, the US Food and Drug Administration (FDA) approved flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, despite concern about suboptimal risk-benefit trade-offs. OBJECTIVE To conduct a systematic review and meta-analysis of randomized clinical trials assessing efficacy and safety of flibanserin for the treatment of HSDD in women. DATA SOURCES Medical databases (among others, Embase, Medline, Psycinfo) and trial registries were searched from inception to June 17, 2015. Reference lists of retrieved studies were searched for additional publications. STUDY SELECTION Randomized clinical trials assessing treatment effects of flibanserin in premenopausal and postmenopausal women were eligible. No age, language, or date restrictions were applied. Abstract and full-text selection was done by 2 independent reviewers. DATA EXTRACTION AND SYNTHESIS Data were extracted by one reviewer and checked by a second reviewer. Results were pooled using 2 approaches depending on the blinding risk of bias. MAIN OUTCOMES AND MEASURES Primary efficacy outcomes included number of satisfying sexual events (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. Safety outcomes included, among others, 4 common adverse events (AEs): dizziness, somnolence, nausea, and fatigue. RESULTS Five published and 3 unpublished studies including 5914 women were included. Pooled mean differences for SSE change from baseline were 0.49 (95% CI, 0.32-0.67) between 100-mg flibanserin and placebo, 1.63 (95% CI, 0.45-2.82) for eDiary desire, and 0.27 (95% CI, 0.17-0.38) for FSFI desire. The risk ratio for study discontinuation due to AEs was 2.19 (95% CI, 1.50-3.20). The risk ratio for dizziness was 4.00 (95% CI, 2.56-6.27) in flibanserin vs placebo, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 1.85-2.98) for nausea, and 1.64 (95% CI, 1.27-2.13) for fatigue. Women's mean global impression of improvement scores indicated minimal improvement to no change. CONCLUSIONS AND RELEVANCE Treatment with flibanserin, on average, resulted in one-half additional SSE per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. Overall, the quality of the evidence was graded as very low. Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause.

Introduction Internet-based sex therapy for men with erectile dysfunction has been advocated as an easily accessible and cost-effective treatment. Aim To test whether Internet-based sex therapy is superior to waiting list. Methods Internet-based therapy was administered to heterosexual men with erectile dysfunction or premature ejaculation, without face-to-face contact, in a waiting-list controlled design, with pre-, post-, and follow-up measurements at 3 and 6 months posttreatment. Treatment was based on the sensate-focus model of Masters and Johnson, and supplemented with cognitive restructuring techniques. Main Outcome Measures Self-reported improvement of sexual functioning, erectile functioning (men with ED), premature ejaculation (men with PE), sexual desire, overall sexual satisfaction, and sexual self-confidence. Results Ninety-eight men participated (58 ED, 40 PE). Sexual functioning was much or somewhat improved in 40 participants (48%). In participants with ED, a near significant effect of treatment was found (P = 0.065), with higher levels of sexual desire (P < 0.05) and sexual self-confidence (P = 0.05) in treated men, in addition to improved erectile functioning (P = 0.01) and overall sexual satisfaction (P < 0.001) in both groups. In participants with PE, treatment was not superior to waiting list. In participants with ED, erectile functioning (P < 0.05) and overall sexual satisfaction (P = 0.002) improved significantly. In participants with PE, latency to ejaculation (P < 0.001), sexual desire (P < 0.05), and overall sexual satisfaction (P < 0.05) improved significantly from baseline to posttreatment, with no further changes at both follow-ups. Sexual self-confidence in men with PE remained unchanged during treatment until follow-up at 3 months posttreatment, and then was found to be improved at 6-months follow-up (P < 0.05). Conclusion Internet-based sex therapy for male erectile dysfunction was efficacious for male erectile disorder. For men with premature ejaculation, however, treatment was not superior to waiting list.

Results are described of a pilot study of the efficacy of sex therapy through the Internet for thirty-nine men with erectile dysfunction or rapid ejaculation. Treatment consisted of sex therapy (Masters & Johnson, 1970), had a duration of three months, and was conducted entirely through e-mail. Forty-six percent of the participants dropped out. Fourteen (67%) participants reported an improvement of their sexual functioning. Seven (47%) participants reported the improvement had sustained one month after termination, eight (53%) participants reported no further change. We conclude that sex therapy through the Internet may yield positive results and that further controlled studies are warranted.

Background The lifetime prevalence of women suffering from provoked vestibulodynia (PVD) is estimated to be approximately 15%. The etiology of PVD is not yet clear. Recent studies approach PVD as a chronic multifactorial sexual pain disorder. PVD is associated with pain syndromes, genital infections, and mental disorders, which are common diseases in family practice. PVD, however, is not included in the International Classification of Primary Care. Hence, the vulvovaginal symptoms, which could be suggestive of PVD, are likely to be missed. Aim To explore the relationship between specific vulvovaginal symptoms that could be suggestive of PVD (genital pain, painful intercourse, other symptoms/complaints related to the vagina/vulva), and related diseases such as pain syndromes, psychological symptom diagnoses, and genital infections in family practice. Methods A retrospective analysis of all episodes from 1995 to 2008 in 784 women between 15 and 49 years were used to determine the posterior probability of a selected diagnosis in the presence of specific vulvovaginal symptoms suggestive of PVD expressed in an odds ratio. Selected comorbidities were pain syndromes (muscle pain, general weakness, irritable bowel syndrome [IBS]), psychological symptom diagnoses (anxiety, depression, insomnia), vulvovaginal candidiasis, and sexual and physical abuse. Results Women with symptoms suggestive of PVD were 4 to 7 times more likely to be diagnosed with vulvovaginal candidiasis and 2 to 4 times more likely to be diagnosed with IBS. Some symptoms suggestive of PVD were 1 to 3 times more likely to be diagnosed with complaints of muscle pain, general weakness, insomnia, depressive disorder, and feeling anxious. Conclusion Data from daily family practice showed a clear relationship between symptoms suggestive of PVD and the diagnoses of vulvovaginal candidiasis and IBS in premenopausal women. Possibly, family doctors make a diagnosis of vulvovaginal candidiasis or IBS based only on clinical manifestations in many women in whom a diagnosis of PVD would be more appropriate.

We investigated a group of men suffering from electric dysfunction (ED) who visited the website www.erectie.info and who had received consultation through the Internet (n = 219). We measured the treatment's effectiveness using the 5-item version of the International Index of Erectile Function (IIEF-5; Rosen et al., 1996; Rosen, Cappelleri, Smith, Lipsky, & Pena, 1999) and a global assessment question (GAQ). We investigated the motives and characteristics of the users of electronics consultation using a questionnaire. After a few months, the consultation group showed a considerably higher IIEF-5 score compared with their baseline score. Eighty-one percent replied in the affirmative to the GAQ. E-consultation is likely to be effective when treating ED, especially among men who find the medium convenient and for men who experience much embarrassment.

BackgroundSexual dysfunction is prevalent in patients with type 2 diabetes mellitus, but remains one of the most frequently neglected complications in diabetes care. Both patients and care providers appear to have difficulty with discussing sexual problems in diabetes care. A sexual counselling model for care providers, such as the PLISSIT model, might be a useful tool to improve the discussion of sexual issues in patients with type 2 diabetes mellitus. PLISSIT stands for Permission, Limited Information, Specific Suggestions, and Intensive Therapy. Even though the use of the PLISSIT model has often been recommended in diabetes care, no evidence with regards to its effectiveness in patients with type 2 diabetes mellitus exists. This study describes the design of a cluster-randomised controlled trial evaluating the effectiveness of a PLISSIT-model intervention in men and women with type 2 diabetes mellitus in primary care.Methods/DesignPatients with type 2 diabetes mellitus, aged 40–75 years, who indicate to be dissatisfied about their sexual functioning and that they would like to talk about their sexual problem(s) with their general practitioner are recruited. All participants receive an information leaflet from the practice nurse. In the intervention group, each participant will also receive sexual counselling based on the PLISSIT model from their general practitioner. In the control group, usual care will be provided to those participants requesting an appointment with their general practitioner when the information leaflet was not deemed sufficient. Primary outcomes include sexual functioning, satisfaction about sexual function, and quality of life. Secondary outcomes are depressive symptoms, sexual distress, emotional well-being, and treatment satisfaction. Outcomes will be measured by means of self-report questionnaires at baseline, and after 3 and 12 months post-baseline. Treatment satisfaction will be assessed in telephone interviews.DiscussionThis paper describes the design of a cluster-randomised controlled trial that will investigate the effectiveness of a PLISSIT-model intervention in patients with type 2 diabetes mellitus in primary care. Our study will add important and currently missing insight into the effectiveness of PLISSIT on important patient-reported outcomes of men and women with type 2 diabetes mellitus.Trial registrationDutch Trial Registry NTR4807.

Background Provoked vulvodynia (PVD) is a chronic vulvar pain condition affecting up to 8.3% of the female population. Despite many years of research, no clear cause for PVD has been identified. Several risk factors have been studied, including vulvovaginal candidiasis (VVC). However, to date, the role of Candida infections in PVD has remained unclear. VVC and PVD have an overlap of symptoms that may contribute to diagnostic inaccuracy and mistreatment. Aim To systematically review the literature on the relationship between VVC and PVD. Methods Cohort and case-control studies were included that compared women with PVD with healthy controls with respect to the presence of a history of Candida vulvovaginitis. PVD had to be diagnosed by Friedrich’s criteria or the International Society for the Study of Vulvovaginal Disease criteria. The inclusion process as well as the quality appraisal of the studies, using the Newcastle-Ottawa Quality Assessment Scale, were performed independently by 2 authors. Main Outcome Measure Outcomes of the population-based case-control studies were listed as odds ratio. Outcomes of the pathophysiological studies were based on local pro-inflammatory responses on Candida in vitro. Results We included a total of 14 studies, both population and clinic-based case-control, and pathophysiological research. 7 studies were of low methodological quality, and 7 studies were of medium methodological quality. The population-based case-control studies showed a significantly increased odds ratio for self-reported VVC in PVD cases compared with controls. The pathophysiological studies revealed a tendency for an increased local proinflammatory response on Candida in vitro in patients with PVD. Owing to the substantial heterogeneity of the studies, meta-analysis was not performed. Clinical Implications Health care providers may consider a diagnosis of PVD in women with self-reported VVC, and to act on this properly. Reiteration of antifungal prescriptions by physicians without a decent diagnosis, will lead to mistreatment. Women should be informed by their health care provider that intercourse during (or shortly after) the treatment of VVC might worsen the vulnerability of the vulvar skin. Strength and Limitations This is the first systematic review performed to describe the relation between VVC and PVD. An independently performed in- and exclusion process and quality appraisal, ensured optimal internal validity. However, there were important methodological limitations and the size of heterogeneity prevented establishing a meta-analysis. Conclusion This systematic review is unable to draw conclusions regarding a relationship between actual VVC and PVD because studies were based on self-reported VVC. Until new evidence becomes available, we advocate that PVD should be considered as an unexplained chronic pain condition. In women with recurrent or persistent VVC-like complaints, physicians should consider a diagnosis of PVD.

Data on patients with a sexual dysfunction were collected in 45 Dutch general practices between 2003 and 2008. The aim of the study was to determine the incidence of patients with a sexual dysfunction, associated health problems, and related interventions performed by their general practitioners (GPs). The study design was a dynamic cohort study comparing 6 years of data on patients with a sexual dysfunction. Participating GPs were asked to record weekly all consulting patients who presented with a sexual dysfunction. In an additional questionnaire, these problems and associated interventions were specified. Incidence of sexual dysfunctions varied between 132 per 100,000 per year for male patients and 60 per 100,000 per year for female patients. Men mainly consulted a GP for erectile dysfunction, and women mainly consulted a GP for hypoactive sexual desire disorder and dyspareunia. Sexual desire problems were more often associated with comorbid problems such as psychological and relationship problems and medication use than other sexual dysfunctions. Female patients showed more co-occurrence of sexual dysfunction and were more often referred to secondary care services than were male patients. During the period of 2003 to 2008, the help-seeking pattern of men and women consulting their GP for a sexual dysfunction appears to be stable. The presence of comorbid problems indicates that GPs are often dealing with complex multifactorial dynamics. Co-occurrence of sexual dysfunction among women probably resulted in a higher referral rate to secondary care services. Therefore, a gender-sensitive approach and an open mind to differences in sexual identity are needed for counseling in and treatment of sexual dysfunction.