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Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use

International Journal of Impotence Research volume 35, pages 378–384 (2023)Cite this article

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Abstract

A eutectic mixture of prilocaine/lidocaine spray (Fortacin™, Recordati, Milan, Italy) has been approved for the management of patients affected by life-long premature ejaculation (PE), but to date, there is a lack of dose- or time-finding studies in the literature that indicate the best method of intake to optimize treatment outcomes. In this multicentre, randomized, two-phase study, we aimed to compare, in terms of treatment effectiveness (primary objective) and safety (secondary objective), different treatment regimens (various doses and times of drug delivery) of Fortacin™ in 91 patients affected with lifelong PE who were recruited at four different centres and randomized (1:1:1 ratio) into three different groups. The study included two phases: during the first phase (focused on time-finding), the same drug dose (three sprays) was taken at different intervals before intercourse (5, 15, 30 min). In the second phase (focused on dose finding), different drug doses (1, 3, 5 sprays) were taken at the same interval before intercourse (5 min). The main outcome measure instruments were self-measured intravaginal ejaculation latency time (sm-IELT), the premature ejaculation diagnostic tool (PEDT), and the International Index of Erectile Function-5 (IIEF-5). Furthermore, patients were asked to report any side effects that appeared during the study period. Our main study findings showed that the treatment regimen with three sprays of Fortacin™ administered 5 min before sexual intercourse showed the best results in terms of ejaculation time and control (Phase I, IELT 221 ± 3.4, PEDT 7.7 ± 0.3; Phase II, IELT 213 ± 4.9, PEDT 7.8 ± 0.4) with a safety profile that was identical to other treatment regimens. Based on these data, patients who are prescribed Fortacin™ should stick to this regimen to optimize treatment results.

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Data availability

The datasets generated during and analyzed during the current study are not publicly available due to privacy regulation in the Italian bylaw but are available from the corresponding author on reasonable request to the Italian regulatory Authorities.

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Acknowledgements

We are grateful to all the secretary staff members of the Italian Society of Andrology (SIA) for their fruitful support in data collection and analysis.

Funding

The Recordati Company supported the Italian Society of Andrology (SIA) in conducting the study and coordinating all scientific activities with a research grant.

Author information

Authors and Affiliations

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

    Tommaso Cai

  2. Institute of Clinical Medicine, University of Oslo, Oslo, Norway

    Tommaso Cai

  3. Department of Health Sciences, University of Catanzaro, Catanzaro, Italy

    Luca Gallelli

  4. Clinical Pharmacology and Pharmacovigilance Unit, Mater Domini Hospital, Catanzaro, Italy

    Luca Gallelli

  5. Department of Medicine, Surgery, Dentistry “Scuola Medica Salernitana”, —University of Salerno, Baronissi, Italy

    Paolo Verze

  6. Division of Experimental Oncology/Unit of Urology, URI; IRCCS Ospedale San Raffaele, Milan, Italy

    Andrea Salonia

  7. University Vita-Salute San Raffaele, Milan, Italy

    Andrea Salonia

  8. Department of Urology, University of Naples, Federico II, Naples, Italy

    Alessandro Palmieri

Authors
  1. Tommaso Cai
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  2. Luca Gallelli
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  3. Paolo Verze
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  4. Andrea Salonia
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  5. Alessandro Palmieri
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Contributions

TC and LG: data collection and analysis; TC, LG, and PV: paper writing; AS and AP: supervision.

Corresponding author

Correspondence to Tommaso Cai.

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Competing interests

TC, PV, AS, and AP received research and speaker grants from the Recordati Company.

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Cai, T., Gallelli, L., Verze, P. et al. Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use. Int J Impot Res 35, 378–384 (2023). https://doi.org/10.1038/s41443-022-00554-8

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