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The intra-meatal application of alprostadil cream (Vitaros®) improves drug efficacy and patient’s satisfaction: results from a randomized, two-administration route, cross-over clinical trial

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Abstract

To investigate the efficacy, tolerability, and patient’s preference of alprostadil cream for topical use administered within the urethral meatus versus the standard administration route, in erectile dysfunction (ED) treatment. Seventy-one patients (mean age 59.7 ± 9.0 years) affected by ED were analyzed in this multicenter, randomized, two-administration routes, cross-over trial. All patients received a single dose of alprostadil cream applying the dispenser to the tip of the penis (without contacting the urethral meatus) (Standard administration route or ST.AR) alternating with a single dose of alprostadil cream applying the dispenser within the urethral meatus (New administration route or NEW.AR) separated by a one-week washout period, according to randomization. The primary objective of the study was to evaluate the change in International Index of Erectile Function (IIEF-5) total score from baseline to the control visit by comparing the ST.AR and NEW.AR. Secondary objectives of the study were to compare the different methods of administration by evaluating the change in the Sexual Encounter Profile (SEP-2 and SEP-3) questionnaire score and the Patient Reported Outcomes (PROs) by scoring the Patient Self-Assessment of Erection (PSAE) questionnaire. The treatment safety profile was assessed by analysis of adverse events (AEs). Based on the study findings it is evident that the NEW.AR is more efficacious than the ST.AR in improving IIEF-5 and SEP scores from baseline to control visit (IIEF-5: +3.8 vs +6.3; p < 0.001; positive response to SEP-2: 10 vs 27; p = 0.002) and in terms of PSAE (a significant improvement from the baseline in 31% of patients; p < 0.001). As regards the safety profile, no difference in terms of local and systemic side effects was found.

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Authors and Affiliations

  1. Department of Urology, Santa Chiara Regional Hospital, Trento, Italy

    Tommaso Cai

  2. San Giacomo Hospital, Monopoli, BA, Italy

    Fabrizio Palumbo

  3. Department of Urology, University of Trieste, Trieste, Italy

    Giovanni Liguori

  4. Urology Unit, Nuovo San Giovanni di Dio Hospital, Florence, Italy

    Nicola Mondaini

  5. Urology Unit, Ospedale di Circolo di Varese, Varese, Italy

    Fabrizio Idelfonso Scroppo

  6. Urology Unit, Buccheri La Ferla Fatebenefratelli Hospital, Palermo, Italy

    Danilo Di Trapani

  7. Department of Urology, University of Florence, Florence, Italy

    Andrea Cocci

  8. Department of Urology, University of Perugia, Perugia, Italy

    Alessandro Zucchi

  9. Department of Neurosciences, Reproductive Sciences, Odontostomatology - Urology Unit, University of Naples “Federico II”, Naples, Italy

    Paolo Verze & Alessandro Palmieri

  10. Department of Urology, University Vita e Salute, San Raffaele, Milan, Italy

    Andrea Salonia

Authors
  1. Tommaso Cai
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  2. Fabrizio Palumbo
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  3. Giovanni Liguori
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  4. Nicola Mondaini
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  5. Fabrizio Idelfonso Scroppo
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  6. Danilo Di Trapani
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  7. Andrea Cocci
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  8. Alessandro Zucchi
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  9. Paolo Verze
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  10. Andrea Salonia
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  11. Alessandro Palmieri
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Correspondence to Paolo Verze.

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Cai, T., Palumbo, F., Liguori, G. et al. The intra-meatal application of alprostadil cream (Vitaros®) improves drug efficacy and patient’s satisfaction: results from a randomized, two-administration route, cross-over clinical trial. Int J Impot Res 31, 119–125 (2019). https://doi.org/10.1038/s41443-018-0087-6

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  • DOI: https://doi.org/10.1038/s41443-018-0087-6

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