PD45-05: Functional Improvement and Preservation of Sexual Function 3 Years After Treatment with the Optilume BPH Catheter System

Steven Kaplan*, New York, NY, Merycarla Pichardo, Santo Domingo, Dominican Republic, Edwin Rijo, La Romana, Dominican Republic, Ramon Rodriguez Lay, Gustavo Espino, Panama City, Panama, Rafael Estrella, Santiago de los Caballeros, Dominican Republic

Introduction: The EVEREST-I study is a prospective, single arm, multicenter study evaluating improvement in urinary function and maintenance of sexual function after treatment with the Optilume BPH System, a novel minimally-invasive treatment for lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH). Optilume BPH utilizes mechanical dilation of the prostatic urethra to achieve an anterior commissurotomy while delivering the drug paclitaxel to maintain urethral patency.

Methods: A total of 80 subjects were enrolled at 6 centers. Eligibility criteria have been previously published. Follow up is ongoing, with 38 of 75 expected subjects with 3-year follow-up complete. Symptom improvement was measured utilizing the International Prostate Symptom Score (IPSS), functional improvement measured by peak urinary flow rate (Qmax). Impact on sexual function was assessed by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).

Results: IPSS showed significant, immediate improvement from baseline with this improvement maintained through the 3 year follow-up (Table 1). IPSS quality of life scores were also significantly improved from baseline to 3 years (4.6 vs 2.2, p<0.001). Qmax increased from 10.9 mL/sec at baseline to 17.7 mL/sec at 3 years (p < 0.001). Erectile function, orgasmic function, and overall satisfaction with sexual function was maintained from baseline through 3 years as measured by the IIEF (Figure 1). Ejaculatory function and bother scores were not significantly changed from baseline through 3 years.

Conclusions: Treatment with Optilume BPH results in durable symptom improvement through 3 years post-treatment. Improvement in peak flow rate was achieved immediately post-treatment and was sustained through 3 years, indicating the increased cross-sectional area achieved via anterior commissurotomy during the procedure was maintained through long-term follow-up. Treatment did not impact sexual function.

Source of Funding: Urotronic sponsored and funded the EVEREST-I study.