Presentation Authors: Sean Elliott*, Minneapolis, MN, Ramon Virasoro, Jessica DeLong, Virginia Beach, VA, Rafael Estrella, Miami, FL, Merycarla Pichardo, Merycarla Pichardo, Santo Domingo, Dominican Republic, Ramon Rodriguez, Panama City, Panama, Gustavo Espino, San Fernando, Spain, George Suarez, Miami, FL, George Webster, Durham, NC, Gerald Jordan, Virginia Beach, VA
Introduction: Introduction & Objective: Urethral strictures are most commonly treated via minimally invasive techniques such as dilation or direct vision internal urethrotomy (DVIU); but in men who have undergone more than 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 (Optilumeâ„¢ 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 Optilumeâ„¢ DCB.
Methods: Materials & Methods: Men with bulbar urethral strictures â‰¤ 2cm with 1-3 prior endoscopic treatments were enrolled at 4 study sites in the Dominican Republic and Panama following Ethics Committee approvals. The Optilumeâ„¢ DCB was inflated under cystoscopic visualization and placement confirmed via fluoroscopy. Subjects were evaluated at 2-5 days, 14-days, 3, 6- and 12-months post-treatment. Primary efficacy endpoint was improvement in IPSS and primary safety endpoint was serious complications through 3 months. Secondary endpoints included anatomic success, defined as the urethral lumen caliber â‰¥14F based on ability to pass a flexible cystoscope or a 14F catheter and change in uroflowmetry.
Results: Results: Fifty-three subjects were enrolled, and all successfully treated. Average subject age was 51 years (range 22-81). Stricture etiology was traumatic (51%), iatrogenic (45%) and idiopathic (4%). Average number of prior treatments was 1.25 per subject (range 1-4). Prior treatments included rigid dilation and DVIU, however most subjects were on a â€œdilation programâ€ or self-catheterization at home. Self-catheterizations were not counted in the number of prior treatments. There were no serious or unexpected device related adverse events.. Overall anatomic success rate at 12 months was 75% (35/47). The 12 failures were composed of 5 retreatments, 4 who failed the urethral lumen test; 3 exited the study for symptoms of recurrence without retreatment or failing the urethral lumen test and were considered failures. Mean IPSS decreased from 25.2Â±4.5 (baseline) to 4.9Â±5.6 (p < 0.001) in 42 men with 12-month data. Mean peak urinary flow (Qmax) increased from 5.0Â±2.6 ml/sec (baseline) to 19.5Â±9.9 (p < 0.001) ml/sec, again in 42 men at 12 months.
Conclusions: Conclusion: One-year data indicates the Optilumeâ„¢ DCB treatment is safe and the device produces urethra luminal gain that achieves significant clinical results with meaningful increased Qmax and decreased IPSS.
Source of Funding: Urotronic