Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

NCT06781606 | Not Yet Recruiting DMC

• 2 other identifiers: 69HCL22_09062024-A02180-47
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 9

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.

Conditions

Adults with Traumatic Penile Severe Defects; Congenital Penile Defects; Micropenis

Keywords

Penile transplatation; Vascularized Composite Allografts; Allotransplantation; En bloc harvesting; urinary function; sexual function; self-image

Outcome Measures

Primary Outcomes (3)

• 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®) );

  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)).

  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))

  24 months

Secondary Outcomes (6)

• Complete functional evaluation

  Preoperatively, 6 months and 12 months

• Complete functional evaluation

  Preoperatively, 6 months and 12 months

• Complete functional evaluation

  Preoperatively, 6 months and 12 months

• Postoperative complications

  up to 60 months

• Qualitive evaluation

  Preoperatively, 6 months, 12 months and 24 months

Study Arms (1)

Penile transplantation

EXPERIMENTAL

Procedure: Penile transplantation

Interventions

Penile transplantation PROCEDURE

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.

Penile transplantation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• French Association of Urology: collaborator

Study Sites (9)

Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux

Bordeaux, 33000, France

Location

Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille

Lille, 59037, France

Location

Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon

Lyon, 69003, France

Location

Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception

Marseille, 13005, France

Location

Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch

Montpellier, 34000, France

Location

Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier

Montpellier, 34295, France

Location

Service d'urologie Hôpital Lyon Sud

Pierre-Bénite, 69310, France

Location

Service d'urologie Hôpital Foch

Suresnes, 92151, France

Location

Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Penis agenesis

Interventions

Penile Transplantation

Intervention Hierarchy (Ancestors)

Vascularized Composite Allotransplantation; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Transplantation, Homologous

Study Officials

• Paul Neuville, Doctor

  Service d'urologie Hôpital Lyon Sud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Neuville, Doctor

CONTACT

+33 4 72 67 88 37; paul.neuville@chu-lyon.fr

Lionel Badet, Professor

CONTACT

+33 4 72 11 11 40; lionel.badet@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicentric, non-randomized, pilot study

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

FR (9)