PD22-06 ONE-YEAR SAFETY AND EFFICACY OUTCOMES ON A NOVEL DRUG COATED BALLOON (DCB) FOR URETHRAL STRICTURE DISEASE - THE ROBUST I STUDY

Abstract

INTRODUCTION AND OBJECTIVES: 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 (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: Materials & Methods: Men with bulbar urethral strictures ≤ 2cm with 1-3 prior endoscopic treatments were enrolled at 4 study sites in the Dominican Republic and Panama following Ethics Committee approvals. The Optilume™ 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 ≥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 “dilation program” 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 25.2±4.5 (baseline) to 4.9±5.6 (p<0.001) in 42 men with 12-month data. Mean peak urinary flow (Qmax) increased from 5.0±2.6 ml/sec (baseline) to 19.5±9.9 (p<0.001) ml/sec, again in 42 men at 12 months. CONCLUSIONS: One-year data indicates the Optilume™ 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