Effects of Vardenafil on Sexual Distress in Obese Men
Effects of Vardenafil on Sexual Distress in Obese Men
There are no interventional studies on the impact of sexual distress (SD) in men with obesity. We investigated the effects of vardenafil (VAR) on SD in middle-aged (mean age 49±8), healthy, obese men in the absence of premature ejaculation, ED or hypogonadism. After a 4-week run-in period, 20 men with high body mass index (BMI=40±8) and SD at the Sexual Distress Esteem Questionnaire-Male (mean score 65±20 AU) were randomized to receive either VAR 10 mg on demand (N=10) or matched-placebo (PLB, N=10). Primary endpoints were variations from baseline in the intravaginal ejaculatory latency time (IELT) measured by the stopwatch technique; secondary endpoints were variations from baseline in Self-Esteem and Relationship (SEAR) and Male Sexual Health Questionnaire-Ejaculatory domain (MSHQ-EjD) scores. VAR significantly improved IELT (P<0.0001), as well as SEAR (P<0.001) and MSHQ-EjD (P<0.005) scores, wheraes no changes were observed after PLB. Interestingly, an inverse relationship between BMI and IELT was found in all the men studied (r=0.37, P<0.001). SD in healthy obese men seems to be correlated mainly with inadequate ejaculatory control, especially in men with higher BMI. Our preliminary results suggest that treatment with VAR may improve ejaculatory control, thus ameliorating self-esteem and sexual performance in men with obesity.
Male sexual distress (SD) is a relatively recent area of study that is constantly expanding. In 1993, the National Institutes of Health introduced the term ED to replace the term 'impotence,' to indicate the inability to attain and/or maintain a sufficient erection for a satisfactory sexual performance as part of the overall multifaceted investigation of male sexual function. Very recently, the WHO defined sexual health as a 'state of physical, emotional, mental and social well-being, in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.' According to the most recent data in literature, SD may be defined as a reduction/absence of 'sexual health,' which results in a feeling of inadequacy, causing a negative impact on sexual responses, not included in the definition of classical ED or in that of 'unconventional requests.' Inadequacy can originate both from physiological modifications of male sexual functions, or from diseases, that is, dysfunctions, dysfunctional symptoms and dysmorphisms derived from andrological and non-andrological origin, which do not relate to ED (National Institutes of Health Consensus Development Panel definition), but that might also induce ED. Along with requests for situational ED, there are a variety of conditions that do not constitute a classical ED, but may be related with 'inadequate sexual health,' such as the new taxonomy of subclinical ED. These unconventional requests encompass requests for drugs not supported by a disorder or condition, and are rather aimed at enhancing sexual performance, or resulting from misunderstandings and insufficient or inadequate information. The wide variety of SD occurrence is often perceived by the specialist as a prevalent condition, accounting for almost overall 30% requests in the area of sexual medicine. SD is considered potentially curable with different approaches, ranging from an integrated psycho-sexological approach, up to a new use of PDE5-inhibitors, intended as 'tutorial therapy.' This latter implies the administration of PDE5-inhibitors aimed at the resolution of SD and, therefore, must be limited in time, whereas the conventional prescription of PDE5-inhibitors is typically a treatment for an indefinite period.
The aim of the present study was to evaluate the possible association between obesity and SD, and to investigate the efficacy of vardenafil (VAR) 10 mg compared with placebo (PLB) in producing improvement/resolution of SD in obese subjects, according to the subjective assessment of the patient.
Abstract and Introduction
Abstract
There are no interventional studies on the impact of sexual distress (SD) in men with obesity. We investigated the effects of vardenafil (VAR) on SD in middle-aged (mean age 49±8), healthy, obese men in the absence of premature ejaculation, ED or hypogonadism. After a 4-week run-in period, 20 men with high body mass index (BMI=40±8) and SD at the Sexual Distress Esteem Questionnaire-Male (mean score 65±20 AU) were randomized to receive either VAR 10 mg on demand (N=10) or matched-placebo (PLB, N=10). Primary endpoints were variations from baseline in the intravaginal ejaculatory latency time (IELT) measured by the stopwatch technique; secondary endpoints were variations from baseline in Self-Esteem and Relationship (SEAR) and Male Sexual Health Questionnaire-Ejaculatory domain (MSHQ-EjD) scores. VAR significantly improved IELT (P<0.0001), as well as SEAR (P<0.001) and MSHQ-EjD (P<0.005) scores, wheraes no changes were observed after PLB. Interestingly, an inverse relationship between BMI and IELT was found in all the men studied (r=0.37, P<0.001). SD in healthy obese men seems to be correlated mainly with inadequate ejaculatory control, especially in men with higher BMI. Our preliminary results suggest that treatment with VAR may improve ejaculatory control, thus ameliorating self-esteem and sexual performance in men with obesity.
Introduction
Male sexual distress (SD) is a relatively recent area of study that is constantly expanding. In 1993, the National Institutes of Health introduced the term ED to replace the term 'impotence,' to indicate the inability to attain and/or maintain a sufficient erection for a satisfactory sexual performance as part of the overall multifaceted investigation of male sexual function. Very recently, the WHO defined sexual health as a 'state of physical, emotional, mental and social well-being, in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.' According to the most recent data in literature, SD may be defined as a reduction/absence of 'sexual health,' which results in a feeling of inadequacy, causing a negative impact on sexual responses, not included in the definition of classical ED or in that of 'unconventional requests.' Inadequacy can originate both from physiological modifications of male sexual functions, or from diseases, that is, dysfunctions, dysfunctional symptoms and dysmorphisms derived from andrological and non-andrological origin, which do not relate to ED (National Institutes of Health Consensus Development Panel definition), but that might also induce ED. Along with requests for situational ED, there are a variety of conditions that do not constitute a classical ED, but may be related with 'inadequate sexual health,' such as the new taxonomy of subclinical ED. These unconventional requests encompass requests for drugs not supported by a disorder or condition, and are rather aimed at enhancing sexual performance, or resulting from misunderstandings and insufficient or inadequate information. The wide variety of SD occurrence is often perceived by the specialist as a prevalent condition, accounting for almost overall 30% requests in the area of sexual medicine. SD is considered potentially curable with different approaches, ranging from an integrated psycho-sexological approach, up to a new use of PDE5-inhibitors, intended as 'tutorial therapy.' This latter implies the administration of PDE5-inhibitors aimed at the resolution of SD and, therefore, must be limited in time, whereas the conventional prescription of PDE5-inhibitors is typically a treatment for an indefinite period.
The aim of the present study was to evaluate the possible association between obesity and SD, and to investigate the efficacy of vardenafil (VAR) 10 mg compared with placebo (PLB) in producing improvement/resolution of SD in obese subjects, according to the subjective assessment of the patient.
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