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Efficacy and tolerability of vardenafil for treatment of erectile dysfunction in patient subgroups.

OBJECTIVES: To assess whether vardenafil would improve erectile function irrespective of etiology, baseline severity, or patient age. The consistency of the response over time was also evaluated. METHODS: A multicenter, randomized, double-blind, placebo-controlled at-home study of vardenafil treatment (5, 10, and 20 mg) was performed. This secondary analysis compared the mean International Index of Erectile Function (IIEF) erectile function domain scores of various subgroups at 12 weeks of treatment. These populations included organic, psychogenic, or mixed etiologies; mild, moderate, or severe baseline severity; and four age groups (younger than 45, 45 to 55, 56 to 65, and older than 65 years). In addition, all IIEF domains were compared at sequential 4-week periods, before and during treatment. RESULTS: In the 580 men of the intent-to-treat population, the mean erectile function domain scores were statistically greater than placebo, irrespective of etiology, baseline severity, or age. This was seen at all dosages. Compared with placebo, vardenafil statistically improved the IIEF domain scores of erectile function, orgasmic function, intercourse satisfaction, and overall satisfaction after 4 weeks of treatment, and these improvements were maintained for 12 weeks. The rates of the most common adverse events (headache, flushing, and dyspepsia) were either constant or declined over time; they were generally mild to moderate and transient in nature. CONCLUSIONS: Vardenafil improved erectile function regardless of the general etiology, baseline severity of erectile dysfunction, or patient age. Improvements in erectile function and other key IIEF domains were consistently seen throughout the study.

Aged↗

[Genital and sexual manifestations occurring in the course of partial seizures in man (author's transl)].

The literature only rarely mention the genital and sexual manifestations occurring in the course of partial seizures in man. The authors presently describe 42 seizures of this type recorded with E.E.G. and Stereo-E.E.G. techniques in 15 patients. The results of this study indicate that the genital and sexual paroxystic manifestations do have a specific semeiology, and there can be related to the initial localization of the electrical discharge which may begin in one of three different regions (perisylvian region, anterior part of the cingular gyrus and the paracentral lobule). Penile erection is observed in only one seizure starting in the central region. Orgasm occurs in the only one female patient in the course of the seizures beginning in the perisylvian region (temporal region). Early sensitive symptomatology characterizes very often the seizures beginning in the perisylvian region but also in the paracentral lobule. Post-ictal or peri-ictal true masturbation occurs at the end of the ictal discharge beginning either in the perisylvian region or in the anterior part of the cingular gyrus. The sexual dyspraxic (i.e. fondling the genitals) characterizes only the post-ictal phase of the seizures beginning in any of the three regions.

Adolescent↗

Psychological and sexual aspects of the menopause and HRT.

Despite the clinical impressions that there are considerable psychological benefits from HRT, there is only clear evidence for amelioration of psychological symptoms (including improvement in cognitive function) in women who have undergone a surgical menopause. Otherwise in the natural menopause it remains unclear which, if any, non-sexual psychological symptoms respond directly to oestrogen except as a secondary response to reduction in physical symptoms. Overall, it has to be said that there is little scientific backing for hormonal treatment of psychological problems on their own around the time of the natural menopause. In most cases psychological treatment or counselling will be more appropriate than HRT. It must be remembered that the prevalence of psychological symptoms in the menopause and gynaecology clinic is high just as it is in all hospital settings. The task is to identify which women: 1. Have a predominance of psychological symptoms and might have psychiatric disorders. They may have presented in the clinic because they also happen to be menopausal, but it may well be that the psychiatric disorder has a quite independent aetiology. They will benefit from specific treatment for that disorder. 2. Have, and complain of, low moods or other non-specific psychological symptoms and have presented in the clinic because they are menopausal. They might benefit from practical, supportive help with current and ongoing stresses and strains. 3. Present appropriate menopausal complaints and only on enquiry reveal their psychological problems. In particular, disorders such as depressive illness, anxiety states and alcohol abuse can present with physical symptoms including ones which mimic vasomotor ones. This group may well be non-responders to HRT. Women requiring particular consideration might be those with other health problems (particularly chronic ones that might carry on in to old age) who are possibly more at risk of developing depression as they pass through the menopause. There is clearer evidence that HRT has beneficial effects on sexual function. When sexual symptoms are presented it is worth clarifying the exact features contributing to the complaint. Is it a problem of sexual interest, of infrequency of sexual activity, of vaginal dryness and dyspareunia, or is it a mixture of these complaints? Reduction of sexual interest and reduced sexual activity with the partner and possibly orgasm may accompany the menopause. Oestrogens have been shown to have some beneficial effect on sexual desire. Where oestrogen alone is ineffective, testosterone is usually beneficial. This treatment effect is particularly clear in surgically menopausal women. Non-menopausal aspects of the sexual relationship must be considered too. These aspects include the quality of the relationship, the sexual performance of the partner (since sexual desire decreases in both sexes with age), and age-related changes in self-image. These issues may need to be addressed at a simple health education level or with specific counselling. Although a woman's motivation or desire might change as a result of HRT, on its own this will not influence the frequency of intercourse or response during intercourse unless the partner variables permit this. The situation is more straightforward when problems of postmenopausal vaginal dryness and dyspareunia are the key issues. Oestrogens have been shown to be highly effective in such circumstances. It is also worth noting that regular and continued sexual activity has been found to protect against vaginal dryness.

Anxiety↗

The medicalization of female sexual dysfunction: the need for caution.

The use of drugs such as Viagra to treat sexual dysfunction in women may be beneficial in a proportion of cases. However, there are a number of barriers to understanding and predicting which women are likely to benefit, and caution is required in approaching this clinical issue. Three relevant issues are discussed: (1) Male-female differences in sexuality. Three complimentary ways in which male and female sexuality differs are considered--women have less need for their sexuality to be influenced by reproductive hormones; their needs for sexual enjoyment and orgasm are not well met by conventional vaginal intercourse; and, as a result of the disjunction between female sexual response and reproduction and a possibly greater propensity for central inhibition of sexual response, women are more susceptible to the repressive effects of social constraints on sexuality; (2) Sex therapy. While conventional forms of sex therapy are well designed to address the particular psychological needs of women as well as men, the interface between psychological processes and physiological response is not well understood. For the same reason, we should expect difficulty in predicting when pharmacological effects on sexual response will be beneficial; (3) When is a sexual problem a sexual dysfunction? It is likely that many cases of impaired sexual response or interest in women are psychologically understandable and hence adaptive reactions to problems in the sexual relationship, and hence not dysfunctions. Until we can distinguish between such adaptive inhibitions of response and those that are maladaptive dysfunctions, we will have difficulty in predicting when pharmacological treatment will be helpful.

Androgens↗

Correlates of increased sexual satisfaction.

Comparisons of nationally representative survey data of the population ages 18-54 years in 1971 (N = 2252) and 1992 (N = 1718) from Finland show that sexual satisfaction has greatly increased particularly among women. Some predictors of sexual satisfaction of men and women are examined on the basis of the 1992 survey data on people ages 18-74 years (N = 2250). Correlations between social background factors, sexual ideas and assertiveness, optional relationships, sexual practices, organism, and satisfaction with sexual intercourse were calculated. To control the simultaneous effect of the variables explaining satisfaction, path analyses were conducted. Results show that young age, a sexually unreserved and a nonreligious childhood home, early start of sexual life, high education, sexual assertiveness, considering sexuality important in life, reciprocal feeling of love, use of sex materials, frequent intercourse, many-sided (versatile) sexual techniques, and frequent orgasm correlate with finding sexual intercourse pleasurable. There were some gender differences in the connections between the independent factors and satisfaction with coitus. The importance of sexuality in life, love, and the use of sexual materials were connected directly to physical sexual satisfaction among men but only indirectly among women. For women, but not for men, young age and early start of sexual life correlated with enjoyment of intercourse. The greater sexual dissatisfaction of women compared to men, which still prevails, may be due to their late start of sexual life, conservative sexual attitudes, unimportance of sexuality in life, lack of sexual assertiveness, and use of restricted sexual techniques. The emancipation of women may change these ideas and practices of women. This might lessen the gender gap in physical sexual satisfaction.

Adolescent↗

Controlled prospective longitudinal study of women with cancer: I. Sexual functioning outcomes.

The incidence and etiology of sexual difficulties for women with survivable cancer were studied. Women with early stage gynecologic cancer (n = 47) were assessed after their diagnosis but prior to treatment and then reassessed at 4, 8, and 12 months posttreatment. Sexual and medical outcomes were compared with data from members of two matched comparison groups who were also assessed longitudinally: women diagnosed and treated for benign gynecologic disease (n = 18) and gynecologically healthy women (n = 57). Global sexual behavior disruption did not occur, but the frequency of intercourse declined for women treated for disease, whether malignant or benign. In relation to the sexual response cycle, diminution of sexual excitement is pronounced for women with disease; however, this difficulty is more severe and distressing for women with cancer, possibly due to significant coital and postcoital pain, premature menopause, treatment side effects, or a combination. Changes in desire, orgasm, and resolution phases of the sexual response cycle may also occur, but they are of lesser magnitude or duration or both. Approximately 30% of the women treated for cancer were diagnosed with a sexual dysfunction. The nature, early timing, and maintenance of sexual functioning morbidity suggest the instrumental role that cancer and cancer treatments play in these deficits (particularly arousal problems) and suggest that preventive therapies are necessary.

Adult↗

Women's sexuality: behaviors, responses, and individual differences.

Classic and contemporary approaches to the assessment of female sexuality are discussed. General approaches, assessment strategies, and models of female sexuality are organized within the conceptual domains of sexual behaviors, sexual responses (desire, excitement, orgasm, and resolution), and individual differences, including general and sex-specific personality models. Where applicable, important trends and relationships are highlighted in the literature with both existing reports and previously unpublished data. The present conceptual overview highlights areas in sexual assessment and model building that are in need of further research and theoretical clarification.

Female↗

Sexual functions after high-dose chemotherapy in survivors of germ cell tumors.

We investigated the changes in sexual function in male patients with germ cell tumor continuously disease free after one or two courses of high-dose chemotherapy with hematopoietic stem cell support. A questionnaire was mailed to 35 patients, and 30 patients sent it back. Sexuality was considered a problem by 10 patients (33%), but no patients considered sexuality a major problem. Erection was more difficult to achieve in seven patients (23%) and 10 patients (33%) experienced increased difficulty in maintaining an erection. Eight patients (27%) had the experience of less intensive and less frequent orgasm. In all, 13 patients (43%) thought that both the disease and treatment had worsened their sexual capacity, but 20 patients (67%) were satisfied with their sex life. Most of the patients (63%) considered that insufficient information and counselling had been given by their physicians about the sexual sequelae of therapy. However, the amount of information about the disease and treatment was considered good by 77 and 80% of the patients, respectively. This study shows that 27% of patients were not content with their ability to attain sexual satisfaction due to the illness or its treatment. Communication is an important issue and better information tools could lead to improved compliance in these patients.

Adolescent↗

Sex, drugs, and hypertension: a methodological approach for studying a sensitive subject.

Sexual dysfunction is a recognized side effect of hypertension and antihypertensive medications in men, but is not established as a side effect in women, due to the lack of established methodology. An ambulatory medical record-based, case-control study was designed to study sexual function in treated and untreated hypertensive women and healthy controls. The research was performed in a teaching hospital with satellite clinics in upstate New York. There were 3312 medical records reviewed, 640 premenopausal Caucasian women in heterosexual relationships subjects were eligible for participatic diagnosis of mild hypertension (BP > or =140/90 mmHg and < 160/100 mmHg) for cases; no other significant medical history. A total of 241 women agreed to participate, 224 (35%) completed both a self-administered questionnaire and a telephone interview (112 healthy, 112 hypertensive). There was an initial 74% response rate among those eligible to participate, with 35% completing the entire study. Age and average blood pressure were not significant between 224 participants and 416 nonparticipants by 2-tailed t-test analysis. Seven composite variables were formed from a 47-item sexual response questionnaire. Initial unadjusted chi2 results reported women with hypertension had more difficulty than did healthy controls achieving lubrication and orgasm. Seven questions, each with the highest correlation to its respective composite variable (by Spearman's correlation), formed an abbreviated questionnaire. Quality of female sexual function was quantified in an ambulatory outpatient setting. A method was described to address hypertension, pharmacotherapy, and sexual functioning by employing self-administered questionnaires and telephone interviews. Initial analysis suggested that hypertensive women may have an impaired physiological sexual response. The abbreviated questionnaire generated from questions with the highest correlation to their respective composite variables may be useful in further evaluating this issue.

Adult↗

Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men.

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.

Administration, Oral↗

Update on central function relevant to sex: remodeling the basis of drug treatments for sex and the brain.

Sexual function draws on a complex network of peripheral and central neural pathways. The standard focus on erectile difficulties and peripheral therapies has been highly successful clinically but there are many unresolved issues in men and newly discussed issues in women that will likely benefit from improved understanding of the central nervous system and sexual function. The spectrum of future therapies, based on evolving central neurophysiological understanding, will include the management of problems related to orgasm, ejaculation, desire, motivation, anxiety, and pleasure. This new range of therapies will employ old and new neurochemicals and pathways singly or in combination. The capability of hormones to modulate many of the sexual pathways will also contribute to the rise of multiagent therapy. The expanded understanding, in combination with enhanced imaging technologies, will renew the role of diagnosis and cause-specific treatment.

Animals↗

Satisfaction with the malleable penile prosthesis among couples from the Middle East--is it different from that reported elsewhere?

No studies from the Middle East have investigated the psychosexual aspects of penile prosthesis. Therefore, several questions were used herein to address satisfaction with the use of malleable penile prosthesis among couples from this geographic area, as an option to treat erectile dysfunction (ED). A total of 50 patients who underwent the insertion of AMS 650 and Acu-form penile prostheses and their partners were evaluated with a retrospective clinical record review, as well as patient and partner questionnaires. In all, 70% of the patients and 57% of the partners were satisfied with the prosthesis. There was an increase in frequency of intercourse, sexual desire, and ability to achieve orgasm. Dislike for the device was the most common cause for nonsatisfaction of patients with the device, while sense of unnaturalness was that for partners. Results from this evaluation highlight the obvious need for proper preoperative counseling for both the patient and his partner to minimize unrealistic expectations. They also emphasize the importance of careful screening of both psychosocial and psychosexual aspects of the couple based on cultural ethnic background, since these are important predictors of the therapeutic outcome of prosthesis insertion. Efforts to extend information about ED to the public may be useful to reduce patients' exaggerated embarrassment about this problem and make their partners actively involved in the treatment.

Adolescent↗

Sexual functioning in a population-based study of men aged 40-69 years: the good news.

The aim of the study was to provide cross-sectional data on age-related sexual functioning of men aged 40-69 y. The study was a randomised age-stratified community-based sample survey. In all, 799 men from two comparable middle-sized areas of Belgium participated in the study. Trained male nurses visited each participant at home and conducted a structured interview during which the participants filled out the International Index of Erectile Function (IIEF). The main outcome measures were scores on the IIEF questionnaire at item level. This study showed that 69% of the sample attempted to have intercourse during the past 4 weeks with an age-related increase in the proportion of sexually inactive men (11% at age 40-49 y; 25% at age 50-59 y; 52% at age 60-69 y; P=0.0001). Almost 90% of sexually active men reported to be able to get and keep an erection until completion of intercourse, to ejaculate with a feeling of orgasm, and reported to be satisfied with their sexual partner relation and their overall sex life. About 75% of sexually active men reported to be (very) highly confident about their erectile functioning. Only 15% of sexually inactive men reported a high to very high frequency and strong to very strong level of sexual desire. Whereas 26% still reported high to very high confidence in their erectile capacity, 34% reported to be moderately to (very) satisfied with their sexual life. This study showed that sexuality still matters at middle to high age and that it deserves to be regarded as an important and continuing aspect of the overall adaptation to getting older.

Adult↗

Sexual problems among women and men aged 40-80 y: prevalence and correlates identified in the Global Study of Sexual Attitudes and Behaviors.

The Global Study of Sexual Attitudes and Behaviors (GSSAB) is an international survey of various aspects of sex and relationships among adults aged 40-80 y. An analysis of GSSAB data was performed to estimate the prevalence and correlates of sexual problems in 13,882 women and 13,618 men from 29 countries. The overall response rate was modest; however, the estimates of prevalence of sexual problems are comparable with published values. Several factors consistently elevated the likelihood of sexual problems. Age was an important correlate of lubrication difficulties among women and of several sexual problems, including a lack of interest in sex, the inability to reach orgasm, and erectile difficulties among men. We conclude that sexual difficulties are relatively common among mature adults throughout the world. Sexual problems tend to be more associated with physical health and aging among men than women.

Adult↗

Sexual dysfunctions in HCV patients and its correlations with psychological and biological variables.

The frequency of sexual dysfunction (SD) is not very well known in patients with chronic hepatitis C. In this study, the prevalence of SD and its correlations with psychological and biological variables was assessed in 46 HCV positive patients. The mean age of patients was 46.4+/-9.4 y; the mean duration of HCV infection was 43.4+/-34.0 months; 52% were male; 89% were living with a spouse. SD was assessed using the Arizona Sexual Experiences Scale (ASEX), the level of anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS). Biochemical parameters were also assessed. Overall, as indicated by ASEX criteria, SD was observed in 35% of our patients. Of 24 males, 21% described SD; problems with drive (25%), arousal (17%) and erection (17%) were the most frequent complaints. Of 22 female patients, 50% described SD; problems with drive (55%) arousal (50%), and reaching orgasm (59%) were the most frequent complaints. Total ASEX scores were correlated with age (P<0.07, significant at trend level), education (P<0.001), and was higher in female patients (P<0.02). After controlling for the effects of age, sex, education, duration of HCV and marital status, depression levels could still significantly predict the SD (P<0.05). Moreover, even after controlling the effects of all other variables, gamma glutamyl transpeptidase (GGT) levels could predict the SD status of the patients (P<0.05). Our results indicate that the prevalence of SD was 35% in HCV-infected patients and the level of depression and GGT levels were predictive of patients SD status.

Adult↗

Women with low libido: correlation of decreased androgen levels with female sexual function index.

The aim of the present study was to investigate a possible correlation between decreased androgen levels and female sexual function index (FSFI) in women with low libido and compare these findings with normal age-matched subjects. In total, 20 premenopausal women with low libido (mean age 36.7; range 24-51 y) and 20 postmenopausal women with low libido (mean age 54; 45-70 y), and 20 premenopausal healthy women (mean age 32.2; range 21-51 y) and 20 postmenopausal healthy women (mean age 53.5; range 48-60 y) as controls were enrolled in the current study. Women with low libido had symptoms for at least 6 months and were in stable relationships. All premenopausal patients had regular menstrual cycles and all postmenopausal patients and controls were on estrogen replacement therapy. None of the patients were taking birth control pills, corticosteroids or had a history of chronic medical illnesses. All completed the FSFI and Beck's Depression Inventory (BDI) questionnaires. Hormones measured included: cortisol; T3, T4 and TSH; estradiol; total and free testosterone; dehydroepiandrosterone sulfate (DHEA-S); sex hormone binding globulin (SHBG). We performed statistical analysis by parametric and nonparametric comparisons and correlations, as appropriate. We found significant differences between the women with low libido and the controls in total testosterone, free testosterone and DHEA-S levels and full-scale FSFI score for both pre- and postmenopausal women (P<0.05). In addition, decreased total testosterone, free testosterone and DHEA-S levels positively correlated with full-scale FSFI score and FSFI-desire, FSFI-arousal, FSFI-lubrication and FSFI-orgasm scores (P<0.05). Our data suggest that women with low libido have lower androgen levels compared to age-matched normal control groups and their decreased androgen levels correlate positively with female sexual function index domains.

Adult↗

Sexual function in women with urinary incontinence.

To date limited data exists that addresses the impact of urinary incontinence on sexual function. In the present study, we assessed sexual functions in patients with urinary incontinence and compared with healthy continent subjects by means of Female Sexual Function Index (FSFI) questionnaire. A total of 21 premenopausal incontinent women (three stress incontinence, nine overactive bladder and nine mixed incontinence) were enrolled in the study, and 18 healthy continent subjects served as controls. All subjects were asked to complete FSFI questionnaire and each FSFI domain scores including desire, arousal, lubrication, orgasm, satisfaction and pain were calculated. The mean scores in each domain were compared between the groups. Mean age of subjects with urinary incontinence and controls were 39.5+/-6.6 and 32.6+/-9.1 y, respectively. All domain scores were significantly lower in incontinent women except for pain. Among the incontinence types, no significant difference was determined in all domains of FSFI. Urinary incontinence significantly reduces sexual functions in premenopausal sexually active women.

Adult↗

Cabergoline treatment in men with psychogenic erectile dysfunction: a randomized, double-blind, placebo-controlled study.

The effectiveness of cabergoline in 50 men with psychogenic erectile dysfunction was investigated in a 4-month, randomized, placebo-controlled, double-blind study with validated psychological tests, and prolactin, follicle-stimulating hormone, luteinizing hormone and testosterone serum levels. Cabergoline treatment was well-tolerated and resulted in normalization of hormone levels in most cases. In the cabergoline-treated group, significant interactions between prolactin and testosterone serum concentrations were observed. Erectile function improved significantly. Sexual desire, orgasmic function, and the patient's and his partner's sexual satisfaction were also enhanced. Cabergoline may be an effective and safe alternative agent for men with psychogenic ED.

Adult↗