semen following treatment to be Below Lower Limit of Quantitation. Drug concentration in the urine was highest immediately post-procedure and dropped significantly by day 5.


Conclusions :

Initial data indicates the Optilume DCB treatment is safe and the device performs as intended with promising results at a short term follow up. 

Ramón Virasoro

Associate Professor
Eastern Virginia Medical School

Dr. Ramón Virasoro earned his medical degree from the University of Buenos Aires, Argentina, in 1991. He completed both general surgery and urology residencies at Centro de Educación Médica e Investigaciones Clínicas (CEMIC) in Buenos Aires, Argentina from 1992 to 1999. He practiced general urology from 2000-2004 at CEMIC, where he was a member of the kidney transplant team.
Dr. Virasoro completed his fellowship in Adult and Pediatric Genitourinary Reconstructive Surgery in 2007, in Norfolk, VA.
Back in Argentina, he developed the genitourinary reconstructive surgery section at CEMIC. He was the coordinator until he joined Urology of Virginia, in 2011.
Dr. Virasoro is a member of the American Urological Association, and served as the Argentine representative for the International Members Committee of the AUA from 2008 to 2011. He is also an active member of the Society of Genitourinary Reconstructive Surgeons (GURS), and The Société Internationale d’Urologie (SIU).
Dr. Virasoro is a board member of GURS and Board memeber and International Medical Educator (IME) with Physicians for Peace, a local non-profit organization. Since 2013, he has completed bi-annual humanitarian missions to the Dominican Republic (DR), where he performs reconstructive surgeries for indigent patients.
Dr. Virasoro is the Co-Founder, and Co-Director of a Genitourinary Reconstructive Surgery Fellowship in Santo Domingo, DR. The fellowship, accredited by Universidad Autónoma de Santo Domingo, est. 1538, will train three local Urologists over the next 5 years.
Dr. Virasoro has published several articles regarding genitourinary reconstruction, and has authored many chapters in urology. He has presented his research at numerous national and international meetings.
When not working, Dr. Virasoro enjoys time with his family.

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    Jessica DeLong

    Assistant Professor
    Eastern Virginia Medical School

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      Rafael Estrella

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        Merycarla Pichardo

        Associate
        URUS

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          Ramon Rodriguez Lay

          Attending Urologist
          Cirujano Urólogo Royal Center Panama City, Panama

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            Gustavo Espino

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              George M. Suarez

              Professor of Urology
              Jackson Memorial Hospital, South.

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                Sean Elliot

                Professor
                University of Minnesota

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                  MP22-12 - Initial safety and efficacy outcomes of a novel drug-coated balloon (DCB) for treatment-refractory urethral stricture disease – The ROBUST I Study



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