Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

Not Applicable

Not yet recruiting

• Conditions: Adults with Traumatic Penile Severe Defects; Congenital Penile Defects; Micropenis

• Registration Number: NCT06781606
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-06-01
• Primary Completion: 2030-06-01
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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))

Secondary Outcome Measures

Name	Time	Method
Complete functional evaluation	Preoperatively, 6 months and 12 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))
Postoperative complications	up to 60 months	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)
Qualitive evaluation	Preoperatively, 6 months, 12 months and 24 months	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.
Health-economic evaluation	24 months	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.

Trial Locations

Locations (9)

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