(122) Preservation of Sexual Function: 12-month Outcomes from a Randomized, Double-Blind, Sham Controlled Study Evaluating the Optilume BPH System, a Novel Drug Coated Balloon

Abstract Introduction Many front-line treatments for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), such as medications and transurethral resection of the prostate, have well established negative effects on sexual function. New minimally invasive surgical therapy (MIST) for LUTS/BPH need to preserve sexual function to meet the needs of men. Data from the randomized controlled blinded study of the Optilume BPH System was analyzed to evaluate the sexual side effects of this novel treatment. Objective The PINNACLE study is a prospective, randomized, double-blind, sham controlled study evaluating the Optilume BPH System. Optilume BPH is a novel MIST that combines mechanical dilation with delivery of paclitaxel for treatment of LUTS/BPH. The mechanical dilation with Optilume BPH achieves an anterior commissurotomy, while delivery of paclitaxel is intended to maintain luminal patency during healing, while preserving sexual function. Methods 148 subjects with symptomatic LUTS/BPH and a prostate size between 20-80 grams were randomized in a 2:1 fashion (Optilume to Sham) at 18 centers in the US and Canada. Follow-up is complete through 12-months. To evaluate the effect of the treatment on sexual function, the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire to assess Ejaculatory Dysfunction (MSHQ-EjD) questionnaires were used. Questionnaires were administered at baseline and 3, 6, and 12-months post procedure, regardless of sexual activity at baseline. A sub-set of 15 non-randomized subjects treated with Optilume BPH underwent further testing for semen quality and measurement of the amount of paclitaxel found in semen post-treatment. Results The average IIEF-EF score at baseline was 15-16 for both arms, mild to moderate erectile dysfunction (Figure 1). Scores across all domains improved slightly from baseline through 12 months, indicating that treatment with the Optilume BPH device had no significant impact on perceived sexual function. This finding is consistent when looking at men who were sexually active at baseline (Figure 2). Ejaculatory function also showed slight improvement from baseline to 12 months in both the overall population and the subset of men who were sexually active at baseline (Figure 1, Figure 2). There is no appreciable change in ejaculation bother from baseline to 12-months in the overall population and the sexually active subset (Figure 1, Figure 2). Overall semen quality parameters did not change post-procedure (Table 1). A slight decrease in sperm concentration was noted post-treatment, although this decrease was not significant at the 3- and 6-month timepoints. Paclitaxel was detected in semen in the majority of subjects tested at 30 days and 3 months post-procedure. The paclitaxel concentration in semen steadily decreased over time, nearing the limit of quantitation of the method by 6 months post-procedure. Conclusions Treatment with Optilume BPH preserved erectile and ejaculatory function. IIEF and MSHQ-EjD scores were not different from control at any time point. New MISTs for LUTS/BPH need to preserve sexual function to meet the needs of men and Optilume appears to meet this objective. Disclosure Yes, this is sponsored by industry/sponsor: Urotronic. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Urotronic.

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