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Bedtime sildenafil oral suspension improves sexual spontaneity and time-concerns compared to on-demand treatment in men with erectile dysfunction: results from a real-life, cross-sectional study

International Journal of Impotence Research (2025)Cite this article

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Abstract

Phosphodiesterase type 5 inhibitors (PDE5i) are among the first line treatment options in men with erectile dysfunction (ED). On-demand sildenafil has proved to be an effective PDE5i but with lower spontaneity scores compared to daily tadalafil treatment. We aimed to investigate the impact of on-demand sildenafil compared to bedtime use on efficacy and spontaneity scores in men with ED. We retrospectively analysed data from a cohort of men with mild/moderate ED treated for three months with on-demand sildenafil 50 mg oral suspension formulation (OSF) (group 1, n = 40), bedtime sildenafil 50 mg OSF (group 2, n = 40) and bedtime sildenafil 37.5 mg OSF (group 3, n = 40). After three months patients were evaluated with the International Index of Erectile Function-5 items (IIEF-5) and the Psychological and Interpersonal Relationship Scales-Short Form (PAIRS-SF) questionnaires. Propensity score matching was used to adjust for baseline confounders. The IIEF-5 and PAIRS-SF scores were compared between groups at follow-up with the repeated measures ANOVA test. Linear regression analyses tested the associations between study variables and spontaneity scores. After matching, median patient’s age and ED duration were 56 (50–61) years and 18 (10–20) months, respectively. Compared to baseline, IIEF-5 scores significantly improved after sildenafil OSF treatment, irrespective of the therapeutic approach (all p < 0.01 vs. baseline). The PAIRS-SF spontaneity score was significantly better in group 2 [15 (13–16), p < 0.01] and group 3 [14 (14–16), p < 0.01] compared to the on-demand use [13 (12–13)]. Fewer time concerns were reported for bedtime use than on-demand sildenafil. Sildenafil OSF bedtime use was found to be an independent predictor for better spontaneity and fewer time concerns scores (all p < 0.001). Bedtime sildenafil OSF showed similar efficacy but better spontaneity scores than on-demand use. Bedtime sildenafil is a valuable option for men with ED prioritizing efficacy and sexual spontaneity.

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Author information

Authors and Affiliations

  1. Department of Urology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy

    Luca Boeri

  2. Urology Unit, Di Venere Hospital, 70100, Bari, Italy

    Fabrizio Palumbo

  3. Department of Urology, Santa Chiara Regional and Teaching Hospital, 38123, Trento, Italy

    Tommaso Cai

  4. Department of Urology, University of Bari, 70100, Bari, Italy

    Carlos Miacola

  5. Department of Urology, University of Turin, Le Molinette Hospital, 10024, Turin, Italy

    Carlo Ceruti

  6. Urology Unit, ASL Roma 2, Sandro Pertini Hospital, 00100, Rome, Italy

    Marco Bitelli

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

    Danilo Di Trapani

  8. Department of Urology, University of Trieste, Cattinara Hospital-ASUGI, Trieste, Italy

    Andrea Piasentin

  9. Andrology Unit, CEMS, 37100, Verona, Italy

    Giorgio Piubello

  10. Department of Urology, Asti Hospital, Asti, Italy

    Chiara Polito

  11. Urology Unit, Department of Woman Child and of General and Specialist Surgery, University of Campania “Luigi Vanvitelli”, 80138, Naples, Italy

    Davide Arcaniolo

  12. Department of Urology, University of Naples, Federico II, 80013, Naples, Italy

    Marco Magliocchetti & Alessandro Palmieri

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Contributions

LB wrote the paper, FP, TC, CM, CC, MB, DDT, AP, GP, CP, MM, DA collected data; FP, TC and AP supervised the paper, approved the final version of the manuscript.

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Correspondence to Luca Boeri.

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All methods were performed in accordance with the relevant guidelines and regulations; all patients signed an informed consent agreeing to share their own anonymous information for other future studies. The study was approved by the Hospital Ethical Committee (Prot. 060194).

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Boeri, L., Palumbo, F., Cai, T. et al. Bedtime sildenafil oral suspension improves sexual spontaneity and time-concerns compared to on-demand treatment in men with erectile dysfunction: results from a real-life, cross-sectional study. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01035-4

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