Efficacy of Once-Daily Administration of Udenafil for 24 Weeks on Erectile Dysfunction: Results from a Randomized Multicenter Placebo-Controlled Clinical Trial

IntroductionThe method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration.AimThe aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction (ED) for intermediate-term period.MethodsThis multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50 mg, udenafil 75 mg). Subjects were treated with each medication once daily for 24 weeks.Main Outcome MeasuresSubjects were asked to complete the International Index of Erectile Function (IIEF)-erectile function (EF) domain at baseline, 12 weeks, and 24 weeks and the development of adverse drug reactions (ADRs) was inspected.ResultsBoth dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks. When patients were divided according to the severity of baseline EF score, significant improvement was observed only with udenafil 75 mg regardless of the degree of ED. At 24 weeks, the proportions of patients who reported a return to normal EF (IIEF-EF over 26) were 39.1% for udenafil 50 mg and 47.0% for udenafil 75 mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, and 17.9% for placebo, udenafil 50 mg, and 75 mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75 mg group (P = 0.024), the majority were mild and recovered without treatment.ConclusionsOnce-daily administration of udenafil 50 mg and 75 mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75 mg improves EF regardless of the baseline degree of ED. Moon KH, Ko YH, Kim SW, Moon DG, Kim JJ, Park NC, Lee SW, Paick J-S, Ahn TY, Chung WS, Min KS, Park JK, Yang DY, and Park K. Efficacy of once-daily administration of udenafil for 24 weeks on erectile dysfunction: Results from a randomized multicenter placebo-controlled clinical trial. J Sex Med 2015;12:1194–1201.     

Moving Toward Empirically Based Standardization in the Diagnosis of Delayed Ejaculation

BackgroundCriteria for delayed ejaculation (DE) rely on a long ejaculation latency (EL) time, lack of control/advancement regarding ejaculation, and associated bother/distress; yet, few studies have investigated these criteria in men who indicate the desire to ejaculate sooner during partnered sex.AimTo help standardize criteria for DE by better understanding characteristics of men who desire to ejaculate sooner during partnered sex in terms of their EL, reported ejaculatory control, and level of bother/distress, as well as their perceptions of typical and ideal ELs for men in general and of ELs for men with premature ejaculation (PE).MethodsA total of 572 men recruited through social media responded to an online survey regarding their EL, as well as typical, ideal, and PE ELs of men in general. They also rated (i) their ability to control and/or advance ejaculation and (ii) their level of associated bother/distress. 4 comparison groups were then established: men with probable DE (with [DE1] and without [DE2] ejaculatory control issues), a reference group with no ejaculatory disorders, and men who identified as having PE.OutcomesTo demonstrate differences in EL, ejaculatory control, and bother/distress between men with delayed ejaculation and the control and PE reference groups.ResultsELs for men with probable DE were twice as long as those with no ejaculatory disorders. When probable DE men were further subdivided into DE2 and DE1, differences were greater for the DE2 group. DE2 men also differed significantly from the reference group on ejaculatory control/advancement but not on bother/distress. Both DE and reference groups differed from the PE group.Clinical ImplicationsUsing both EL and ejaculatory control are useful in distinguishing men with delayed ejaculation from men without delayed ejaculation.Strengths & LimitationsA sizable sample drawn from a multinational population powered the study, whereas the use of social media for recruitment limited the generalizability of findings.ConclusionBoth EL and ejaculatory control differentiate men with probable DE from a control reference group having no ejaculatory disorders. Differences in bother/distress did not emerge as significant. Implications for diagnosing men with DE are presented.Rowland DL, Cote-Leger P. Moving Toward Empirically Based Standardization in the Diagnosis of Delayed Ejaculation. J Sex Med 2020;17:1896–1902.     

Sexual Desire Discrepancy as a Feature,Not a Bug,of Long‐Term Relationships: Women's Self‐Reported Strategies for Modulating Sexual Desire

IntroductionSexual desire discrepancy is commonly reported by couples in long‐term romantic relationships. Given the idiosyncratic nature of desire, and the lack of a “one size fits all” model approach to address desire concerns, it is useful to understand more about the range of ways that women and their partners modulate sexual desire.AimThis study aims to assess women's strategies to influence their sexual desire and the self‐reported effectiveness of these strategies.MethodsOne hundred seventy‐nine women who had been in a relationship with a male partner for 5+ years completed an anonymous Internet‐based survey.Main Outcome MeasuresParticipants responded to three open‐ended items about the strategies they use to address desire issues and how helpful those strategies are.ResultsThe most common responses regarding what participants did to get desire back on track included: communication, trying to meet partner's needs, having sex without desire, and having patience/letting time work out the problem. Women also mentioned several specific strategies they had employed: communication, scheduling sex, lingerie, and a date night. However, a large number of women discussed that the issue was not resolved, and they were dissatisfied with attempted strategies.ConclusionsThis research provides valuable insight into the construction of women's sexual desire and the strategies used to navigate sexual desire in long‐term relationships. Herbenick D, Mullinax M, and Mark K. Sexual desire discrepancy as a feature, not a bug, of long‐term relationships: Women's self‐reported strategies for modulating sexual desire. J Sex Med 2014;11:2196‐2206.     

CME Information: Sexual Health and Religion: A Primer for the Sexual Health Clinician (CME)

IntroductionSexual health is an integral part of the multifaceted human experience that is driven both by biological factors and psychological facets. Religion may provide a moral code of conduct or a sexual compass as to sexual norms and behaviors.AimThe aim of this study was to summarize the integration of sexuality and religion.MethodA review of published literature and religious texts was conducted.ResultsThe integration of religion with country or state politics and laws is a complicated dilemma and will not be discussed in the scope of this article. The extent to which an individual incorporates their religious doctrine into their sexual life is a personal and individualized choice. The sexual medicine health professional will likely encounter a diverse patient population of distinct religious backgrounds, and a primer on religion and sexuality is a much needed adjunctive tool for the clinician.ConclusionBecause religion can influence sexuality and dictate, in part, the behavioral and medical treatments for sexual complaints, the clinician should be familiar with religious guidelines regarding sexuality, and treatment should be customized and individualized. Failure to do so can impact compliance with the therapeutic interventions. Religious awareness also solidifies the therapeutic alliance between clinician and patient as it demonstrates respect and acknowledgment for patient's beliefs and autonomy. Kellogg Spadt S, Rosenbaum TY, Dweck A, Millheiser L, Pillai‐Friedman S, and Krychman M. Sexual health and religion: A primer for the sexual health clinician. J Sex Med 2014;11:1606–1619.     

Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens

BackgroundThe Determine™ HIV-1/2 Ag/Ab Combo (DC) rapid test can identify HIV-1 infection earlier than rapid antibody-only tests in plasma specimens.ObjectivesWe compared the performance of DC with a laboratory-based antigen/antibody (Ag/Ab) combo assay in plasma and evaluated antigen reactivity in whole blood specimens.Study designWe tested by DC 508 plasma specimens collected in a prospective study and 107 sequential plasma and simulated whole blood specimens from 20 seroconversion panels. Previous results using the ARCHITECT (ARC) Ag/Ab combo assay were compared to DC results. In seroconversion panels, the days from the first HIV1 RNA-positive test to first DC-reactive in plasma and whole blood was compared. McNemar’s and Wilcoxon signed rank tests were used for statistical analysis.ResultsOf 415 HIV-positive samples, ARC detected 396 (95.4%) and DC 337 (81.2%) (p < 0.0001). DC was reactive in 50.0% of ARC-reactive/MS-negative, 78.6% of ARC-reactive/MS-indeterminate, and 99.6% of ARC-reactive/MS-HIV-1-positive or −undifferentiated specimens. DC antigen reactivity was higher among ARC-reactive/MS-negative than MS-indeterminate samples. In 20 HIV-1 seroconversion panels, there was a significant difference between DC reactivity in plasma (91.1%) and whole blood (56.4%) (p < 0.0001). DC with whole blood showed a significant delay in reactivity compared to plasma (p = 0.008).ConclusionsIn plasma, DC was significantly less sensitive than an instrumented laboratory-based Ag/Ab combo assay. DC in plasma was significantly more sensitive compared to whole blood in early HIV-1 infections. With the U.S. laboratory-based diagnostic algorithm, DC as the first step would likely miss a high proportion of HIV-1 infections in early stages of seroconversion.