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Starting soon Not applicable

Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

NCT06781606 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-01-17

Condition(s) studied

Adults with Traumatic Penile Severe DefectsCongenital Penile DefectsMicropenis

Investigational drug(s) / intervention(s)

Penile transplantation

Penile transplantation: The penile transplantation will take place at the Edouard Herriot hospital, part of the Hospices Civils de Lyon. It will be carried out on the same day or the day after the harvesting depending on the timing of the harvesting.

Study summary

Penile transplantation (PT) has recently emerged as an option for penile reconstruction and has shown encouraging outcomes at the international level with two ongoing PT program (US, South Africa). Emergence of such option has been possible thanks to the development of vascularized composite allotransplantation and because of the important limitations of autologous reconstruction (phalloplasty). Feasibility has already been proven, but the surgical management remains in its infancy and has never been tested at a European level. Furthermore, the balance between functional improvement and immunosuppressive risk still needs to be enlightened.

Eligibility

Sex
MALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Patient ≥ 18 years and ≤ 60 years * Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis) * ASA ≤ 2 * NYHA ≤ 1 * Creatinine clearance \> 60 mL/min (CKD-EPI) * Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up * Informed consent signed to participate to the study Exclusion Criteria: * Gender incongruence * Congenital penile defects resulting from exstrophy/epispadias * Penile malformation due to selh-half/self-amputation * Amputation for penile cancer * Other types of malignancy in remission for less than 5 years * Progressive malignant tumor * Presenting hepatitis B, hepatitis C, or HIV infection not controlled by appropriate anti-viral therapy * Uncontrolled arterial hypertension * Moderate renal failure : glomerular filtration rate of less than 60 mL/min per 1.73 m2 * EBV sero-negative recipient with EBV sero-positive graft, due to the risk of lymphoma * Non controlled chronic infection * Malignancy, Connective tissue disease * Amyloidosis * Unbalanced diabetes * Patient with a contraindication to performing an MRI examination * Contra-indication of Thymoglobuline: Hypersensitivity to rabbit proteins or to any of the excipients of Thymoglobuline, acute or chronic infections that contraindicate any additional immunosuppression, * Contra-inducation of tacrolimus: Hypersensitivity to tacrolimus or others macrolides, or any of the excipients of PROGRAF, * Contra-indication of Mycophenolate mofetil: in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients, Hypersensitivity reactions to mycophenolate mofetil; * History of major psychiatric disorders \< 3 years (psychotic disorders, severe substance abuse, severe personality disorders) or persons under psychiatric care ; * Person deprived of their liberty by a judicial or administrative decision ; * Person admitted to a health or social institution for purposes other than research * Adult subjects to a legal protection measure (guardianship, curatorship) * Person not affiliated to a social security scheme of beneficiaries of a similar scheme

Primary outcome measure(s)

  • Complete functional evaluation — 24 months
    Complete functional evaluation after penile transplantation, including the different function of the phallus : Urinary function (uroflowmetry, post-voiding residual voluma and Urinary Symptom Profile (USP®) );
  • Complete functional evaluation — 24 months
    Complete functional evaluation after penile transplantation, including the different function of the phallus : sexual function (penile doppler ultrasonography, nocturnal penile tumescence, Erection Hardness Score (EHS) and the International Index of Erectile Function (IIEF)).
  • Complete functional evaluation — 24 months
    Complete functional evaluation after penile transplantation, including the different function of the phallus : aesthetics and self-image (Rosenberg scale, Male Genital Self-image Scale (MGSIS), Self Esteem and Relationship questionnaire (SEAR))

Trial sites (9)

FacilityCityRegionStatus
Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux Bordeaux France
Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille Lille France
Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon Lyon France
Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception Marseille France
Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch Montpellier France
Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier Montpellier France
Service d'urologie Hôpital Lyon Sud Pierre-Bénite France
Service d'urologie Hôpital Foch Suresnes France
Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781606 on ClinicalTrials.gov ↗ ← All trials in France