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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02180-47 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| French Association of Urology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penile transplantation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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®) ); | Preoperatively, 6 months and 12 months |
| Complete functional evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Paul Neuville, Doctor | Service d'urologie Hôpital Lyon Sud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Tripode CHU Bordeaux | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| C536649 | Penis agenesis |
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| ID | Term |
|---|---|
| D000093667 | Penile Transplantation |
| ID | Term |
|---|---|
| D063986 | Vascularized Composite Allotransplantation |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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Prospective, multicentric, non-randomized, pilot study
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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)) |
| 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)) | 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) | 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. | 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. | 24 months |
| Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille | Lille | 59037 | France |
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| Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civils de Lyon | Lyon | 69003 | France |
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| Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception | Marseille | 13005 | France |
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| Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Saint Roch | Montpellier | 34000 | France |
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| Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier | Montpellier | 34295 | France |
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| Service d'urologie Hôpital Lyon Sud | Pierre-Bénite | 69310 | France |
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| Service d'urologie Hôpital Foch | Suresnes | 92151 | France |
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| Département d'urologie, andrologie et transplantation rénale Hôpital Rangueil CHU de Toulouse | Toulouse | 31059 | France |
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| D014184 | Transplantation, Homologous |