Phosphodiesterase type 5 inhibitors (PDE5-Is) have an excellent efficacy and tolerability profile and remain the first-line choice for the treatment of erectile dysfunction (ED). However, ED is still ...an underdiagnosed and undertreated condition, and many men prematurely discontinue therapy with conventional dosage formulations despite successful intercourse.
To review the unmet needs and expectations of patients with ED and describe the latest pharmaceutical innovations in the field of PDE5-I formulations designed to address these needs, with particular reference to a new orodispersible film (ODF) formulation of the PDE5-I, sildenafil.
Online literature search in PubMed and the Cochrane Library.
To identify English-language publications relevant to the aims of the present review.
Improved recognition and management of ED would enable the early diagnosis of underlying and comorbid conditions that contribute to ED, leading to improved patient health and health-related quality of life. To ensure successful outcomes and patient and partner satisfaction, the complex and personal issues that influence the patient’s needs and expectations regarding treatment for ED must be considered along with their personal experiences and preferences. Innovative drug delivery systems, including orally disintegrating formulations, have been developed as alternatives to conventional dosage forms with the aim of improving patient convenience and acceptability and enhancing compliance. These alternative formulations include the sildenafil ODF, which is designed to improve acceptance and compliance over conventional solid dosage forms and extend the treatment options for men with ED by offering a convenient and discrete dosage form of a drug with proven efficacy.
The sildenafil ODF is an example of an innovative dosage formulation for ED that can be used interchangeably with the conventional film-coated formulation to better address the needs and expectations of men with ED.
Jannini EA, Droupy S. Needs and Expectations of Patients with Erectile Dysfunction: An Update on Pharmacological Innovations in Phosphodiesterase Type 5 Inhibition with Focus on Sildenafil. Sex Med 2019;7:1–10.
Abstract Purpose The purpose of this review is to provide an overview of the pharmacology, tolerability, and efficacy of the different phosphodiesterase type 5 (PDE5) inhibitors available for the ...treatment of erectile dysfunction (ED), with a special focus on the sildenafil orodispersible tablet (ODT) formulation. Methods A literature search was performed in PubMed, EMBASE, and Cochrane Reviews using the terms erectile dysfunction , patient preference , sildenafil , and PDE5 inhibitors to identify articles published in English between May 1, 2006, and November 18, 2016. A total of 29 studies were included in this review. Findings There are substantial data in the literature on the use of PDE5 inhibitors for the treatment of ED. Oral PDE5 inhibitors have been found to be efficacious in the treatment of ED based on results from standard tools used to assess treatment outcomes, such as the Global Assessment Questionnaire 1. In addition, PDE5 inhibitors are defined as well tolerated because of the low occurrence of serious adverse effects or discomfort. Mild adverse reactions, compared with a placebo, include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash. Both the film-coated tablet and ODT formulations of sildenafil with or without water have equivalent systemic exposure. However, use of a sildenafil ODT formulation offers a convenient alternative method of administration that would be advantageous for patients with ED. Implications According to the published literature, the PDE5 inhibitors are considered an effective and well-tolerated option for the treatment of ED as determined by data generated from standard instruments used in the assessment of treatment outcomes in ED and reported types and severity of adverse effects. The sildenafil ODT formulation, which disintegrates rapidly in the mouth, is an alternative to the solid film-coated tablet formulation that offers administration benefit with the potential to improve treatment adherence, thereby enhancing the sexual health and sense of psychological well-being of patients and their partners.
Background Sexual dysfunction is an under-recognized problem in men and women with chronic kidney disease (CKD). The prevalence, correlates, and predictors of this condition in patients with CKD have ...not been evaluated comprehensively. Study Design Systematic review and meta-analysis. Setting & Population Patients treated using dialysis (dialysis patients), patients treated using transplant (transplant recipients), and patients with CKD not treated using dialysis or transplant (nondialysis nontransplant patients with CKD). Selection Criteria for Studies Observational studies conducted in patients with CKD only or including a control group without CKD. Predictor Type of study population. Outcomes Sexual dysfunction in men and women with CKD using validated tools, such as the International Index of Erectile Function, the Female Sexual Function Index (FSFI), or other measures as reported by study investigators. Results 50 studies (8,343 patients) of variable size (range, 16-1,023 patients) were included in this review. Almost all studies explored sexual dysfunction in men and specifically erectile dysfunction. The summary estimate of erectile dysfunction in men with CKD was 70% (95% CI, 62%-77%; 21 studies, 4,389 patients). Differences in reported prevalence rates of erectile dysfunction between different studies were attributable primarily to age, study populations, and type of study tool used to assess the presence of erectile dysfunction. In women, the reported prevalence of sexual dysfunction was assessed in only 306 patients from 2 studies and ranged from 30%-80%. Compared with the general population, women with CKD had a significantly lower overall FSFI score (8 studies or subgroups, 407 patients; mean difference, −9.28; 95% CI, −12.92 to −5.64). Increasing age, diabetes mellitus, and depression consistently were found to correlate with sexual dysfunction in 20 individual studies of patients with CKD using different methods. Limitations Suboptimal and lack of uniform assessment of outcome measures. Conclusions Sexual dysfunction is highly prevalent in both men and women with CKD, especially among those on dialysis. Larger studies enrolling different ethnic groups, using validated study tools, and analyzing the influence of various factors on the development of sexual dysfunction are needed.
The counterfeit phenomenon is a largely under-reported issue, with potentially large burden for healthcare. The market for counterfeit drugs used in sexual medicine, most notably type 5 ...phosphodiesterase inhibitors (PDE5i), is rapidly growing.
To report the health risks associated with the use of counterfeit medications, the reasons driving their use, and the strategies enacted to contain this phenomenon.
A systematic scoping review of the literature regarding counterfeit PDE5i was carried between January and June 2021, then updated in August 2021.
We primarily aimed to clarify the main drivers for counterfeit PDE5i use, the health risks associated, and the currently available strategies to fight counterfeiters.
One hundred thirty-one records were considered for the present scoping review. Production of fake PDE5i is highly lucrative and the lacking awareness of the potential health risks makes it a largely exploitable market by counterfeiters. Adulteration with other drugs, microbial contamination and unreliable dosages make counterfeit medications a cause of worry also outside of the sexual medicine scope. Several laboratory techniques have been devised to identify and quantify the presence of other compounds in counterfeit medications. Strategies aimed at improving awareness, providing antitampering packaging and producing non-falsifiable products, such as the orodispersible formulations, are also described.
Improving our understanding of the PDE5i counterfeit phenomenon can be helpful to promote awareness of this issue and to improve patient care.
Despite the systematic approach, few clinical studies were retrieved, and data concerning the prevalence of counterfeit PDE5i use is not available on a global scale.
The counterfeit phenomenon is a steadily growing issue, with PDE5i being the most counterfeited medication with potentially large harmful effects on unaware consumers.
Sansone A, Cuzin B, and Jannini EA. Facing Counterfeit Medications in Sexual Medicine. A Systematic Scoping Review on Social Strategies and Technological Solutions. Sex Med 2021;9:100437.
Erectile dysfunction (ED) is a multidimensional disorder with an estimated prevalence of 1% to 10% in men younger than 40 years and up to 100% in men in their 70s and 80s.
To evaluate the real-life ...characteristics and unmet needs of men with ED, its impact on well-being, and treatment rates across Europe.
Adult men in Belgium, France, Germany, Italy, Poland, Portugal, and Spain were invited to participate in the survey. Men who did not use at least a drug for sexual health in the past 3 months, had cancer or spinal cord injuries, and/or underwent non–nerve-sparing radical prostatectomy were excluded.
The 15-item International Index of Erectile Function (IIEF-15) with study-specific, self-constructed questions was used.
Overall, 940 subjects (age = 46.2 ± 13.4 years) were considered. Subjects (n = 778) using on-demand phosphodiesterase type 5 inhibitors (PDE5is) were designated “performers” (60%) without a formal ED diagnosis or “patients” with a medical diagnosis. Patients were older than performers, with more self-reported comorbidities; patients used a higher PDE5i dosage and purchased it from official pharmacies more often than performers did. Of avanafil users (n = 39), no differences in total IIEF or subdomain scores were observed after adjusting for confounders. However, avanafil users less often declared its use without an ED diagnosis and a physician prescription. Overall, the latter condition was associated with higher PDE5i-related satisfaction.
The survey shows 2 different attitudes toward ED and PDE5i use: for recreational use and without a medical prescription or with a formal diagnosis and medical prescription. Avanafil, a 2nd-generation PDE5i with a good balance between efficacy and tolerability profile, is more frequently prescribed by doctors than self-prescribed compared with other PDE5is. Because the major challenge is to decrease the high dropout of 1st-generation PDE5is, further studies will be needed to clarify this topic.
Corona G, Maggi M, Jannini EA. EDEUS, a Real-Life Study on the Users of Phosphodiesterase Type 5 Inhibitors: Prevalence, Perceptions, and Health Care-Seeking Behavior Among European Men With a Focus on 2nd-Generation Avanafil. Sex Med 2018;6:15–23.
Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce.
The aim ...of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE.
Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more.
Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire.
Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg.
The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE.
J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2021;9:100296.
Masculinity and femininity constitute the gender role construct into the general concept of sexual identity.
To investigate the relationships of attachment style, sexual orientation and biological ...sex with the gender role.
A convenience sample of 344 subjects (females = 207; males = 137) was recruited.
The Attachment Style Questionnaire (ASQ), the Kinsey Scale, and the Bem Sex Role Inventory assessed, respectively, attachment styles, sexual orientation, and masculinity/femininity was administered.
Regression analysis revealed that the confidence scale of the ASQ (secure attachment) and relationship as secondary scale of ASQ (insecure/dismissing attachment) have a predictive role toward a higher score of masculinity (β = 0.201; P = .000 and β = 0.208; P = .000, respectively), whereas the need of approval scale of the ASQ (insecure/fearful-preoccupied attachment) shows a reverse association on it (β = −0.228; P = .001). Moreover, to be a male is predictive for masculinity (β = 0.196; P = .000). Also, femininity is predicted by the confidence (β = 0.173; P = .002) and the need of approval (β = 0.151; P = .03) scales of ASQ. Instead, the relationship as secondary scale of ASQ is negatively related to femininity (β = −0.198; P = .0001). No association between non-heterosexual orientation and gender role was found.
A better knowledge of links between relational patterns and gender roles for assessment and anamnesis phases in sexual medicine.
This is the first study considering sexual orientation and biological sex in the relationship between attachment styles and gender role. The main limitation is the use of self-reported psychometric tests.
Our data indicate that a secure attachment is related to both masculinity and femininity. On the contrary, different and reverse aspects of insecure attachment style characterize masculinity and femininity. Masculinity is mostly linked to insecure/dismissing attachment, whereas femininity is linked to insecure/fearful-preoccupied attachment. Moreover, although being male is a further element in support of masculinity, sexual orientation is not associated with gender role.
Ciocca G, Zauri S, Limoncin E, et al. Attachment Style, Sexual Orientation, and Biological Sex in their Relationships with Gender Role. Sex Med. 2019;8:76–83.
The International Society for Sexual Medicine (ISSM) Ad Hoc Committee for the Definition of Premature Ejaculation developed the first evidence-based definition for lifelong premature ejaculation (PE) ...in 2007 and concluded that there were insufficient published objective data at that time to develop a definition for acquired PE.
The aim of this article is to review and critique the current literature and develop a contemporary, evidence-based definition for acquired PE and/or a unified definition for both lifelong and acquired PE.
In April 2013, the ISSM convened a second Ad Hoc Committee for the Definition of Premature Ejaculation in Bangalore, India. The same evidence-based systematic approach to literature search, retrieval, and evaluation used by the original committee was adopted.
The committee unanimously agreed that men with lifelong and acquired PE appear to share the dimensions of short ejaculatory latency, reduced or absent perceived ejaculatory control, and the presence of negative personal consequences. Men with acquired PE are older, have higher incidences of erectile dysfunction, comorbid disease, and cardiovascular risk factors, and have a longer intravaginal ejaculation latency time (IELT) as compared with men with lifelong PE. A self-estimated or stopwatch IELT of 3 minutes was identified as a valid IELT cut-off for diagnosing acquired PE. On this basis, the committee agreed on a unified definition of both acquired and lifelong PE as a male sexual dysfunction characterized by (i) ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration from the first sexual experience (lifelong PE) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired PE); (ii) the inability to delay ejaculation on all or nearly all vaginal penetrations; and (iii) negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.
The ISSM unified definition of lifelong and acquired PE represents the first evidence-based definition for these conditions. This definition will enable researchers to design methodologically rigorous studies to improve our understanding of acquired PE. Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJG, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, and Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: Report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. Sex Med 2014;2:41–59.
In 2009, the International Society for Sexual Medicine (ISSM) convened a select panel of experts to develop an evidence‐based set of guidelines for patients suffering from lifelong premature ...ejaculation (PE). That document reviewed definitions, etiology, impact on the patient and partner, assessment, and pharmacological, psychological, and combined treatments. It concluded by recognizing the continually evolving nature of clinical research and recommended a subsequent guideline review and revision every fourth year. Consistent with that recommendation, the ISSM organized a second multidisciplinary panel of experts in April 2013, which met for 2 days in Bangalore, India. This manuscript updates the previous guidelines and reports on the recommendations of the panel of experts.
The aim of this study was to develop clearly worded, practical, evidenced‐based recommendations for the diagnosis and treatment of PE for family practice clinicians as well as sexual medicine experts.
A comprehensive literature review was performed.
This article contains the report of the second ISSM PE Guidelines Committee. It offers a new unified definition of PE and updates the previous treatment recommendations. Brief assessment procedures are delineated, and validated diagnostic and treatment questionnaires are reviewed. Finally, the best practices treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with PE, in facilitating treatment of their patients.
Development of guidelines is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to a more complete understanding of the pathophysiology as well as new efficacious and safe treatments for this sexual dysfunction. We again recommend that these guidelines be reevaluated and updated by the ISSM in 4 years. Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJG, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, and Torres LO. An update of the International Society of Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation (PE). J Sex Med 2014;11:1392–1422.
The Homophobia Scale (HS) is a valid tool to assess homophobia. This test is self‐reporting, composed of 25 items, which assesses a total score and three factors linked to homophobia: ...behavior/negative affect, affect/behavioral aggression, and negative cognition.
The aim of this study was to validate the HS in the Italian context.
An Italian translation of the HS was carried out by two bilingual people, after which an English native translated the test back into the English language. A psychologist and sexologist checked the translated items from a clinical point of view. We recruited 100 subjects aged18–65 for the Italian validation of the HS. The Pearson coefficient and Cronbach's α coefficient were performed to test the test–retest reliability and internal consistency.
A sociodemographic questionnaire including the main information as age, geographic distribution, partnership status, education, religious orientation, and sex orientation was administrated together with the translated version of HS.
The analysis of the internal consistency showed an overall Cronbach's α coefficient of 0.92. In the four domains, the Cronbach's α coefficient was 0.90 in behavior/negative affect, 0.94 in affect/behavioral aggression, and 0.92 in negative cognition, whereas in the total score was 0.86. The test–retest reliability showed the following results: the HS total score was r = 0.93 (P < 0.0001), behavior/negative affect was r = 0.79 (P < 0.0001), affect/behavioral aggression was r = 0.81 (P < 0.0001), and negative cognition was r = 0.75 (P < 0.0001).
The Italian validation of the HS revealed the use of this self‐report test to have good psychometric properties. This study offers a new tool to assess homophobia. In this regard, the HS can be introduced into the clinical praxis and into programs for the prevention of homophobic behavior. Ciocca G, Capuano N, Tuziak B, Mollaioli D, Limoncin E, Valsecchi D, Carosa E, Gravina GL, Gianfrilli D, Lenzi A, and Jannini EA. Italian validation of Homophobia Scale (HS). Sex Med 2015;3:213–218.
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