Indications et résultats des implants péniens

International audienc

Biothérapies pour les troubles de l’érection et la maladie de la Peyronie : ou en est-on ?

International audienceIntroduction: Clinical trials of cell therapy for erectile dysfunction (ED) and Peyronie's disease (PD) were recently conducted after preclinical studies.Aims: The aims of this study are to give an update on biotherapy for ED and PD and to describe the regulatory framework for these therapies.Materials and methods: A literature review was performed through PubMed and Clinical.trials.gov addressing cell therapy for ED and PD and using following keywords "erectile dysfunction", "Peyronie's disease", "stem cell", and "platelet-rich plasma".Results: Preclinical studies in rodent models have shown the potential benefit of cell therapy for ED after radical prostatectomy or caused by metabolic diseases, and PD. The tissues used to obtain the therapeutic product were bone marrow, adipose tissue and blood (PRP, platelet-rich plasma). Mechanism of action was shown to be temporary and mainly paracrine. Four clinical trials were published concerning ED after radical prostatectomy and in diabetic patients and one for PD. Eleven clinical trials including three randomized trials are currently going on. Preclinical and preliminary clinical results suggested the possibility to improve spontaneous erectile function and response to pharmaceutical treatment in initially non-responder patients. This effect is mediated by an improvement of penile vascularization. A reduction of penile curvature without side effect was noted after injections into the plaque of PD patients. Most of these therapeutic strategies using autologous cells were considered as "Advanced Therapy Medicinal Products" with strict regulatory frameworks imposing heavy constraints, in particular in case of "substantial" modification of the cells. The regulatory framework remains unclear and more permissive for PRP and cell therapy processes with extemporaneous preparation/injection and no "substantial" modifications.Conclusions: First results on cell therapy for ED and PD are promising. The regulatory framework can significantly change according to cell preparations and origins leading to various constraints. This regulatory framework is crucial to consider for the choice of the procedure

Recommandations pour l'évaluation et la prise en charge de la maladie de Lapeyronie : rapport du comité d'andrologie et de médecine sexuelle de l'AFU

International audienceIntroductionPeyronie's disease is a common cause for consultation in urology. Many controversies surround its treatment. No French Guidelines have been published so far. The Committee of Andrology and Sexual Medicine of the French Association of Urology therefore offers a series of evidence-based recommendations.Materials and methodsThese recommendations are made according to the ADAPTE method, based on European (EAU, ESSM), American (AUA, ISSM) and Canadian (CAU) recommendations, integrating French specificities due to the availability of treatments, and an update of the recent bibliography.ResultsThe assessment of the disease is clinical. Patients with functional impairment or significant psychological repercussions may be offered treatment. The benefits and drawbacks of each treatment should be explained to the patient. Regarding non-surgical treatments, no available treatment has market authorization in France. Vitamin E is not recommended. Analgesic (oral or low-intensity shock waves) or proerectile treatments may be offered as needed, as well as traction therapy. Due to the unavailability of collagenase injections, verapamil injections may be offered. Surgical treatments are to be considered in the stabilized phase of the disease, and consist of performing a plication, an incision-graft or the placement of a penile implant according to the patient's wishes, the curvature and the penis size, as well as erectile function. Combination treatments can be offered.ConclusionThe management of Peyronie's disease is complex, and the levels of evidence for treatments are generally low. The success of treatment will depend on the quality of the initial assessment, the patient's information and understanding of the expected effects, and the practitioner's experience.IntroductionLa maladie de Lapeyronie est un motif fréquent de consultation en urologie, dont le traitement reste sujet à de nombreuses controverses. Elle n’a fait l’objet d’aucune recommandation française jusqu’à présent. Le Comité d’Andrologie et de Médecine Sexuelle de l’Association Française d’Urologie propose donc une série de recommandations basées sur les preuves.Matériels et méthodesCes recommandations sont réalisées selon la méthode ADAPTE, en se basant sur les recommandations européennes (EAU, ESSM), américaines (AUA, ISSM) et canadiennes (CAU), en intégrant les spécificités françaises en raison de la disponibilité des traitements, et une mise à jour de la bibliographie récente.RésultatsL’évaluation de la maladie est clinique. Les patients présentant une gêne fonctionnelle ou un retentissement psychologique important peuvent se voir proposer un traitement. Les bénéfices et inconvénients de chaque traitement devront être explicités au patient. Concernant les traitements non chirurgicaux, aucun traitement disponible n’a l’autorisation de mise sur le marché en France. La vitamine E n’est pas recommandée. Des traitements à visée antalgiques (oraux ou ondes de choc de faible intensité) ou pro-érectiles peuvent être proposée selon le besoin, ainsi qu’une thérapie par traction. En raison de l’indisponibilité des injections de collagénase, les injections de vérapamil peuvent être proposées. Les traitements chirurgicaux sont à considérer en phase stabilisée de la maladie, et consistent en la réalisation d’une plicature, d’une incision-greffe ou de la pose d’un implant pénien en fonction du souhait du patient, de la courbure et de la taille de verge, ainsi que de la fonction érectile. Des traitements combinés peuvent être proposés.ConclusionLa prise en charge de la maladie de Lapeyronie est complexe, et les niveaux de preuve des traitements sont faibles dans l’ensemble. Le succès du traitement dépendra de la qualité de l’évaluation initiale, de l’information du patient et de sa compréhension des effets attendus, et de l’expérience du praticien