Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Hospices Civils de Lyon trials in France
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