Page 6 - CUA2019 Abstracts - BPH

Poster session 7: bPH, robotics, Infertility, sexual Dysfunction

Virginia Medical School, Virginia Beach, VA, United States; Department of traumatic (51%), iatrogenic (45%) and idiopathic (4%). Average num-
9
Urology, University of Minnesota, Minneapolis, MN, United States ber of prior treatments was 1.7 per subject (range 1-4). Prior treatments
Introduction: Urethral strictures are most commonly treated via minimally included rigid dilation and DVIU, however most subjects were on a
invasive techniques such as dilation or direct vision internal urethrotomy “dilation program” or self-catheterization at home. Self-catheterizations
(DVIU); but in men who have undergone more than 1 prior treatment, were not counted in the number of prior treatments. There were no serious
recurrence rates with repeat dilation or DVIU are over 50%, with an or unexpected device related adverse events. Overall anatomic success
average time to recurrence of 3 months[1]. A novel drug coated balloon rate at 12 months was 75% (35/47). The 12 failures were composed of 5
for urethral dilation (Optilume™ DCB) was designed to mechanically retreatments, 4 who failed the urethral lumen test; 3 exited the study for
dilate a stricture while delivering paclitaxel, an anti-proliferative drug symptoms of recurrence without retreatment or failing the urethral lumen
intended to reduce the rate of stricture recurrence. The ROBUST I study test and were considered failures. Mean IPSS decreased from 25.2±4.5
is a multi-center, prospective, non-randomized trial designed to determine (baseline) to 4.9±5.6 (p<0.001) in 42 men with 12-month data. Mean
the safety and efficacy of the Optilume™ DCB. peak urinary flow (Qmax) increased from 5.0±2.6 ml/sec (baseline) to
Methods: Men with bulbar urethral strictures ≤ 2cm with 1-3 prior endo- 19.5±9.9 (p<0.001) ml/sec, again in 42 men at 12 months.
scopic treatments were enrolled at 4 study sites in the Dominican Republic Conclusions: One-year data indicates the Optilume™ DCB treatment is
and Panama following Ethics Committee approvals. The Optilume™ DCB safe and the device produces urethra luminal gain that achieves significant
was inflated under cystoscopic visualization and placement confirmed clinical results with meaningful increased Qmax and decreased IPSS.
via fluoroscopy. Subjects were evaluated at 2-5 days, 14-days, 3, 6- and Reference
12-months post-treatment. Primary efficacy endpoint was improvement 1. Heyns CF, Steenkamp JW, de Kock ML, et al. Treatment of male
in IPSS and primary safety endpoint was serious complications through 3 urethral strictures: Is repeated dilation or internal urethrotomy
months. Secondary endpoints included anatomic success, defined as the useful? J Urol 1998;162:356-8. https://doi.org/10.1097/00005392-
urethral lumen caliber ≥14F based on ability to pass a flexible cystoscope 199808000-00016
or a 14F catheter and change in uroflowmetry.
Results: Fifty-three subjects were enrolled, and all successfully treated.
Average subject age was 51 years (range 22-81). Stricture etiology was

CUAJ • June 2019 • Volume 13, Issue 6(Suppl5) S135