Quality of life and erectile dysfunction.
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Erectile Dysfunction↗
Biomedical subjects
Stanley E Althof
Publications and source records attributed to Stanley E Althof.
Books helpful to patients with sexual and marital problems.
Providing patients with helpful and timely resource materials requires clinicians to be familiar with an ever-changing and over-whelmingly large body of information. To assist clinicians in the task of assembling current useful materials, we surveyed members of the Society for Sex Therapy and Research by mail and an electronic listserve. The survey forms requested respondents to list books, videotapes, and Internet sites that they recommended to their patients with specific sexual/marital problems. Fifty-two of 216 surveys were returned for a response rate of 24%. Responses were included if they were cited at least three times. Each citation was verified for accuracy and developed into an acceptable journal-quality reference. Frequency counts for responses were calculated, and a bibliography was developed.
Communication↗
Outcome measurement in female sexual dysfunction clinical trials: review and recommendations.
Defining and measuring Female Sexual Dysfunction (FSD) is a complex and challenging task. Several factors have confounded the theory and measurement of FSD including: the use of an inappropriate male paradigm; difficulty in capturing the complexity of women's sexual response; an evolving but presently untested nosology; and the relative independence between subjective and objective aspects of women's sexual response. Each of these factors have contributed to the difficulty in developing meaningful and valid endpoints for clinical trials. The Food and Drug Administration's (FDA) 2000 draft guidance document for female sexual dysfunction clinical trials recommended the use of daily diary measures as primary and self-administered questionnaires (SAQs) as secondary endpoints. Event logs or diary measures may be adequate for assessing aspects of male sexual performance (e.g., erectile function), or in other therapeutic areas with discrete and readily observable endpoints (e.g., incontinence). However, psychometric theory suggests that for female sexual dysfunction clinical trials, SAQ instruments may provide more sensitive and reliable measures of outcome. We offer an alternative set of recommendations in the hope that the FDA will reconsider its position and to serve as potential guidelines for non-industry sponsored research on female sexuality as well. First, we propose that SAQs be elevated from their current status as secondary endpoints to be considered as potential primary endpoints in clinical trials of FSD. Second, we recommend that depending on the trial design and intervention under study, either an SAQ or diary measure (typically one or the other, and not both), might serve as a primary endpoint in a clinical trial. Third, SAQs and diaries should be employed, analyzed and interpreted in their particular areas of strength. Diaries are most useful for enumerating events and/or counting frequencies. SAQs are superior at gathering subjective data related to women's sexual function. Fourth, we believe there is a theoretical basis for considering SAQs to be superior measurement tools compared to diaries in assessing sexual dysfunction in women. At present, however there is insufficient objective data to fully support this opinion. Conversely, we do not anticipate either theoretical or objective evidence to support the alternative hypothesis (that diaries are superior to SAQs). If this proves to be correct in the future, diary measures may no longer be considered as primary endpoints for FSD clinical trials. Finally, we recommend that the FDA and/or other regulatory agencies reconsider the emphasis given to the number of successful or satisfactory sexual events over time as primary endpoints because they do not definitively demonstrate whether there has or has not been any improvement in the FSD endpoint under study (e.g., sexual desire). Successful and satisfactory encounters represent an amalgam of subjective assessments that are too far removed from the essential FSD component.
Clinical Trials as Topic↗
Association between the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship Questionnaire following treatment with sildenafil citrate for men with erectile dysfunction.
OBJECTIVES: Research is lacking on the correlation between treatment satisfaction and confidence, self-esteem, and relationships for men receiving treatment for erectile dysfunction (ED). We sought to correlate scores between the validated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index and the validated Self-Esteem And Relationship (SEAR) questionnaire following treatment with sildenafil citrate (VIAGRA). METHODS: This study was based on an open-label, flexible-dose trial of 93 sildenafil-naive patients with ED. Pearson correlation coefficients between EDITS index and SEAR questionnaire scores, each of which can range from 0 to 100 (most favorable), were calculated at end of treatment (EOT). An analysis of covariance model was applied to associate changes from baseline to EOT in SEAR scores with EDITS score at EOT, controlling for baseline SEAR score. RESULTS: Significant and sizable Pearson's correlations between SEAR and EDITS scores (P < or = 0.0001; range: 0.49-0.84) were observed. A 10-point higher EDITS scores at EOT corresponded to a significant and tangible average improvement in SEAR scores from baseline to EOT (P < or = 0.0001; range: 6.6-8.7). Average SEAR scores at EOT were markedly different between patients with greater treatment satisfaction at EOT (EDITS score > or = median EDITS score of 88.6; n = 50) and those with lesser treatment satisfaction at EOT (EDITS score <88.6; n = 43). CONCLUSIONS: The data add to the validity of the SEAR questionnaire, suggest a tangible relationship between treatment satisfaction and psychosocial benefit among men with ED treated with sildenafil, and highlight the importance of assessing the psychosocial impact of ED in men undergoing treatment.
Adult↗
Psychotherapy for erectile dysfunction: now more relevant than ever.
The introduction of sildenafil in 1998 dramatically altered the treatment landscape for erectile dysfunction (ED). Although physicians now have a simple, efficacious, and safe treatment for ED, psychosocial barriers interfere with patients making effective use of these interventions. The role of psychotherapy is clearer than ever before in optimizing therapeutic outcome. The four goals of psychotherapy for ED are to identify and work through the resistances to medical intervention that lead to premature discontinuation; to reduce or eliminate performance anxiety; to understand the context in which men make love; and to implement psychoeducation and modification of sexual scripts. This article discusses three factors that make psychotherapy effective as well as outcome studies evaluating psychotherapy. By providing patients with an integrated medical/psychologic treatment, clinicians are likely to increase significantly the effectiveness of their treatment interventions for ED.
Anxiety↗