Abstract
Urethral stricture diagnosis and treatments can have a significant impact on patients’ erectile function, ejaculatory function and sexual interest. The minimally invasive techniques such as direct visual internal urethrotomy (DVIU) and dilation have less impact on sexual function with poor long term outcomes that require retreatments. 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, including the impact of the Optilume DCB on erectile function using the International Index of Erectile Function (IIEF) questionnaire. 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 visualization and placement confirmed via fluoroscopy. Patients were evaluated at 2-5 days, 14-days, 3 and 6 months post-treatment. The IIEF questionnaire was collected at all follow-up visits. Pharmacokinetic (pK) testing was studied in a subset of subjects.
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