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Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment

  • Dimitrios Kalyvianakis
    Affiliations
    Department of Urology, University of Crete, Heraklion, Greece

    1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Institute for the Study of Urological Diseases, Thessaloniki, Greece
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  • Evangelos Memmos
    Affiliations
    1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Institute for the Study of Urological Diseases, Thessaloniki, Greece
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  • Ioannis Mykoniatis
    Correspondence
    Corresponding Author: Ioannis Mykoniatis, MD, MSc, 1st Department of Urology, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece. Tel: 302310992542; Fax: 302310992543
    Affiliations
    1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Institute for the Study of Urological Diseases, Thessaloniki, Greece
    Search for articles by this author
  • Paraskevi Kapoteli
    Affiliations
    1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Institute for the Study of Urological Diseases, Thessaloniki, Greece
    Search for articles by this author
  • Dimitrios Memmos
    Affiliations
    1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Institute for the Study of Urological Diseases, Thessaloniki, Greece
    Search for articles by this author
  • Dimitrios Hatzichristou
    Affiliations
    1st Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece

    Institute for the Study of Urological Diseases, Thessaloniki, Greece
    Search for articles by this author
Published:February 03, 2018DOI:https://doi.org/10.1016/j.jsxm.2018.01.003

      Abstract

      Background

      There is lack of evidence-based optimization of the protocol for low-intensity shockwave therapy for erectile dysfunction. Furthermore, the safety and efficacy of repeating shockwave therapy have not been explored.

      Aim

      To compare the efficacy and safety of 6 and 12 treatment sessions within a 6-week treatment period and investigate the effect of repeat treatment after a 6-month period in a 2-phase study.

      Methods

      Patients with vasculogenic erectile dysfunction that responded to phosphodiesterase type 5 inhibitors were randomized into 2 groups: low-intensity shockwave therapy sessions once (group A, n = 21) or twice (group B, n = 21) per week for 6 consecutive weeks (phase 1). Patients who completed 6-month follow-up were offered 6 additional sessions (phase 2); group A received 2 sessions per week and group B received 1 session per week. Patients were followed for 6 months.

      Outcomes

      International Index for Erectile Function erectile function domain (IIEF-EF) score, minimally clinical important differences (MCIDs), Sexual Encounter Profile question 3 (SEP3) score, and triplex ultrasonographic parameters.

      Results

      In phase 1, groups A and B showed improvement in IIEF-EF score, MCID, SEP3 score, and mean peak systolic velocity compared with baseline. MCIDs were achieved in 62% of group A and 71% of group B, and the percentage of yes responses to SEP3 was 47% in group A and 65% in group B (P = .02). Mean peak systolic velocity at baseline and at 3-month follow-up were 29.5 and 33.4 cm/s for group A and 29.6 and 35.4 cm/s for group B (P = .06). In phase 2, group A showed a greater increase in the percentage of yes responses to SEP3 (group A = +14.9; group B = +0.3). When the impact of the total number of sessions received was examined, MCIDs in IIEF-EF score from baseline were achieved in 62%, 74%, and 83% of patients after 6, 12, and 18 sessions, respectively. No treatment-related side effects were reported.

      Clinical Implications

      The total number of low-intensity shockwave therapy sessions affects the efficacy of erectile dysfunction treatment. Retreating patients after 6 months could further improve erectile function without side effects. 12 sessions can be delivered within 6 weeks without a 3-week break period.

      Strengths and Limitations

      This study lacked a sham-controlled arm. However, all patients were randomized to different groups, and baseline characteristics were similar between groups. Also, all patients were confirmed by triplex ultrasonography to have arterial insufficiency.

      Conclusion

      Patients can benefit more in sexual performance from 12 sessions twice per week compared with 6 sessions once a week. Shockwave therapy can be repeated up to a total of 18 sessions.
      Kalyvianakis D, Memmos E, Mykoniatis I, et al. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med 2018;15:334–345.

      Key Words

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