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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
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.
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
Complete functional evaluation
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®) );
Time frame: 24 months
Complete functional evaluation
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)).
Time frame: 24 months
Complete functional evaluation
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))
Time frame: 24 months
Complete functional evaluation
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®) );
Time frame: Preoperatively, 6 months and 12 months
Complete functional evaluation
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))
Time frame: Preoperatively, 6 months and 12 months
Complete functional evaluation
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))
Time frame: Preoperatively, 6 months and 12 months
Postoperative complications
Any surgical complications which occur in the first three months post transplantation will be collected , they will be assessed according to their cause and level of severity (Clavien-Dindo Classification). Infectious and metabolic complications, side effects of immunosuppression including renal function, New Onset Diabetes After Transplantation (NODAT), infection, incidence of post-transplant malignancy will be collected throughout the study from blood tests and ECBU. Acute organ rejection evaluation will be evaluated by allograft biopsy (lymphocytic infiltrate, apoptosis, artery endothelialitis)
Time frame: up to 60 months
Qualitive evaluation
Semi-structured patient interviews will be performed. The preoperative interview will investigate the functional aspects of urination and sexuality when suffering from penile defect. A specific interest will be given to the expectations of the patient and foreseen benefit of PT. The appropriation and the experience of allotransplantation will be explored along with the different functionnal domains.
Time frame: Preoperatively, 6 months, 12 months and 24 months
Health-economic evaluation
The cost per penile transplantation procedure including transplant preparation will be estimated from the hospital perspective. Moreover the quantity of resources consumed and the total penile transplantation cost per patient including post-transplantation cost follow-up cost will be assessed from the health care system perspective.
Time frame: 24 months
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