madman
Super Moderator
News and future perspectives of non-surgical treatments for erectile dysfunction (2022)
Celeste Manfredi, Fabio Castiglione, Mikkel Fode, Michal Lew-Starowicz , Javier Romero-Otero, Carlo Bettocchi, Giovanni Corona and on behalf of ESSM Scientific Collaboration and Partnership (ESCAP)
The significant discontinuation rate of available therapies and the paucity of curative options promoted the research on potential novel treatments suitable for erectile dysfunction patients. The aim of this study was to provide a summary of available evidence regarding the news and future perspectives related to the non-surgical treatment of erectile dysfunction. A narrative review of the literature was performed. A comprehensive search in the MEDLINE, Embase and Scopus databases was done. Papers in the English language, published until April 2022, were included. No chronological restriction was applied. Retrospective and prospective clinical studies, as well as meta-analyses, were considered. Oro-dispersible formulations of phosphodiesterase type 5 inhibitors are particularly indicated in patients who have difficulty swallowing solid dosage forms; in addition, they constitute a discrete route of administration not requiring water. Low-intensity extracorporeal shock wave therapy is indicated in mild vasculogenic erectile dysfunction and in patients with vasculogenic erectile dysfunction poorly responsive to phosphodiesterase type 5 inhibitors. Stem cell therapy, platelet-rich plasma injections, and gene therapy seem promising regenerative treatments for selected patients with erectile dysfunction. Novel oral formulations of drugs commonly used in erectile dysfunction patients have recently become part of standard clinical practice. Regenerative treatments have been emerging in recent years and could become routine curative options in the near future. Further well-designed randomized controlled trials are needed to provide conclusive evidence on this topic and guide appropriate recommendations.
INTRODUCTION
Oral phosphodiesterase type 5 inhibitors (PDE5Is) are the traditional first-line therapeutic option for ED [1]. Cognitive behavioral therapy combined with medical treatment can maximize the outcomes [2]. Intracavernous injections of vasoactive agents (e.g., alprostadil) are indicated in patients with ED not responding to PDE5Is and as a first-line therapeutic option in subjects with contraindications (e.g., nitrate medications) or concerns (e.g., drug interactions, side effects) with PDE5Is [1, 3]. Topical formulations of vasoactive agents are also available, they constitute a less invasive but also less effective alternative to intracavernous injections [1, 4, 5]. Vacuum erection devices constitute a non-pharmacological alternative in selected patients [1, 6]. Penile prosthesis implantation is indicated if the other treatments fail or when the patient asks for a definitive solution [1]. This is associated with a high patient satisfaction rate [7, 8]. Despite the limited evidence, treatments for ED are frequently combined to improve their effectiveness, especially in unresponsive patients [9–11]. In addition, despite the high efficacy and safety profile, a significant discontinuation rate for all available ED therapeutic options has been reported: 4.4–76% with PDE5Is, 18.6–79.9% with intracavernous injections of vasoactive agents, 30% with penile prostheses [12]. Ineffectiveness, adverse events (AEs), and costs seem some of the most relevant obstacles which can lead to the discontinuation of the treatments [13, 14]. In particular, a recent meta-analysis reported that PDE5Is was associated with a mean discontinuation rate of 4% per month (~50% after 1 year). Partner-related problems and lack of efficacy were the most important causes of the interruption of the therapy [15]
In the last few years, some new PDE5I oro-dispersible formulations have been introduced into the market [16]. In addition, emerging evidence regarding new ED treatments mainly based on regenerative therapy has been produced including extracorporeal shock wave [17], stem cells [18], and platelet-rich plasma (PRP) [19] therapy. The aim of this study was to provide a summary of available evidence regarding the news and future perspectives related to the non-surgical treatment of ED.
RESULTS
PDE5I: is there any news?
*0ro-dispersible formulations
*Topical formulations
*Nutraceutical alternatives
Regeneration therapy: a not-so-distant future?
*Low-intensity extracorporeal shock wave therapy (Li-ESWT
*Platelet-rich plasma (PRP) injections
*Stem cell therapy (SCT
*Gene therapy
CONCLUSIONS
ED is a condition that can generally be treated effectively. Lifestyle modification and optimization of the associated morbidities should be the first approach in all patients. ODF represents an intriguing discrete, not requiring water, new PDE5I formulation, which can potentially improve patient adherence and satisfaction compared to “traditional” formulations. Data derived from other PDE5I novel formulations are too preliminary to draw final conclusions. Li-ESWT represents a potential approach in patients with mild vasculogenic ED or vasculogenic ED not responding to PDE5Is. However, more data are advisable to support the use of LiESWT in other categories of ED patients and define its long-term outcomes. Other regenerative treatments for ED are emerging in recent years and could represent further options in the near future; however, there is not yet enough data to support their use in the clinical setting. Further well-designed RCTs are needed to improve the evidence on this topic and provide appropriate recommendations.
Celeste Manfredi, Fabio Castiglione, Mikkel Fode, Michal Lew-Starowicz , Javier Romero-Otero, Carlo Bettocchi, Giovanni Corona and on behalf of ESSM Scientific Collaboration and Partnership (ESCAP)
The significant discontinuation rate of available therapies and the paucity of curative options promoted the research on potential novel treatments suitable for erectile dysfunction patients. The aim of this study was to provide a summary of available evidence regarding the news and future perspectives related to the non-surgical treatment of erectile dysfunction. A narrative review of the literature was performed. A comprehensive search in the MEDLINE, Embase and Scopus databases was done. Papers in the English language, published until April 2022, were included. No chronological restriction was applied. Retrospective and prospective clinical studies, as well as meta-analyses, were considered. Oro-dispersible formulations of phosphodiesterase type 5 inhibitors are particularly indicated in patients who have difficulty swallowing solid dosage forms; in addition, they constitute a discrete route of administration not requiring water. Low-intensity extracorporeal shock wave therapy is indicated in mild vasculogenic erectile dysfunction and in patients with vasculogenic erectile dysfunction poorly responsive to phosphodiesterase type 5 inhibitors. Stem cell therapy, platelet-rich plasma injections, and gene therapy seem promising regenerative treatments for selected patients with erectile dysfunction. Novel oral formulations of drugs commonly used in erectile dysfunction patients have recently become part of standard clinical practice. Regenerative treatments have been emerging in recent years and could become routine curative options in the near future. Further well-designed randomized controlled trials are needed to provide conclusive evidence on this topic and guide appropriate recommendations.
INTRODUCTION
Oral phosphodiesterase type 5 inhibitors (PDE5Is) are the traditional first-line therapeutic option for ED [1]. Cognitive behavioral therapy combined with medical treatment can maximize the outcomes [2]. Intracavernous injections of vasoactive agents (e.g., alprostadil) are indicated in patients with ED not responding to PDE5Is and as a first-line therapeutic option in subjects with contraindications (e.g., nitrate medications) or concerns (e.g., drug interactions, side effects) with PDE5Is [1, 3]. Topical formulations of vasoactive agents are also available, they constitute a less invasive but also less effective alternative to intracavernous injections [1, 4, 5]. Vacuum erection devices constitute a non-pharmacological alternative in selected patients [1, 6]. Penile prosthesis implantation is indicated if the other treatments fail or when the patient asks for a definitive solution [1]. This is associated with a high patient satisfaction rate [7, 8]. Despite the limited evidence, treatments for ED are frequently combined to improve their effectiveness, especially in unresponsive patients [9–11]. In addition, despite the high efficacy and safety profile, a significant discontinuation rate for all available ED therapeutic options has been reported: 4.4–76% with PDE5Is, 18.6–79.9% with intracavernous injections of vasoactive agents, 30% with penile prostheses [12]. Ineffectiveness, adverse events (AEs), and costs seem some of the most relevant obstacles which can lead to the discontinuation of the treatments [13, 14]. In particular, a recent meta-analysis reported that PDE5Is was associated with a mean discontinuation rate of 4% per month (~50% after 1 year). Partner-related problems and lack of efficacy were the most important causes of the interruption of the therapy [15]
In the last few years, some new PDE5I oro-dispersible formulations have been introduced into the market [16]. In addition, emerging evidence regarding new ED treatments mainly based on regenerative therapy has been produced including extracorporeal shock wave [17], stem cells [18], and platelet-rich plasma (PRP) [19] therapy. The aim of this study was to provide a summary of available evidence regarding the news and future perspectives related to the non-surgical treatment of ED.
RESULTS
PDE5I: is there any news?
*0ro-dispersible formulations
*Topical formulations
*Nutraceutical alternatives
Regeneration therapy: a not-so-distant future?
*Low-intensity extracorporeal shock wave therapy (Li-ESWT
*Platelet-rich plasma (PRP) injections
*Stem cell therapy (SCT
*Gene therapy
CONCLUSIONS
ED is a condition that can generally be treated effectively. Lifestyle modification and optimization of the associated morbidities should be the first approach in all patients. ODF represents an intriguing discrete, not requiring water, new PDE5I formulation, which can potentially improve patient adherence and satisfaction compared to “traditional” formulations. Data derived from other PDE5I novel formulations are too preliminary to draw final conclusions. Li-ESWT represents a potential approach in patients with mild vasculogenic ED or vasculogenic ED not responding to PDE5Is. However, more data are advisable to support the use of LiESWT in other categories of ED patients and define its long-term outcomes. Other regenerative treatments for ED are emerging in recent years and could represent further options in the near future; however, there is not yet enough data to support their use in the clinical setting. Further well-designed RCTs are needed to improve the evidence on this topic and provide appropriate recommendations.
