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Long-term effects of combination treatment comprising low-intensity extracorporeal shockwave therapy and tadalafil for patients with erectile dysfunction: a retrospective study

Abstract

This study retrospectively examined the effects of low-intensity extracorporeal shockwave therapy and tadalafil on erectile dysfunction patients. 116 patients got low-intensity extracorporeal shockwave therapy twice weekly for 3 weeks, 5 mg of tadalafil daily for 3 weeks, and adjuvant therapy for 6 months. Group A (1 year), Group B (2 years), Group C (3 years), and Group D (4+ years) were treated patients’ follow-up groups. The patients’ International Index of Erectile Function-5 (IIEF-5) scores were gathered at the start of treatment via face-to-face interviews and at the end of follow-ups by telephone conversations. IIEF-5 scores and the minimal clinically significant differences were the main outcomes. Mean follow-up length, age, and IIEF-5 scores of the patients were 2 ± 1.16 years, 47.34 ± 12.65 years, and 12.09 ± 3.66 points, respectively. Compared to baseline, treatment increased the median IIEF-5 scores of patients in groups A, B, C, and D by 7 [3–12], 6 [0–8], 7 [1–9], and 6.5 [2.5–10] points, respectively (p = 0.001). 71%, 63%, 65.8%, and 65% of treated patients in groups A, B, C, and D met the minimal clinically significant differences criteria (n = 77). Mild disease patients were 9.14 times more likely to respond to treatment than severe illness patients (OR, 9.14; 95% CI, 1.28–65.46; P = 0.02). Low-intensity extracorporeal shockwave therapy and 5 mg of tadalafil can treat erectile dysfunction for up to 4 years with sustained outcomes. This treatment is optimal for mild illnesses.

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The data generated during this study can be found within the published article and its supplementary files. The additional data are available from the corresponding author upon reasonable request.

References

  1. Consensus NIH. Conference. Impotence. NIH consensus development panel on impotence. JAMA. 1993;270:83–90.

    Article  Google Scholar 

  2. Benet AE, Melman A. The epidemiology of erectile dysfunction. Urol Clin North Am. 1995;22:699–709.

    Article  CAS  PubMed  Google Scholar 

  3. Sullivan ME, Keoghane SR, Miller MA. Vascular risk factors and erectile dysfunction. BJU Int. 2001;87:838–45.

    Article  CAS  PubMed  Google Scholar 

  4. Salonia A, Castagna G, Saccà A, Ferrari M, Capitanio U, Castiglione F, et al. Is erectile dysfunction a reliable proxy of general male health status? The case for the international index of erectile function—erectile function domain. J Sex Med. 2012;9:2708–15.

    Article  PubMed  Google Scholar 

  5. Salonia A, Bettocchi C, Carvalho J, Corona G, Jones TH, Kadioglu A, et al. 2020 EAU guidelines on sexual and reproductive health. Arnhem: EAU Guidelines Office; 2020. https://uroweb.org/guideline/sexual-and-reproductive-health.

  6. Yuan J, Zhang R, Yang Z, Lee J, Liu Y, Tian J, et al. Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur Urol. 2013;63:902–12.

    Article  CAS  PubMed  Google Scholar 

  7. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N. Engl J Med. 1998;338:1397–404.

    Article  CAS  PubMed  Google Scholar 

  8. Porst H, Rosen R, Padma-Nathan H, Goldstein I, Giuliano F, Ulbrich E, et al. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res. 2001;13:192–9.

    Article  CAS  PubMed  Google Scholar 

  9. Brock GB, McMahon CG, Chen KK, Costigan T, Shen W, Watkins V, et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol. 2002;168:1332–6.

    Article  CAS  PubMed  Google Scholar 

  10. Porst H. The rationale for prostaglandin E1 in erectile failure: a survey of worldwide experience. J Urol. 1996;155:802–15.

    Article  CAS  PubMed  Google Scholar 

  11. Kohn TP, Rajanahally S, Hellstrom WJG, Hsieh TC, Raheem OA. Global trends in prevalence, treatments, and costs of penile prosthesis for erectile dysfunction in men. Eur Urol Focus. 2022;8:803–13.

    Article  PubMed  Google Scholar 

  12. Porst H, Giuliano F, Glina S, Ralph D, Casabé AR, Elion-Mboussa A, et al. Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial. Eur Urol. 2006;50:351–9.

    Article  CAS  PubMed  Google Scholar 

  13. Mulhall JP, Jahoda AE, Ahmed A, Parker M. Analysis of the consistency of intraurethral prostaglandin E(1) (MUSE) during at-home use. Urology. 2001;58:262–6.

    Article  CAS  PubMed  Google Scholar 

  14. Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010;58:243–8.

    Article  PubMed  Google Scholar 

  15. Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012;187:1769–75.

    Article  PubMed  Google Scholar 

  16. Aicher A, Heeschen C, Sasaki K, Urbich C, Zeiher AM, Dimmeler S. Low-energy shock wave for enhancing recruitment of endothelial progenitor cells: a new modality to increase efficacy of cell therapy in chronic hind limb ischemia. Circulation. 2006;114:2823–30.

    Article  PubMed  Google Scholar 

  17. Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of low-intensity extracorporeal shockwave therapy on erectile dysfunction: a systematic review and meta-analysis. J Sex Med. 2017;14:27–35.

    Article  PubMed  Google Scholar 

  18. Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity extracorporeal shock wave treatment improves erectile function: a systematic review and meta-analysis. Eur Urol. 2017;71:223–33.

    Article  PubMed  Google Scholar 

  19. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999;11:319–26.

    Article  CAS  PubMed  Google Scholar 

  20. Turunc T, Deveci S, Güvel S, Peşkircioğlu L. The assessment of Turkish validation with 5 question version of International Index of Erectile Function (IIEF-5). Turk J Urol. 2007;33:45–49.

    Google Scholar 

  21. Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011;60:1010–6.

    Article  PubMed  Google Scholar 

  22. Porst H, Buvat J, Meuleman E, Michal V, Wagner G. Intracavernous Alprostadil Alfadex—an effective and well tolerated treatment for erectile dysfunction. Results of a long-term European study. Int J Impot Res. 1998;10:225–31.

    Article  CAS  PubMed  Google Scholar 

  23. Zucchi A, Costantini E, Scroppo FI, Silvani M, Kopa Z, Illiano E, et al. The first-generation phosphodiesterase 5 inhibitors and their pharmacokinetic issue. Andrology. 2019;7:804–17.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Shah T, Wang R. A review of factors affecting patient satisfaction with inflatable penile prosthesis. Sex Med Rev. 2021;9:350–7.

    Article  PubMed  Google Scholar 

  25. Kitrey ND, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y, et al. Low intensity shock wave treatment for erectile dysfunction-how long does the effect last. J Urol. 2018;200:167–70.

    Article  PubMed  Google Scholar 

  26. Sokolakis I, Dimitriadis F, Teo P, Hatzichristodoulou G, Hatzichristou D, Giuliano F. The basic science behind low-intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic scoping review of pre-clinical studies. J Sex Med. 2019;16:168–94.

    Article  PubMed  Google Scholar 

  27. Gallo L, Pecoraro S, Sarnacchiaro P. Adjuvant daily therapy with L-arginine 2,500 mg and tadalafil 5 mg increases efficacy and duration of benefits of low-intensity extracorporeal shock wave therapy for erectile dysfunction: a prospective, randomized, single-blinded study with 1-year follow-up. Investig Clin Urol. 2022;63:83–91.

    Article  PubMed  Google Scholar 

  28. Verze P, Capece M, Creta M, La Rocca R, Persico F, Spirito L, et al. Efficacy and safety of low-intensity shockwave therapy plus tadalafil 5 mg once daily in men with type 2 diabetes mellitus and erectile dysfunction: a matched-pair comparison study. Asian J Androl. 2020;22:379–82.

    Article  CAS  PubMed  Google Scholar 

  29. Palmieri A, Arcaniolo D, Palumbo F, Verze P, Liguori G, Mondaini N, et al. Low intensity shockwave therapy in combination with phosphodiesterase-5 inhibitors is an effective and safe treatment option in patients with vasculogenic ED who are PDE5i non-responders: a multicenter single-arm clinical trial. Int J Impot Res. 2021;33:634–40.

    Article  CAS  PubMed  Google Scholar 

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Contributions

Yurdaer Kaynak designed the study and contributed to data extraction. The study was written by Yurdaer Kaynak. Ilan Gruenwald contributed to the writing of the paper and editing. Both of them approved the final version and submitted the paper to the journal.

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Correspondence to Yurdaer Kaynak or Ilan Gruenwald.

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The study was done under ethical approval (approval number: ESH/GOEK2022/1).

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Kaynak, Y., Gruenwald, I. Long-term effects of combination treatment comprising low-intensity extracorporeal shockwave therapy and tadalafil for patients with erectile dysfunction: a retrospective study. Int J Impot Res (2023). https://doi.org/10.1038/s41443-023-00757-7

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