The journal of sexual medicine · 2025
Preservation of sexual function with Optilume-a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Copelan Olivia, Moss Jared, Freedman Sheldon, Coutinho Karl, Elterman Dean, Marotte Jeffrey, Padron Osvaldo, Shore Neal, Spier Jeffrey, Kaminetsky Jed, Mazzarella Brian, Te Alexis, Kaplan Steven A, McVary Kevin T
Аннотация
BACKGROUND: The Optilume benign prostatic hyperplasia (BPH) catheter system is a novel minimally invasive paclitaxel-coated dilation system that has demonstrated substantial and durable results in urinary flow and symptoms.
AIM: We now assess the impact of Optilume BPH procedure on sexual function.
METHODS: Prior published results have described the methods of data collection during the PINNACLE study, which demonstrated durable improvement in urinary symptoms. Follow-up assessments for the current study included IIEF-EF and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Semen quality was also examined.
OUTCOMES: IIEF-EF and MSHQ-EjD scores in the Optilume BPH group were not different from the sham group at 3 months, 6 months, or 12 months.
RESULTS: A total of 148 men were randomized to receive the procedure (100) or a sham surgical procedure (48). Subjects in both groups had similar rates of erectile dysfunction (ED) previously diagnosed at baseline (56% vs 54.2%, P = .83) and those men who were sexually active. IIEF-EF and MSHQ-EjD scores in the Optilume BPH group were not different from the sham group at 3, 6, or 12 months. Change in IIEF-EF scores remained consistent across all levels of baseline ED severity after Optilume BPH procedure. No clear trend was seen after treatment with Optilume BPH for semen volume, sperm motility, progressive motility, or sperm morphology.
CLINICAL IMPLICATIONS: The Optilume BPH catheter system provides patients with a durable improvement in lower urinary tract symptoms while preserving sexual function.
STRENGTHS AND LIMITATIONS: This study uses validated questionnaires to assess patients' sexual function at baseline and regularly for 1 year after the procedure. Given exclusion criteria regarding patient age and prostate size, the results may not be applicable to all BPH phenotypes.
CONCLUSION: Optilume appears to provide clinical benefit with a high degree of patient satisfaction and minimal impact on sexual function.
AIM: We now assess the impact of Optilume BPH procedure on sexual function.
METHODS: Prior published results have described the methods of data collection during the PINNACLE study, which demonstrated durable improvement in urinary symptoms. Follow-up assessments for the current study included IIEF-EF and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). Semen quality was also examined.
OUTCOMES: IIEF-EF and MSHQ-EjD scores in the Optilume BPH group were not different from the sham group at 3 months, 6 months, or 12 months.
RESULTS: A total of 148 men were randomized to receive the procedure (100) or a sham surgical procedure (48). Subjects in both groups had similar rates of erectile dysfunction (ED) previously diagnosed at baseline (56% vs 54.2%, P = .83) and those men who were sexually active. IIEF-EF and MSHQ-EjD scores in the Optilume BPH group were not different from the sham group at 3, 6, or 12 months. Change in IIEF-EF scores remained consistent across all levels of baseline ED severity after Optilume BPH procedure. No clear trend was seen after treatment with Optilume BPH for semen volume, sperm motility, progressive motility, or sperm morphology.
CLINICAL IMPLICATIONS: The Optilume BPH catheter system provides patients with a durable improvement in lower urinary tract symptoms while preserving sexual function.
STRENGTHS AND LIMITATIONS: This study uses validated questionnaires to assess patients' sexual function at baseline and regularly for 1 year after the procedure. Given exclusion criteria regarding patient age and prostate size, the results may not be applicable to all BPH phenotypes.
CONCLUSION: Optilume appears to provide clinical benefit with a high degree of patient satisfaction and minimal impact on sexual function.