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Clinical efficacy and safety of Vitaros©/Virirec© (Alprostadil cream) for the treatment of erectile dysfunction

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  • Hospital Sanitas La Zarzuela, Madrid, Spain

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Erectile dysfunction (ED) is a very common disorder with a deep impact on patients and their partners. Several options are now available for treating ED; oral pharmacotherapy with phosphodiesterase-5 (PDE5) inhibitors currently represents the first-line option for many ED patients. Vitaros©/Virirec© is new topical, non-invasive treatment for ED that offers the combination of an active drug (alprostadil, a synthetic PGE1) with a skin enhancer that improves its local absorption directly at the site of action. Vitaros©/Virirec© has a favorable pharmacodynamic profile and is poorly absorbed in systemic circulation. This makes it suitable in any circumstances and results in a reduced risk of adverse events (AEs), being systemic AEs reported in only 3% of the treated population. Its clinical efficacy has been demonstrated in both phase II and III trials, showing a global efficacy up to 83% with the 300 μg dose in patients with severe ED significantly better than placebo. Its fast onset of action together with its favorable toxicity profile and lack of interactions with other drugs makes Vitaros©/Virirec© a first-line therapeutic option for patients with ED, particularly for individuals who are reluctant to take systemic treatments or with AEs. It may also have an important role in patients not responding to PDE5 inhibitors, particularly those with ED after radical prostatectomy.
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... Second-line therapeutic options [1] include the alprostadil, a synthetic form of prostaglandin E1 available as an intracavernous, intraurethral, or topical formulation [9]. Topical and intraurethral alprostadil are an alternative to intracavernous injections in patients who prefer a less invasive therapy [1]. ...
... mixed ED. The mean IIEF-5 score was 12.3 points (SD 3.1; range [5][6][7][8][9][10][11][12][13][14][15][16][17][18]). The answer to SEP-2 and SEP-3 was "Yes" in 105 (61.8%) and 1 (0.6%), respectively. ...
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Phosphodiesterase type 5 inhibitors (PDE5Is) are the first-line therapeutic option for erectile dysfunction (ED), while second-line therapy includes the alprostadil. Due to the different pharmacodynamic mechanism of PDE5Is and alprostadil, a synergistic action is conceivable when they are administered in combination. The aim of present study was to evaluate the efficacy and safety of combination therapy with PDE5I and topical alprostadil in patients with ED non-responders to PDE5I alone. We designed a prospective, two-arm, open-label, non-randomized study. Patients over 18 years old, with a stable sexual relationship for at least 6 months, and ED non-responders to PDE5I monotherapy were included in the study. At baseline the variables assessed were 5-item version of the International Index of Erectile Function (IIEF-5), and Sexual Encounter Profile Questions 2 and 3 (SEP-2 and SEP-3). In addition, all subjects underwent penile dynamic duplex ultrasonography. All patients were assigned to the monotherapy group (Group A) or combination therapy group (Group B) based on their preference. Topical alprostadil 300 μg/100 mg (Virirec®) was the treatment assigned to Group A, while the combination therapy with the last PDE5I taken (at the maximum recommended dose) plus topical alprostadil 300 μg/100 mg (Virirec®) was assigned to Group B. After 3 months from assignment to groups were evaluated IIEF-5, SEP-2 and SEP-3 regarding the last sexual intercourse, and Global Assessment Questionnaire-Questions 1 and 2 (GAQ-1 and GAQ-2). All adverse events (AEs) that occurred during the study period were recorded. A total of 170 patients were included in the study (72 in Group A and 98 in Group B). Fifty-two patients were previously treated with sildenafil 100 mg (30.6%), 6 with vardenafil 20 mg (3.5%), 56 with tadalafil 20 mg (32.9%), and 56 with avanafil 200 mg (32.9%). No significant differences among the study groups were found at baseline (p > 0.05). The mean IIEF-5 score increased significantly in Group B after treatment compared to baseline (12.4 ± 3.4 vs. 17.1 ± 4.5; p < 0.001), conversely patients in Group A showed no significant increase (12.2 ± 2.5 vs. 12.7 ± 3.1; p = 0.148). The number of affirmative responses to SEP-2 was significantly higher after treatment compared to baseline only in Group B (57 vs. 78; p < 0.001). The number of affirmative responses to SEP-3 was significantly higher after treatment compared to baseline in both groups (p < 0.001). The number of affirmative responses to GAQ-Q1 and GAQ-Q2 was significantly higher in Group B compared to Group A (p < 0.001). A total of 59 (34.7%) patients experienced AEs. They were mild, self-limited, and did not cause discontinuation of treatment. No episode of priapism was recorded. No statistically significant difference was recorded between the AEs of the two groups, except for facial flushing that was reported only in Group B (p = 0.021). The combination therapy with topical alprostadil and PDE5I seems to be more effective than topical alprostadil alone without worsening the safety of the treatment.
... In fact, one trial showed that intraurethral alprostadil was effective in up to 65% of patients with DM, with variable efficacy based on the severity of ED. 328 Alprostadil cream can be another promising treatment for ED. Phase 2 and 3 trials have found that alprostadil cream administered into the external urethral meatus promoted adequate erection in 74%-83% of patients, 329,330 with similarly good results in populations with diabetes and those unresponsive to PDE5is. ...
Article
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Diabetes mellitus (DM), a chronic metabolic disease characterised by elevated levels of blood glucose, is among the most common chronic diseases. The incidence and prevalence of DM have been increasing over the years. The complications of DM represent a serious health problem. The long-term complications include macroangiopathy, microangiopathy and neuropathy as well as sexual dysfunction (SD) in both men and women. Erectile dysfunction (ED) has been considered the most important SD in men with DM. The prevalence of ED is approximately 3.5-fold higher in men with DM than in those without DM. Common risk factors for the development of DM and its complications include sedentary lifestyle, overweight/obesity and increased caloric consumption. Although lifestyle changes may help improve sexual function, specific treatments are often needed. This study aimed to review the definition and prevalence of DM and ED, the impact of DM complications and DM treatment on ED and current and emerging treatments and novel approaches for the treatment of ED in patients with DM. This article is protected by copyright. All rights reserved.
... The treatment protocol for these specific causes of vasogenic ED differs. Patients with arteriogenic ED are either treated with oral phosphodiesterase inhibitors, intraurethral alprostadil (prostaglandin E 1 ), topical alprostadil which is applied 5-30 min prior to coitus, or intracavernosal alprostadil [28,29]. The more advanced therapy includes penile prosthesis, low intensity shock wave therapy and then Zotarolimus-Eluting peripheral stent treatment in those with severe inflow stenosis [30,31]. ...
Article
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Background: Erectile dysfunction (ED) is common among ageing men because of associated underlying risk factors which are peculiar to this category of patients. Endothelial dysfunction and replacement of cavernosal smooth muscles by collagen fibres are common in older men, making them prone to ED. It is either vasogenic, neurogenic, hormonal, cavernosal or psychogenic in origin, but vasogenic causes are the commonest. This study was aimed at establishing vasogenic causes among patients being evaluated for ED using Doppler ultrasound as this category of ED is amenable to either medical and/or surgical treatment. Methods: The study was conducted from July 2015 to January, 2017 at Federal Medical Centre Abuja. Nineteen consecutive patients with clinical diagnosis of erectile dysfunction were evaluated with Doppler ultrasound scan using a high-frequency linear array transducer. The penile scan was done before and after intracavernosal injection of 20 µg of Prostaglandin E 1 (PGE 1). B-mode scan of the penis was done prior to intracavernosal injection of PGE 1 , and the spectral waveforms as well as peak systolic velocity (PSV) of the CA were recorded at 5 min interval, from 5 to 50 min post-intracavernosal injection of PGE 1 , using angle of insoation ≤ 60°. Results: The age range of the patients was fifty to sixty-six years (mean: 57.4 ± 4.3 years), while the PSV of CA varied between 21.4 and 104.4 cm/s (mean: 46.2 ± 19.2) among the entire patients, between 21.4 and 22.3 cm/s (mean: 21.9 ± 0.7) among patients with arteriogenic ED, and between 25.0 and 74.9 cm/s (mean: 45.0 ± 15.5) among those with venogenic ED. Arteriogenic ED was found in two patients (10.6%), while venogenic ED was observed in seven patients, which constituted 36.8% of the entire research participants. None had Peyronie's disease, penile fracture, penile tumour or mixed arteriogenic and venogenic ED. Conclusion: 47.4% of the patients had vasogenic ED and venogenic ED was more common than arterioegenic ED in the age range considered. This categorization of ED with Doppler study is imperative before initiating therapy as treatment protocol for vasogenic ED is aetiologic specific. Erectile dysfunction (ED) is consistent inability to maintain erectile turgidity required for normal sexual performance [1, 2]. It could arise from neurogenic, vasogenic, hormonal, psychogenic or iatrogenic origin [3], but vas-cular causes are the commonest [1, 3, 4]. ED is commoner in the older men when compared with the young because of the age-related risk factors such as systemic hypertension, diabetes mellitus, hyper-lipidaemia and obesity which are more frequently seen among the aged population [1]. Medical treatment for prostatic enlargement, hypertension and psychosomatic
... The treatment protocol for these specific causes of vasogenic ED differs. Patients with arteriogenic ED are either treated with oral phosphodiesterase inhibitors, intraurethral alprostadil (prostaglandin E 1 ), topical alprostadil which is applied 5-30 min prior to coitus, or intracavernosal alprostadil [28,29]. The more advanced therapy includes penile prosthesis, low intensity shock wave therapy and then Zotarolimus-Eluting peripheral stent treatment in those with severe inflow stenosis [30,31]. ...
Article
Full-text available
Background Erectile dysfunction (ED) is common among ageing men because of associated underlying risk factors which are peculiar to this category of patients. Endothelial dysfunction and replacement of cavernosal smooth muscles by collagen fibres are common in older men, making them prone to ED. It is either vasogenic, neurogenic, hormonal, cavernosal or psychogenic in origin, but vasogenic causes are the commonest. This study was aimed at establishing vasogenic causes among patients being evaluated for ED using Doppler ultrasound as this category of ED is amenable to either medical and/or surgical treatment. Methods The study was conducted from July 2015 to January, 2017 at Federal Medical Centre Abuja. Nineteen consecutive patients with clinical diagnosis of erectile dysfunction were evaluated with Doppler ultrasound scan using a high-frequency linear array transducer. The penile scan was done before and after intracavernosal injection of 20 µg of Prostaglandin E 1 (PGE 1 ). B-mode scan of the penis was done prior to intracavernosal injection of PGE 1 , and the spectral waveforms as well as peak systolic velocity (PSV) of the CA were recorded at 5 min interval, from 5 to 50 min post-intracavernosal injection of PGE 1 , using angle of insoation ≤ 60°. Results The age range of the patients was fifty to sixty-six years (mean: 57.4 ± 4.3 years), while the PSV of CA varied between 21.4 and 104.4 cm/s (mean: 46.2 ± 19.2) among the entire patients, between 21.4 and 22.3 cm/s (mean: 21.9 ± 0.7) among patients with arteriogenic ED, and between 25.0 and 74.9 cm/s (mean: 45.0 ± 15.5) among those with venogenic ED. Arteriogenic ED was found in two patients (10.6%), while venogenic ED was observed in seven patients, which constituted 36.8% of the entire research participants. None had Peyronie’s disease, penile fracture, penile tumour or mixed arteriogenic and venogenic ED. Conclusion 47.4% of the patients had vasogenic ED and venogenic ED was more common than arterioegenic ED in the age range considered. This categorization of ED with Doppler study is imperative before initiating therapy as treatment protocol for vasogenic ED is aetiologic specific.
... Intraurethral administration of alprostadil is an alternative method of delivering this vaso-active agent. At the moment, it is available in two forms, MUSE TM (a medicated pellet) [32] and VITAROS TM (creme) [33], with data coming mostly from the use of the first. Unfortunately, only a few papers address its efficacy in neurogenic ED. ...
Article
Full-text available
Erectile Dysfunction (ED) is the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance, causing tremendous effects on both patients and their partners. The pathophysiology of ED remains a labyrinth. The underlying mechanisms of ED may be vasculogenic, neurogenic, anatomical, hormonal, drug-induced and/or psychogenic. Neurogenic ED consists of a large cohort of ED, accounting for about 10% to 19% of all cases. Its diversity does not allow an in-depth clarification of all the underlying mechanisms nor a “one size fits all” therapeutical approach. In this review, we focus on neurogenic causes of ED, trying to elucidate the mechanisms that lie beneath it and how we manage these patients.
... Alprostadil acts independently of the psychological and neurological components of the erectile function. Alprostadil is applied in drops to meatus of glans penis, where cream is absorbed directly into the corpora cavernosa proprietary skin permeation-enhancing delivery technology [4,5]. Topical alprostadil is recommended for men with vascular ED, who cannot tolerate or are not satisfied with oral therapy (sildenafil, tadalafil, vardenafil, avanafil) [6]. ...
... Its clinical efficacy has been demonstrated in both Phases II and III trials, showing a global efficacy up to 83% with the 300 μg dose in patients with severe ED significantly better than placebo. Its fast onset of action together with its favorable toxicity profile and lack of interactions with other drugs makes Vitaros © /Virirec © a first-line therapeutic option for patients with ED. [62] Cocci et al. demonstrated the first clinical trial to assess the efficacy of a new formulation of sildenafil in patients with ED. In which 139 patients administered sildenafil (100 mg) film-coated tablet (FCT) for 4 weeks, followed by a 2-week washout period and then took sildenafil (75 mg) oral dispersible film (ODF) for 4 weeks. ...
Article
A man’s aptitude to acquire and continue an erection is frequently equated with masculinity and virility and can greatly influence men’s confidence. The sexual healthiness is a significant determinant of the worth of life. Erectile dysfunction (ED) as the inability to have or sustain a penile erection long enough to have momentous sexual intercourse with a partner. As per the literature, it is revealed that the millions of men populations are suffering from ED and there is an extreme need to overcome the ED. The various natural traditional herbs, synthetic pioneered chemical entities/potentials are preferred to treat ED. The present review discusses ED therapy including drug selection, application site, and choice of formulation. Moreover, this review updates the various pharmaceutical formulation such as liposomes, ethosomes, transfersomes, nanoemulsion, self-nano-emulsifying drug delivery system, solid dispersion, penetrosomes, solid lipid nanoparticles, and nanostructured lipid carriers development in ED therapy through the oral route, topical and nasal route, etc., which are helpful for researchers to develop new nanocarriers based formulations.
Chapter
Die Erektionsstörung ist der häufigste Grund eines Mannes, wegen einer sexuellen Funktionsstörung den Arzt aufzusuchen, womit der damit verbundene enorme Leidensdruck und die erheblichen psychosozialen Auswirkungen zum Ausdruck kommen. Als Ursache für gestörte Erektionsfähigkeit (ED – Erektile Dysfunktion) kommt ein breites Spektrum psychischer, interaktioneller und somatischer Faktoren infrage, wobei von allen sexuellen Funktionsstörungen des Mannes die ED die engste Beziehung zu kardiovaskulären Risikofaktoren und zum Lebensalter besitzt und nicht selten Komorbidität von Herz-Kreislauf-Erkrankungen und metabolischen Erkrankungen, insbesondere Diabetes mellitus Typ II, ist. Es besteht Evidenz dafür, dass eine vaskulär bedingte Erektionsstörung Vorhersagewert für eine sich nach 3–5 Jahren manifestierende koronare Herzkrankheit bzw. kardiovaskuläre Ereignisse hat und daher die Möglichkeit bietet, präventiv zu intervenieren. Dies gilt insbesondere für Männer der Altersdekade 40–49. Zu Recht kann die ED als „Signatur-Dysfunktion“ des Mannes bezeichnet werden, weil sie in den vergangenen drei Jahrzehnten wie keine andere Sexualstörung bei Frau oder Mann im Fokus des wissenschaftlichen, gesellschaftlichen und kommerziellen Interesses gestanden hat. Zugleich kann die ab den 1980er-Jahren intensivierte Erforschung des Erektionsvorgangs und seiner Störungen als Geburtsstunde der modernen Sexualmedizin gewertet werden, weil bis dahin in Ermangelung ausreichender Kenntnisse und Untersuchungsmethoden die ED in der Regel als „psychogen“ klassifiziert wurde. Eine Einteilung der ED in rein organogen oder psychogen ist jedoch wenig sinnvoll, weil sie geradezu ein Paradebeispiel für die enge Verflechtung von organischen, psychischen und sozialen Faktoren ist. Es stehen effektive nichtpharmakologische sowie medikamentöse systemische und topische Behandlungsoptionen zur Verfügung, die sowohl bei psychogenen als auch somatogenen Ursachen, sofern Letztere keine zu weitgehenden Destruktionen verursacht haben, effizient sind. Die Wirksamkeit der medikamentösen Therapie ist jedoch dann am höchsten, wenn sie mit einer sexualmedizinischen Behandlung kombiniert wird, am besten mit Einbeziehung der Partnerin.
Chapter
In Anbetracht der demographischen Entwicklung mit einem Anstieg der älteren Bevölkerung werden auch bei Patienten in einem fortgeschrittenen Lebensalter andrologische Gesichtspunkte zunehmend bedeutender. Die mittlere Lebenserwartung eines Mannes stieg in den letzten 100 Jahren von 44,8 Jahren auf 74,4 Jahre.
Article
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Currently, phosphodiesterase type 5 (PDE5) inhibitors are the initial treatment option for erectile dysfunction. The reported efficacy of PDE5 inhibitors is about 70%, although it is significantly lower in difficult-to-treat subpopulations. Treatment failures might be due to the severity of the underlying pathophysiology, improper use of medication, unrealistic patient expectations, difficult relationship dynamics, severe performance anxiety, and other psychological problems. Physicians must address these issues to identify true treatment failures attributable to the drugs. This article discusses factors that might affect the response to PDE5 inhibitors and develops a strategy to maximize the overall efficacy of PDE5 inhibitors in initial non-responders to PDE5 inhibitors.
Article
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Introduction. Phosphodiesterase type 5 inhibitors (PDE5) are currently the first line treatment for erectile dysfunction (ED). However, previous research shows that PDE5 treatments have high discontinuation rates. Understanding the reasons for discontinuing PDE5 will be necessary to optimize the response to treatment. Aim. The main goals were: (i) to analyze discontinuation rate of PDE5; (ii) to identify the discontinuation predictors; and (iii) to study the reasons for discontinuation using a qualitative methodology. Main Outcome Measures. The PDE5 discontinuation rates, predictors, and reasons for discontinuation treatment. Methods. A total of 327 men with clinical diagnosis for ED who had been treated with PDE5 were successfully interviewed by telephone, after giving their informed consent by snail mail. Telephone interviews, concerning their ongoing treatment, were carried out using a standardized questionnaire form with quantitative and qualitative items. Participation rate was 71.8%. Results. Of the total sample, 160 men (48.9%) had discontinued PDE5 treatment. The discontinuation rate was higher among men with diabetes (73%) and in iatrogenic group (65%), and lower in venogenic etiology (38.7%). We differentiated three groups of men who discontinued treatment (i) during the first 3 months (55.1%); (ii) between 4 and 12 months (26.9%); and (iii) after a period of 12 months (18%). Qualitative analyses revealed diverse reasons for discontinuation: non-effectiveness of PDE5 (36.8%), psychological factors (e.g., anxiety, negative emotions, fears, concerns, dysfunctional beliefs) (17.5%), erection recovery (14.4%), and concerns about the cardiovascular safety of PDE5 (8.7%) were the most common. Older men and men whose partners were involved in the treatment, were less likely to discontinue treatment. Conclusion. Half the subjects discontinued medication. Mostly, there was a combination of factors that led to discontinuation: non-effectiveness and psychosocial factors appear to be the main reasons. Addressing those factors will allow following up with appropriate focus on relevant topics in order to improve compliance. Carvalheira AA, Pereira NM, Maroco J, and Forjaz V. Dropout in the treatment of erectile dysfunction with PDE5: A study on predictors and a qualitative analysis of reasons for discontinuation. J Sex Med 2012;9:2361–2369.
Article
Introduction: Erectile dysfunction (ED) affects over 150 million men worldwide. Oral phosphodiesterase-5 (PDE5) inhibitors are currently used as a first-line therapy and a second-line therapy with either intracavernosal (Caverject) or intraurethral (MUSE) alprostadil is required for a few men who show poor response or intolerance to PDE5 inhibitors. Areas covered: This article reviews the pharmacology, pharmacokinetics, medical applications, efficacy and safety of alprostadil in the treatment of men with ED. The goal of this article is to review the currently published clinical data of alprostadil to establish its potential role in managing men, in particular, those who fail to respond to traditional PDE5 inhibitors. Relevant articles and abstracts were reviewed from PUBMED and conference proceedings. Expert opinion: Alprostadil, a synthetic form of prostaglandin E1, is used as second-line therapy in managing men with ED. It has a unique role in men with ED secondary to diabetes and ED secondary to radical pelvic surgery (e.g., radical prostatectomy). In view of these new indications, the role of alprostadil is being redefined. Both intracavernosal and intraurethral alprostadil are approved for use in all countries, and following positive results from recent Phase III trials, topical alprostadil has gained approval in Canada.
Article
Introduction Data suggest that ED is still an underdiagnosed and undertreated condition. In addition, it seems that men with ED are unsatisfied about their relationship with their physician and with the available drugs. Aim The study aims to identify health-related characteristics and unmet needs of patients suffering from erectile dysfunction (ED) in big 5 European Union (EU) nations (France, Germany, Italy, Spain, and UK). Methods Data were collected from the 2011 5EU National Health and Wellness-Survey on a population of 28,511 adult men (mean age: 47.18; SD 16.07) and was focused on men (5,184) who self-reported ED in the past 6 months. In addition, the quality of life (QoL) and work productivity/activity were explored. Main Outcome Measures Health-related QoL (HRQoL) and work productivity were measured with SF-12v2 and WPAI validated psychometric tools. Results One in every 20 young men (age 18–39) across 5EU experienced ED in the past 6 months. About half of men (2,702/5,184; [52%]) with ED across all ages did not discuss their condition with their physician. Interestingly, among those men who did discuss their condition with their physician, 68% (1,668/2,465) do not currently use medication. These findings were more evident in the age group of 18–39 years. Only 48% (2,465/5,184) had a closer relationship with their physician, suggesting that this quality of relationship may be unsatisfactory. Compared with controls, ED patients have a significantly higher intrapsychic and relational psychopathological comorbid burden and relevant decreasing in HRQoL, with a significantly higher impairment on work productivity/activity. Conclusion Data suggest that there is a need for a new therapeutic paradigm in ED treatment which images the achievement of a new alliance between physician and patient. Hence, alternative drug delivery strategies may reduce the psychological and social impact of this disease. Jannini EA, Sternbach N, Limoncin E, Ciocca G, Gravina GL, Tripodi F, Petruccelli I, Keijzer S, Isherwood G, Wiedemann B, and Simonelli C. Health-related characteristics and unmet needs of men with erectile dysfunction: A survey in five European countries. J Sex Med 2014;11:40–50.
Article
Erectile dysfunction is a common clinical entity that affects mainly men older than 40 years. In addition to the classical causes of erectile dysfunction, such as diabetes mellitus and hypertension, several common lifestyle factors, such as obesity, limited or an absence of physical exercise, and lower urinary tract symptoms, have been linked to the development of erectile dysfunction. Substantial steps have been taken in the study of the association between erectile dysfunction and cardiovascular disease. Erectile dysfunction is a strong predictor for coronary artery disease, and cardiovascular assessment of a non-cardiac patient presenting with erectile dysfunction is now recommended. Substantial advances have occurred in the understanding of the pathophysiology of erectile dysfunction that ultimately led to the development of successful oral therapies, namely the phosphodiesterase type 5 inhibitors. However, oral phosphodiesterase type 5 inhibitors have limitations, and present research is thus investigating cutting-edge therapeutic strategies including gene and cell-based technologies with the aim of discovering a cure for erectile dysfunction.
Article
Introduction Prostate cancer is common, and, thus, more men are being treated surgically. Long-term functional outcomes are of significant importance to the patient and their partners. Erectile function (EF) preservation (rehabilitation) has gained significant traction worldwide, despite the absence of definitive evidence supporting its use. Aim To review the effectiveness of specific pharmacological therapies and other erectogenic aids in the treatment of post-radical prostatectomy (RP) erectile dysfunction. Methods A systematic literature review of original peer-reviewed manuscripts and clinical trials reported in Medline. Main Outcome Measure This review focused on the evaluation of interventions that aimed to improve EF recovery following RP. Results Although well documented in animal models, studies supporting the rehabilitation with phosphodiesterase type 5 inhibitors in humans are scarce. Daily sildenafil has been used in trials (only one randomized placebo-controlled trial) with a significant improvement in erection recovery when compared to placebo or no rehabilitation but with a low return to baseline rates (27% vs. 4% placebo). Nightly vardenafil vs. on demand vs. placebo has been studied in the Recovery of Erections: INtervention with Vardenafil Early Nightly Therapy trial with no difference in erection recovery following RP. Intracavernosal injections, although widely used and attractive from a rehabilitation standpoint, does not yet have definitive supporting its role in rehabilitation. Vacuum erection devices use following RP has been reported, but there are no data to support its role as monotherapy. Intraurethral alprostadil was also studied vs. sildenafil in a multicenter, randomized, open-label trial, and no superiority was found. Conclusions At this time, we are unable to define what represents the optimal rehabilitation program in regard to strategies utilized, timing of intervention, or duration of treatment. Mulhall JP, Bivalacqua TJ, and Becher EF. Standard operating procedure for the preservation of erectile function outcomes after radical prostatectomy. J Sex Med 2013;10:195-203.
Article
Erectile dysfunction (ED) is thought to affect some 150 million men worldwide, but many men with ED symptoms do not seek treatment. Existing surveys suggest that men with severe ED and who report support from their partners are more likely to receive treatment than were others. Less is known, however, concerning the influence of sociomedical factors such as income and body composition on receipt of treatment. The aim of this study was to determine the importance of socioeconomic status, comorbidities, and body composition on receipt of treatment for ED symptoms. We used data on 638 men enrolled in the Boston Area Community Health (BACH) survey reporting ED symptoms and/or treatment for ED as evidenced by phosphodiesterase type 5 inhibitor (PDE5i) use. Logistic regression was employed to assess the relative strength of association between receipt of treatment and socioeconomic factors, body mass index, and medical factors. A replication of these results was then provided via a parallel model using the 2004 follow-up of the Men's Attitudes to Life Events and Sexuality (MALES). In BACH, ED was deemed present if a subject scored 16 points or fewer on the five-item International Index of Erectile Function or reported PDE5i use. In MALES, presence of ED was indicated by use of a validated single question querying ED severity. Controlling for age, body composition and other factors, increased household income, availability of a sexual partner, and provider diagnosis of high blood pressure were positively associated with treatment seeking via the use of PDE5i therapy in BACH. Results on data available in MALES produced similar results for household income and partner availability. These data provide evidence that financial disadvantage may present a barrier to treatment of ED, an increasingly important sentinel marker of the cardiovascular and overall health among aging men.