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martedì 20 ottobre 2015

Disfunzione erettile. Sbarca in Italia il primo farmaco in crema

http://www.quotidianosanita.it/scienza-e-farmaci/articolo.php?articolo_id=32120


Disfunzione erettile. Sbarca in Italia il primo farmaco in crema

Indicato per pazienti con una patologia medio lieve, agisce rapidamente, tra 5 e 30 minuti. Già lanciato in Francia e Spagna, Vitaros®, il nuovo farmaco topico per il trattamento dei deficit dell’erezione ha debuttato all’88° Congresso nazionale della Società italiana di urologia.in corso a Riccione

12 OTT - Di facile utilizzo, è infatti in crema, agisce quindi localmente e anche rapidamente, tra 5 e 30 minuti, con un effetto che può permanere per più di mezz’ora, a seconda dei soggetti. Non ha interazioni negative con altri farmaci, alimenti e bevande alcoliche. Soprattutto promette di aiutare molti degli oltre 3 milioni di uomini che soffrono di deficit dell’erezione.
Sbarca ufficialmente in Italia, Vitaros® (questo il nome commerciale) il primo trattamento topico in crema destinato a chi è affetto da disfunzione erettile. Una patologia che condiziona non poco la sessualità degli uomini e la vita di relazione delle coppie, anche quando episodica o dovuta semplicemente a stress e disturbi psicologici. Un deficit che può presentarsi a qualsiasi età: anche se interessa circa il 10% degli uomini tra i 40 e i 50 anni, il 40% fra i 60 e i 70 anni e il 50% dei soggetti oltre i 70 anni, non risparmia i giovanissimi.

Dopo avere collezionato successi in Francia e Spagna, il nuovo farmaco del Gruppo Bracco è stato presentato nell’ambito dell’88° Congresso nazionale della Società italiana di urologia (Siu) in corso a Riccione.
Sviluppato negli Stati Uniti, si basa su una nuova tecnologia formulativa che permette l’assorbimento cutaneo del principio attivo (Alprostadil). È già acquistabile in confezione da quattro monodose con prescrizione medica in tutte le farmacie italiane. Creto npon è per tutti, è infatti  indicato per quei soggetti con una patologia medio lieve e che non si sono mai approcciati prima a una terapia farmacologica.
 
“La facilità d’utilizzo, con la semplice applicazione locale, in aggiunta all’efficacia clinica e alla sicurezza d’uso, rendono questo farmaco la prima linea di trattamento per i pazienti, circa il 13% della popolazione maschile, che soffrono di disfunzione erettile – ha ricordato Vincenzo Mirone, Ordinario di urologia all’Università degli Studi di Napoli “Federico II” e Segretario generale della Siu – ma queste sono percentuali sicuramente in crescita, possiamo infatti stimare che attualmente soffrono di disfunzione erettile più di 3,6 milioni di uomini. Ma a noi si rivolgono solo poco più di 900mila uomini. Due milioni di italiani quindi non si curano. È perciò una malattia ancora da disegnare, anche se ha tante opportunità di cura, abbiamo infatti quattro molecole in commercio per combattere la disfunzione erettile, ma ben venga questa nuova opportunità terapeutica che in quanto maggiormente confidente ci consente di intercettare quei pazienti che guardano con diffidenza l’utilizzo dei farmaci orali”.
 
Quella che è già stata chiamata la “crema dell’amore” è un farmaco di prima linea, indicato nei pazienti naive e che deve essere utilizzato prima delle pillole orali. Il segreto di questo prodotto è l’associazione tra l’Alprostadil, principio attivo di comprovata efficacia, e una molecola (Ddaip) capace di aumentare di molto l’assorbimento cutaneo. “La vera innovazione di questo farmaco è che non è una pillola – ha spiegatoFrancesco Montorsi, primario di urologia e Direttore scientifico all’Irccs Ospedale San Raffaele di Milano – è un vasodilatatore, migliora circolazione del sangue in questi pazienti. Lo potremmo definire una sorta di collirio. Agisce rapidamente, tra i 5 e i 30 minuti dopo l’applicazione e l’effetto può permanere per più di mezz’ora a seconda del soggetto. Può essere utilizzato una volta al giorno, ma la sua efficacia entra a regime dopo otto-dieci somministrazioni. Deve essere applicato sulla punta del pene e la prima volta sotto il controllo dello specialista”.
 
A testimoniare l’appeal del nuovo trattamento è una review pubblicata sulla rivista Urology e realizzata daIgnacio Moncada, Direttore dell’Unità urologica dell’Ospedale La Zarzuela di Madrid e  Professore Ordinario di Urologia presso l’Università Francisco De Vitoria a Madrid, e da Béatrice Cuzin dell’University Hospital E.Herriot di Lione. “Negli studi clinici – ha sottolineato Moncada – il 90,8% dei pazienti che ha utilizzato Vitaros® per otto mesi con una frequenza di somministrazione media di una volta la settimana, si è dichiarato soddisfatto del trattamento. Dopo la sua applicazione serve chiaramente una stimolazione sessuale”.
 
“È una crema per la coppia, i farmaci si rivolgono infatti all’uomo che agisce da solo. – ha dichiarato Hilke Baasch, Direttore generale del Dipartimento Farma del Gruppo Bracco – oggi grazie a Vitaros la coppia può trovare  insieme una soluzione. È infatti un nuovo strumento maneggevole ed efficace che il medico può dispensare. Sfruttando una tecnologia americana brevettata si è riusciti a realizzare un prodotto topico in crema che consente un assorbimento locale di Alprostadil, principio attivo di comprovata attività vasodilatante. Grazie a questa tecnologia innovativa, dopo 18 anni dal lancio del primo farmaco sistemico, da oggi sarà possibile trattare questa patologia anche con un prodotto che viene semplicemente applicato localmente. Vitaros® si propone ai pazienti come un’interessante alternativa al trattamento con i farmaci orali e iniettivi”.

12 ottobre 2015
© Riproduzione riservata

Altri articoli in Scienza e Farmaci 

sabato 21 dicembre 2013

http://www.biomedcentral.com/1471-2490/13/66Case report

An unusual delayed complication of paraffin self-injection for penile girth augmentation

Mario De Siati1Oscar Selvaggio1Giuseppe Di Fino1Giuseppe Liuzzi1Paolo Massenio1Francesca Sanguedolce2Giuseppe Carrieri1 and Luigi Cormio1*
1Department of Urology and Renal Transplantation, University of Foggia, Viale Pinto n° 1, 71122, Foggia, Italy
2Department of Pathology, University of Foggia, Viale Pinto n° 1, 71122, Foggia, Italy
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BMC Urology 2013, 13:66  doi:10.1186/1471-2490-13-66

The electronic version of this article is the complete one and can be found online at:http://www.biomedcentral.com/1471-2490/13/66

Received:26 August 2013
Accepted:26 November 2013
Published:1 December 2013
© 2013 De Siati et al.; licensee BioMed Central Ltd. 
This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Penile self-injection of various oils is still carried out among Eastern Europe people for penile girth augmentation despite the potential destructive complications of this practice are well known. Penile reactions to such foreign bodies include scarring, abscess formation, ulceration, and even Fournier’s gangrene; voiding problems due to mineral oil self-injection have been reported only once. To our knowledge, we describe the first case of paraffin self-injection for penile girth augmentation presenting with acute urinary retention.

Case presentation

A 27-year-old Romanian man presented with severe penile pain and acute urinary retention five years after having practiced repeated penile self-injections of paraffin for penile girth augmentation. The penile shaft was massively enlarged, fibrotic and phymotic; urethral catheterization failed due to severe stricture of the proximal pendulum urethra. The patients refused placement of a suprapubic catheter and underwent immediate penile surgical exploration. The scarred tissue between dartos and Buck’s fascia and a fibrotic ring occluding the urethra were removed and the penile skin reconstructed. Pathology confirmed the diagnosis of paraffinoma. The patient resumed normal voiding immediately after catheter removal on second postoperative day; he was very pleased with cosmetic, sexual and voiding results at six weeks, six months and 1 year follow-up.

Conclusions

The present report describes a novel complication of penile self-injection for penile girth augmentation. Because of the increasing number of patients seeking penile augmentation, physicians dealing with sexual medicine should pay more attention to such request to prevent the use of non medical treatments that can turn into medical disasters.
Keywords: 
Lipogranuloma; Penis; Male genitalia; Mineral oils

Background

Penile girth augmentation (PGA) by means of subcutaneous injection of various oils is still carried out among people from the Eastern Europe despite the potential destructive complications of this practice are well known since the early 1900s [1]. As a matter of fact, several kinds of foreign body reactions, including penile scarring and deformity, abscess formation, ulceration, erectile dysfunction and even Fournier’s gangrene, have been reported following injection of these oils [1-12]. Reactions to cod fish oil tend to occur shortly (1–2 weeks) after injection [13], whereas reactions to paraffin or mineral oil tend to occur 1 to 2 years after injection [1]; both usually cause skin scarring leading to paraphimosis and penile deformity, or skin infection leading to purulent discharge, ulceration and even necrosis. Voiding problems have previously been reported only once, in a 64-year-old man with a 9-cm firm irregular penile mass after repeated self-injections on mineral oil [2]. Herein we report the first case, to our knowledge, of penile paraffinoma presenting with acute urinary retention five years after repeated penile self-injection of paraffin for PGA.

Case presentation

A 27-year-old Romanian man presented with severe penile pain and acute urinary retention. He had an unremarkable medical history. On physical examination, the penis was massively enlarged and the foreskin phymotic while the scrotum was normal (Figure 1). He reported having practiced, approximately 5 years before, five penile self-injections of paraffin for PGA and having had, following each injection, an immediate inflammatory reaction that ceased spontaneously in a few days. The four years after the injections had been uneventful, whereas in the fifth year he noticed progressive penile swelling with increasing intercourse and voiding difficulties up to the present episode of urinary retention. Urethral catheterization failed due to severe stricture of the proximal pendulum urethra. The patients refused placement of a suprapubic catheter; therefore, penile surgical exploration was immediately carried out. Following midline dorsal penile shaft incision (Figure 2), the scarred tissue between dartos and Buck’s fascia was widely excised. Then we carried out a complete subcoronal and a midline ventral penile shaft incision to free the ventral penile portion from the scarred tissue. In this phase, a fibrotic ring occluding the urethra was encountered and removed (Figure 3). The penile incisions were finally closed and a detensioning prepubic skin plasty (transverse incision and longitudinal suture) was carried out to prevent a buried penis effect.
thumbnailFigure 1. Massively enlarged and deformed penile shaft with phymotic foreskin. Physical examination revealed a penile shaft enlarged, deformed and fibrotic, with phymotic foreskin; the scrotum was normal.
thumbnailFigure 2. Midline dorsal penile shaft incision. The operation started with a midline dorsal penile shaft incision to access and remove the scarred tissue between dartos and Buck’s fascia dorsally.
thumbnailFigure 3. Fibrotic ring occluding the urethra. Following complete subcoronal incision and midline ventral penile shaft incision, the scarred tissue of the ventral penile shaft, including a fibrotic ring occluding the urethra, was accessed and removed.
The postoperative course was uneventful; the urethral catheter was removed on second postoperative day and the patient discharged 24 hours later, after a peak flow rate of 25 mL/sec and absence of post-void residual urine having been demonstrated by uroflowmetry and bladder ultrasounds. Histological examination confirmed the diagnosis of paraffinoma, showing a foreign-body type chronic granulomatous inflammation and epithelioid giant cells. Six weeks after surgery the patient reported being satisfied with the cosmetic result (Figure 4) as well as with his sexual and voiding functions; uroflowmetry showed a peak flow rate of 26 mL/sec and there was no post-void residual urine at bladder ultrasounds. At 6- and 12- months follow-up, he continued to be very pleased with cosmetic, sexual and voiding results.
thumbnailFigure 4. Cosmetic results six weeks after surgery. Six weeks after surgery, the sutured had healed well and the patient was satisfied with cosmetic and functional results.

Conclusions

The number of patients seeking penile augmentation is continuously increasing. The vast majority of them has a normally sized and normally functioning penis but is dissatisfied by the girth. A recent study on healthy young Korean military men [14] pointed out that 24% of them underestimated their penile size. It is therefore intuitive that some of them could look for PGA.
PGA can be achieved by longitudinally grafting the tunica albuginea or by subcutaneous injection of filling substances. While grafting requires surgery, subcutaneous injection is easily carried out by medical and even non-medical personnel, thus making such procedure particularly attractive.
Filling substances used in the non-medical setting include paraffin [1], vaseline [10], mineral oil[2], cod liver oil [13], metallic mercury [3], and petroleum jelly [8]; they all could cause a foreign body reaction leading to penile scarring and deformity, abscess formation, ulceration, erectile dysfunction and even Fournier’s gangrene [1-12]. The foreign body reaction usually involves the penile skin and the dartoic fascia; conversely, involvement of tissues under Buck’s fascia is extremely rare. Reviewing the literature we found only one case of corpus cavernosum involvement [15] and one case of urethral involvement [2] leading to voiding difficulties but not urinary retention. Therefore, the present is, to our knowledge, the first reported case of urinary retention following repeated paraffin self-injections for PGA.
There are two interesting features of the reported case. The first is the delayed occurrence of the voiding problems. As mentioned above, delayed reactions tend to occur between first and second year after penile paraffin injection [1], whereas in our patient the delayed reaction occurred after approximately five years. This finding suggests that the chronic inflammatory reaction to such foreign body could theoretically reactivate at later stages and that such delayed inflammatory process is more likely to move towards the underlying tissues rather than the stabilized overlying penile skin. The second is the sudden resolution of the voiding problems after surgery. As a matter of fact, complete removal of the sclerosing lipogranuloma compressing the corpus spongiosum up to occluding the urethral lumen resulted in prompt resumal of spontaneous micturition with a normal flow rate and absence of post-void residual urine volume.
In conclusion, urologists tend to be quite indifferent to their patients’ complaints about penile girth, often proposing psychiatric consultations rather than surgical solutions. Such indifference, together with the availability of non medical treatments administered by non-medical personnel and popularized on the web, is likely responsible for patients continuing to adopt non-medical solutions in spite of their well-known risks. Physicians dealing with sexual medicine should provide more attention to these patients and search for simple surgical solutions, thus avoiding non-medical solutions that can turn into medical disasters.

Consent

Written informed consent was obtained from the patient for publication of this Case report and any accompanying images. A copy of the written consent is available for review by the Editor of this journal.

Abbreviations

PGA: Penile girth augmentation.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

MD, manuscript conception. OS, manuscript drafting. GD, manuscript drafting. GL, data acquisition. PM, data acquisition. FS, pathology support. GC, supervision. LC, supervision. All authors read and approved the final manuscript.

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Pre-publication history

The pre-publication history for this paper can be accessed here: