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The outcomes of inflatable penile prosthesis implantation in the context of Genital Gender Affirming Surgery in Assigned Female At Birth patients: A comparative study between cis-male Dacron modified and Zephyr Surgical Implants 475 Female To Male Penile Prosthesis

International Journal of Impotence Research (2025)Cite this article

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Abstract

The ideal device to be implanted into a neophallus has yet to be identified. Since 2016 Zephyr Surgical Implant 475 Female To Male (ZSI 475 FtM, Switzerland) series penile prosthesis (PP) have been proposed as “ad hoc” device. The aim of the study is to compare the outcomes of cis-male Dacron modified PP with ZSI 475 FTM PP. A single-center prospective study was performed between March 2011 and April 2024. Patients received either the implantation of a cis-male Dacron modified PP or ZSI 475 FTM PP. The primary endpoint was the comparison of the surgical outcomes. The secondary endpoint was the evaluation of device survival. 47 assigned female at birth (AFAB) patients were included in: 29 underwent a cis-male Dacron modified PP, 18 received ZSI 475 FTM PP. The median follow-up was 36 months (IQR 13–70). A significantly shorter operative time was observed in ZSI FTM PP group when compared to cis-male Dacron modified PP group (mean value of 85 (IQR 78–97) VS. 105 (IQR 89–150) minutes, p 0.001). No statistically significant differences were found regarding the rate of postoperative complications, although the cis-male Dacron-modified PP appeared to have a higher tendency for infection (24.1% vs. 5.6%) and mechanical failure (31% vs. 22.2%, p = 0.09 and p = 0.51, respectively) compared with the ZSI 475 FTM PP. Explantation free survival (EFS) at 12 months was higher in the ZSI 475 FTM PP group (100 VS. 79.3%, p-value 0.039). However, at 24 months, this advantage was lost (94.4% VS. 72.4%, p value 0.062). Both cis-male Dacron modified and ZSI 475 FTM PP may guarantee satisfactory surgical outcomes. High powered prospective trials are warranted to confirm the data.

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

References

  1. Prunas A, Mognetti M, Hartmann D, Bini M. La valutazione della disforia di genere: la versione italiana del gender identity/gender dysphoria questionnaire. Riv Sessuol Clin 2013)(American Psychiatric Association. Manuale Diagnostico e Statistico dei Disturbi Mentali, DSM-5-TR. Quinta Edizione-Text Revision. Raffaello Cortina Editore; 2023. 613–25 p.

  2. Arcelus J, Bouman WP, Van Den Noortgate W, Claes L, Witcomb G, Fernandez- Aranda F. Systematic review and meta-analysis of prevalence studies in transsexualism. Eur Psychiatry J Assoc Eur Psychiatr. 2015;30:807–15.

    Article  CAS  Google Scholar 

  3. Preto M, Blecher G, Timpano M, Gontero P, Falcone M. The Frontier of Penile Implants in Phalloplasty: Is the ZSI 475 FTM what we have been waiting for? Int J Impot Res. 2020;33:779–83. https://doi.org/10.1038/s41443-020-00396-2.

    Article  PubMed  Google Scholar 

  4. Schechter LS, Safa B. Introduction to Phalloplasty. Clin Plast Surg. 2018;45:387–9.

    Article  PubMed  Google Scholar 

  5. Chang TS, Hwang WY. Forearm flap in one-stage reconstruction of the penis. Plast Reconstr Surg. 1984;74:251–8.

    Article  PubMed  CAS  Google Scholar 

  6. Blasdel G, Zhao LC, Bluebond-Langner R. Surgical Gender Affirmation. In: Keuroghlian AS, Potter J, Reisner SL, curatori. Transgender and Gender Diverse Health Care: The Fenway Guide New York, NY: McGraw Hill; 2022.

  7. Al-Ali M, Al-Hajaj R. Johanson’s staged urethroplasty revisited in the salvage treatment of 68 complex urethral stricture patients: presentation of total urethroplasty. Eur Urol. 2001;39:268–71.

    Article  PubMed  CAS  Google Scholar 

  8. van de Grift TC, Pigot GLS, Kreukels BPC, Bouman MB, Mullender MG. Transmen’s experienced sexuality and genital gender-affirming surgery: Findings from a clinical follow-up study. J Sex Marital Ther. 2019;45:201–5.

    Article  PubMed  Google Scholar 

  9. Pigot GLS, Sigurjónsson H, Ronkes B, Al-Tamimi M, van der Sluis WB. Surgical Experience and Outcomes of Implantation of the ZSI 100 FtM Malleable Penile Implant in Transgender Men After Phalloplasty. J Sex Med. 2020;17:152–8. https://doi.org/10.1016/j.jsxm.2019.09.019.

    Article  PubMed  Google Scholar 

  10. Neuville P, Morel-Journel N, Maucourt-Boulch D, Ruffion A, Paparel P, Terrier JE. Surgical outcomes of erectile implants after phalloplasty: Retrospective analysis of 95 procedures. J Sex Med. 2016;13:1758–64.

    Article  PubMed  Google Scholar 

  11. Falcone M, Garaffa G, Gillo A, Dente D, Christopher AN, Ralph DJ. Outcomes of inflatable penile prosthesis insertion in 247 patients completing female to male gender reassignment surgery. BJU Int. 2018;121:139–44. https://doi.org/10.1111/bju.14027.

    Article  PubMed  CAS  Google Scholar 

  12. Kang A, Aizen JM, Cohen AJ, Bales GT, Pariser JJ. Techniques and considerations of prosthetic surgery after phalloplasty in the transgender male. Transl Androl Urol. 2019;8:273–82. https://doi.org/10.21037/tau.2019.06.02.

    Article  PubMed  PubMed Central  Google Scholar 

  13. van der Sluis WB, Pigot GLS, Al-Tamimi M, Ronkes BL, de Haseth KB, Özer M, et al. A retrospective cohort study on surgical outcomes of penile prosthesis implantation surgery in transgender men after phalloplasty. Urology. 2019;132:195–201.

    Article  PubMed  Google Scholar 

  14. Neuville P, Morel-Journel N, Cabelguenne D, Ruffion A, Paparel P, Terrier JE. First Outcomes of the ZSI 475 FtM, a specific prosthesis designed for phalloplasty. J Sex Med. 2019;16:316–22. https://doi.org/10.1016/j.jsxm.2018.11.013.

    Article  PubMed  Google Scholar 

  15. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: Development and validation. J Chronic Dis. 1987;40:373–83. https://doi.org/10.1016/0021-9681(87)90171-8

    Article  PubMed  CAS  Google Scholar 

  16. Falcone M, Timpano M, Oderda M, Cocci A, Morelli G, Preto M, et al. Suprapubic pedicled phalloplasty in transgender men: a multicentric retrospective cohort analysis. Int J Impot Res 2020;33:808–14. https://doi.org/10.1038/s41443-020-0238-4.

    Article  PubMed  Google Scholar 

  17. Falcone M, Garaffa G, Raheem A, Christopher NA, Ralph DJ. Total phallic reconstruction using the radial artery based forearm free flap after traumatic penile amputation. J Sex Med. 2016;13:1119–24. https://doi.org/10.1016/j.jsxm.2016.05.003.

    Article  PubMed  Google Scholar 

  18. Falcone M, Preto M, Timpano M, Ciclamini D, Crosio A, Giacalone F, et al. The surgical outcomes of radial artery forearm free-flap phalloplasty in transgender men: single-centre experience and systematic review of the current literature. Int J Impot Res. 2020;33:737–45. https://doi.org/10.1038/s41443-021-00414-x.

    Article  PubMed  Google Scholar 

  19. Felici N, Felici A. A new phalloplasty technique: the free anterolateral thigh flap phalloplasty. J Plast Reconstr Aesthet Surg. 2006;59:153–7. https://doi.org/10.1016/j.bjps.2005.05.016.

    Article  PubMed  CAS  Google Scholar 

  20. Carson CC 3rd, Mulcahy JJ, Harsch MR. Long-term infection outcomes after original antibiotic impregnated inflatable penile prosthesis implants: up to 7.7 years of followup. J Urol. 2011;185:614–8. https://doi.org/10.1016/j.juro.2010.09.094.

    Article  PubMed  Google Scholar 

  21. Mukherjee GD. Use of groin and mid-thigh flap in reconstruction of penis with penile and perineal urethra and a dorsal skin-lined socket for a removable prosthesis. Ann Plast Surg. 1986;16:235–41. https://doi.org/10.1097/00000637-198603000-00008.

    Article  PubMed  CAS  Google Scholar 

  22. Hoebeke PB, Decaestecker K, Beysens M, Opdenakker Y, Lumen N, Monstrey SM. Erectile implants in female-to-male transsexuals: our experience in 129 patients. Eur Urol. 2010;57:334–40. https://doi.org/10.1016/j.eururo.2009.03.013.

    Article  PubMed  Google Scholar 

  23. Verla W, Goedertier W, Lumen N, Spinoit AF, Waterloos M, Waterschoot M, et al. Implantation of the ZSI 475 FTM Erectile device after phalloplasty: a prospective analysis of surgical outcomes. J Sex Med. 2021;18:615–22. https://doi.org/10.1016/j.jsxm.2020.11.008.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Urology Clinic - A.O.U. “Città della Salute e della Scienza” – Molinette Hospital, University of Turin, Turin, Italy

    Marco Falcone, Federica Peretti, Mirko Preto, Lorenzo Cirigliano, Ilaria Ferro, Natalia Plamadeala, Martina Scavone, Emanuele Zupo & Paolo Gontero

  2. Neurourology Clinic - A.O.U. “Città della Salute e della Scienza” - Unità Spinale Unipolare, Turin, Italy

    Marco Falcone

  3. Urology dpt, Medical Faculty, Biruni University, Zeytinburnu, Istanbul, Turkey

    Marco Falcone

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  1. Marco Falcone
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Contributions

MF had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: FP, MF, LC, PG. Acquisition of data: FP, MP, IF, NP, MS, EZ. Analysis and interpretation of data: FP, LC, MF. Drafting of the manuscript: FP, LC. Critical revision of the manuscript for important intellectual content: MF, PG,MP. Statistical analysis: LC, MF. Obtaining funding: None. Administrative, technical, or material support: None. Supervision: PG. Other: None.

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Correspondence to Marco Falcone.

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Competing interests

Marco Falcone certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g., employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Falcone is members of EAU Sexual and Reproductive Health Guideline Panel. All other authors declare no conflict of interest.

Ethical approval

The study was approved by the local ethics committee (Protocol No: 0036656). Prior to study participation, all patients signed an informed consent form. All procedures were performed in accordance with the ethical standards reported in the Declaration of Helsinki.

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Ethical approval

the study was approved by the local ethics committee (Protocol No: 0036656). Prior to study participation, all patients signed an informed consent form. All procedures were performed in accordance with the ethical standards reported in the Declaration of Helsinki.

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Falcone, M., Peretti, F., Preto, M. et al. The outcomes of inflatable penile prosthesis implantation in the context of Genital Gender Affirming Surgery in Assigned Female At Birth patients: A comparative study between cis-male Dacron modified and Zephyr Surgical Implants 475 Female To Male Penile Prosthesis. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01137-z

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