Longitudinal associations between post-traumatic stress disorder and metabolic syndrome severity.

BACKGROUND: Post-traumatic stress disorder (PTSD) is associated with elevated risk for metabolic syndrome (MetS). However, the direction of this association is not yet established, as most prior studies employed cross-sectional designs. The primary goal of this study was to evaluate bidirectional associations between PTSD and MetS using a longitudinal design. METHOD: A total of 1355 male and female veterans of the conflicts in Iraq and Afghanistan underwent PTSD diagnostic assessments and their biometric profiles pertaining to MetS were extracted from the electronic medical record at two time points (spanning ~2.5 years, n = 971 at time 2). RESULTS: The prevalence of MetS among veterans with PTSD was just under 40% at both time points and was significantly greater than that for veterans without PTSD; the prevalence of MetS among those with PTSD was also elevated relative to age-matched population estimates. Cross-lagged panel models revealed that PTSD severity predicted subsequent increases in MetS severity (ß = 0.08, p = 0.002), after controlling for initial MetS severity, but MetS did not predict later PTSD symptoms. Logistic regression results suggested that for every 10 PTSD symptoms endorsed at time 1, the odds of a subsequent MetS diagnosis increased by 56%. CONCLUSIONS: Results highlight the substantial cardiometabolic concerns of young veterans with PTSD and raise the possibility that PTSD may predispose individuals to accelerated aging, in part, manifested clinically as MetS. This demonstrates the need to identify those with PTSD at greatest risk for MetS and to develop interventions that improve both conditions.

Sexual dysfunction and its impact on quality of life in Chinese patients with schizophrenia treated in primary care.

PURPOSE: Sexual dysfunction in schizophrenia patients is common. In China, maintenance treatment for clinically stable patients with schizophrenia is usually provided by primary care physicians. Illness- or treatment-related sexual dysfunction in this patient population has been never studied. This study describes the prevalence and correlates of sexual dysfunction and its impact on quality of life (QOL) in patients with schizophrenia treated in primary care in China. METHOD: A total of 607 patients with schizophrenia treated in 22 randomly selected primary care services in China formed the study sample. Patients' socio-demographic and clinical characteristics including sexual function and QOL were recorded using a standardized protocol and data collection. RESULTS: Sexual dysfunction was present in 69.9% of all patients; 60.7% in males and 80.6% in females. Multiple logistic regression analysis revealed that female gender, being single, older age and use of first-generation antipsychotics were independently and significantly associated with more sexual dysfunction accounting for 23.5% of its variance (P<0.001). Unexpectedly, sexual dysfunction was not associated with lower QOL. CONCLUSIONS: High rate of sexual dysfunction was reported in the majority of patients with schizophrenia treated in primary care in China. Given its negative impact on social adjustment, QOL and treatment adherence, efforts should be made to address sexual dysfunction in this patient population.

Do baseline estrogen and testosterone affect lower urinary tract symptoms (LUTS) prior to or after pharmacologic treatment with tadalafil?

Little is known about how total testosterone and estradiol-17ß influence lower urinary tract symptoms (LUTS) in men with benign prostatic hypertrophy (BPH). We analyzed data from a subset of men aged ≥18 years randomized to tadalafil 5 mg once-daily or placebo who had ≥6 month history of LUTS and an International Prostate Symptom Score (IPSS)≥13 enrolled in one of three randomized, placebo-controlled tadalafil clinical trials (N = 958). Three specific aims were addressed, as follows: (i) To characterize enrolled men by treatment randomization and testosterone level; (ii) to assess cross-sectional associations of estradiol-17ß, testosterone, and LUTS prior to treatment with tadalafil; and, (iii) to assess longitudinal associations between baseline estradiol-17ß and testosterone and improvements or worsening of LUTS during a 12-week period of tadalafil or placebo administration. LUTS were assessed by total IPSS, IPSS voiding sub-score (IPSS-V) and IPSS storage sub-score (IPSS-S) for cross-sectional analyses, and change in total IPSS (ΔIPSS), ΔIPSS-V, and ΔIPSS-S between baseline and 12-week visit for longitudinal analyses. Correlation analyses and linear regression examined associations. Baseline testosterone was not significantly associated with IPSS. In contrast, estradiol-17ß was inversely correlated with IPSS (r = -0.08; p < 0.05) and IPSS-S (r = -0.14; p < 0.05). Tadalafil treatment resulted in greater IPSS improvements in men with lower baseline estradiol-17ß versus those with higher baseline estradiol-17ß. Lower baseline estradiol-17ß was significantly associated with modestly improved ΔIPSS-V (p = 0.04) and Δtotal IPSS (p = 0.05) but not with ΔIPSS-S, following treatment which may substantiate the role of bladder dysfunction because of nerve and smooth muscle changes in the bladder in addition to benign prostatic enlargement in LUTS. Circulating baseline testosterone did not predict ΔIPSS. Men with lower baseline estradiol-17ß levels showed greater responsiveness to tadalafil 5 mg treatment than those with higher baseline estradiol-17ß levels when responsiveness was measured using total IPSS and IPSS-V.

Rural vs. urban disparities in association with lower urinary tract symptoms and benign prostatic hyperplasia in ageing men, NHANES 2001-2008.

OBJECTIVE: The objective of this study was to investigate rural/urban and socio-demographic disparities in lower urinary tract symptoms and benign prostatic hyperplasia (LUTS/BPH) in a nationally representative population of men. METHODS: Data on men age ≥40 years (N = 4,492) in the 2001-2008 National Health and Nutrition Examination Surveys were analysed. Self-report of physician-diagnosed enlarged prostate and/or BPH medication use defined recognised LUTS/BPH. Urinary symptoms without BPH diagnosis/medications defined unrecognised LUTS/BPH. Rural-Urban Commuting Area Codes assessed urbanisation. Unadjusted and multivariable associations (odds ratios (OR)) between LUTS/BPH and covariates were calculated using logistic regression. RESULTS: Recognised and unrecognised LUTS/BPH weighted-prevalence estimates were 16.5% and 9.6%. There were no significant associations between LUTS/BPH and rural/urban status. Significant predisposing factors for increased adjusted odds of recognised and unrecognised LUTS/BPH included age, hypertension (OR=1.4;1.4), analgesic use (OR=1.4;1.4) and PSA level >4 ng/mL (OR=2.3;1.9) when adjusted for rural/urban status, race, education, income, alcohol, health insurance, health care and proton pump inhibitor (PPI) use (all p ≤ 0.1). Restricting to urban men only (N = 3,371), healthcare use (≥4visits/year) and PPI's increased adjusted odds of recognised LUTS/BPH (OR=2.0;1.6); no health insurance and

Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial.

BACKGROUND: Ospemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain). METHODS: A phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels. RESULTS: Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning. CONCLUSION: In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.

Progression and remission of urologic symptoms in the community: results of a longitudinal cluster analysis approach.

OBJECTIVE: To investigate the natural history of urologic symptom progression and remission by means of cluster analysis in a large, well-characterized cohort of men and women. METHODS: Cluster analysis was used to assign men and women to symptom clusters on the basis of the prevalence of 14 self-reported urologic symptoms. Data were analyzed from the Boston Area Community Health study at baseline (T1) and 5-year follow-up (T2). Cluster progression was defined as any change from a less symptomatic to a more symptomatic cluster; conversely, cluster remission was defined as movement from more symptomatic to less symptomatic clusters. Logistic regression models examined the association of sociodemographic, psychosocial, and health outcome measures with cluster progression and remission. RESULTS: Follow-up data were available from 4145 participants (1610 men; 2535 women). More than two thirds of men (69.2%) and women (68.2%) had stable symptom cluster assignments. Cluster progression occurred in 280 of 1610 (15.2%) men and 390 of 2535 (14.6%) women; cluster remission in 280 of 1610 (15.6%) men and 409 of 2535 (17.4%) women. In multivariate analyses, cluster progression was twice as common in men with incident depression (odds ratio = 2.43, 95% confidence interval 1.26-4.67) and 3 times more likely in men with ≥ 3 comorbidities at baseline. Urologic surgeries were uncommon in men and women and were not consistently related to cluster progression or remission. CONCLUSION: Urologic symptom clusters were relatively stable over a 5-year follow-up period for more than two thirds of men and women in our sample. Specific risk factors for progression were identified in men and women.

Effect of once-daily tadalafil on confidence and perceived difficulty in performing sexual intercourse in men who were incomplete responders to as-needed PDE5 inhibitor treatment.

INTRODUCTION: For men with erectile dysfunction (ED), the expectation of difficulty and level of confidence in achieving and maintaining an erection have an impact on sexual performance. OBJECTIVE AND METHODS: This 12-week, double-blind study investigated once-daily tadalafil (2.5 mg titrated to 5 mg or 5 mg) (n = 176) or placebo (n = 79) on confidence and perceived difficulty in performing sexual intercourse in men with ED who were incomplete responders to as-needed phosphodiesterase-5 inhibitor therapy. The Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ) were administered at baseline and 12 weeks. RESULTS: The mean change in CPSIQ for the tadalafil group was 1.8, which represents a shift from 'very low' to 'moderate' sexual confidence vs. a mean change of 0.5 in the placebo group (p < 0.0001). The mean change in DPSIQ for tadalafil was 1.6, which represents a shift from 'very difficult' to 'moderately' or 'slightly difficult' sexual performance vs. a mean change of 0.4 in the placebo group (p < 0.0001). Among men receiving tadalafil with an International Index of Erectile Function-Erectile Function (IIEF-EF) end-point score of ≥ 26 or who achieved a minimal clinically important difference in IIEF-EF score at end-point, the mean changes in CPSIQ were 3.0 and 2.4, respectively (both p < 0.0001). CONCLUSION: Once-daily tadalafil vs. placebo improves confidence and decreases difficulty in performing sexual intercourse for men with ED who were incomplete responders to as-needed PDE5 inhibitor therapy.

Psychometric validation of the Confidence in Performing Sexual Intercourse Questionnaire and Difficulty in Performing Sexual Intercourse Questionnaire.

The objective of this study was to perform psychometric testing of two new patient-reported outcome instruments (PROs), the Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and the Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ). The new PROs were administered at non-drug, run-in, baseline and end point in men with erectile dysfunction (ED) participating in a randomized clinical trial of ED treatment (Study 1, n=291) and two times within 2 weeks to men with ED participating in a web-based survey (Study 2, n=71). Psychometric tests included factor analysis, internal consistency and test-retest reliability, construct validity and responsiveness. Analysis of data from Study 1 participants (74% ≤65 years, 83% Caucasian and 75% with moderate ED) suggested one-factor solutions for both PROs with Cronbach's α >0.88. CPSIQ and DPSIQ total scores discriminated between ED severity groups showed worsening after a 4-week non-drug, run-in period, and showed improvement after 12 weeks of ED treatment (all, P<0.05). Intraclass correlation coefficients calculated for the CPSIQ and DPSIQ, using data from Study 2 participants (82% ≤65 years, 90% Caucasian and 66% with mild ED), were 0.56 and 0.83, respectively. The CPSIQ and DPSIQ show potential for augmenting existing treatment outcome measures used in the evaluation of ED treatment.

Relationship between erectile function and sexual self-confidence: a path analytic model in men being treated with tadalafil.

Sexual self-confidence has been shown to be associated with erectile function (EF) in men receiving PDE-5 inhibitor therapy; however, few studies have investigated the pathways (for example, sexual satisfaction, communication, time concerns and spontaneity) through which improvements in sexual self-confidence occur. This study examined this relationship using a path analysis model in men with ED enrolled in an open-label clinical trial of 20 mg tadalafil, administered on-demand over 12 weeks. International Index of Erectile Function and Psychological and Interpersonal Relationship Scales data were used to assess improvement in EF, sexual confidence and mediating variables. Controlling for baseline measures and covariates, the model indicated that change in sexual self-confidence was significantly associated with changes in EF (P<0.0001), sexual communication conflict (P=0.01), time concerns (P<0.0001) and spontaneity (P<0.0001). The total effect of EF on sexual self-confidence was 0.85, with 0.08 of this relationship indirectly mediated through time concerns and spontaneity. These data suggest that improved sexual confidence in men receiving treatment with a long-acting PDE-5 inhibitor occurs both directly via improved EF and indirectly via improved spontaneity and diminished time concerns.

Sildenafil in women with sexual arousal disorder following spinal cord injury.

STUDY DESIGN: Double-blind, placebo-controlled, flexible-dose study. OBJECTIVE: To evaluate the efficacy, safety and tolerability of oral sildenafil in women with female sexual arousal disorder as a result of SCI (paraplegia/tetraplegia). SETTING: The study was conducted at clinical practice sites in North America (n =23), 11 European countries (n =23), Australia (n =4) and South Africa (n =2). METHODS: 129 women were randomized and treated with sildenafil or matching placebo. A 4-week baseline period was followed by 12 weeks of treatment, which could be increased from 50 to 100 mg or decreased to 25 mg once during the treatment period, depending on efficacy and tolerability. By use of an event log, sexual activity was monitored between screening and the end of treatment. The Sexual Function Questionnaire, the Sexual Quality of Life Questionnaire-Female, a global efficacy question and Sexual Distress Question were also assessed. RESULTS: Sildenafil-treated women and placebo-treated women had an increase in their percentage of sexual activities throughout the course of the study, with no statistically significant difference between groups in the percentage of successful sexual activities at end of treatment versus baseline. There were also no statistically significant differences between sildenafil- and placebo-treated women on the aforementioned measures. The most common adverse events included headache and vasodilatation. CONCLUSION: The results of this study are similar to other reports regarding a lack of clinically meaningful benefit of sildenafil in other populations of women. SPONSORSHIP: This study was sponsored by Pfizer Inc.

Sexual activity and functioning in female scleroderma patients.

OBJECTIVE: Few studies exist on sexual activity and functioning in female patients with systemic sclerosis (SSc, scleroderma). We studied the patient-reported impact of SSc on sexual functioning among female patients. METHODS: 101 SSc patients completed the Short Form-36 (SF-36), the Female Sexual Functioning Index (FSFI) and the Female Sexual Function in Scleroderma (FSFS) questionnaires. RESULTS: Sixty patients reported being sexually active (59.4%). Reasons for sexual inactivity included lack of a partner (36.6%), personal choice (31.7%), and health status of the respondent's partner (19.5%). Only 7 subjects (17%) listed scleroderma as the primary reason for sexual inactivity. The mean FSFI score in the sexually active population was 24.9 (SD=6.7, range = 4.5-34.8) which is significantly lower than the mean score of 30.5 reported for the general population. Sexual functioning was significantly correlated with the Mental Component Score of the SF-36 (r=0.54, p<0.001) but surprisingly not with the Physical Component Score of the SF-36, age, and disease classification or duration. Several scleroderma-related problems including fatigue, body pain, vaginal dryness, and vaginal discomfort were cited as contributing to sexual difficulties. CONCLUSION: Women with scleroderma do remain sexually active overall in spite of several disease-related physical and psychological difficulties. Many of their problems are amenable to health interventions and should be addressed during health care visits.

Impact of an educational initiative on applied knowledge and attitudes of physicians who treat sexual dysfunction.

A randomized, blinded, multicenter, controlled study was undertaken to assess the impact of a multiyear continuing medical education (CME) initiative on physician knowledge and behavior in the treatment of erectile dysfunction (ED). The objective of this study was to assess the efficacy of CME and compare applied knowledge and attitude scores of participants in the Consortium for Improvement in Erectile Function (CIEF), to non-CIEF participants. Subjects were selected randomly and contacted anonymously, by mail, email and fax and requested to enroll in this study. A blinded, validated questionnaire and series of standardized patient (SP) case studies and attitude questions were given to CIEF participants, defined as those who showed an interest in learning more about ED and who took at least one CME-certified program on ED from the CIEF website and non-CIEF participants, defined as those who showed interest in learning more about ED and who took at least one CME-certified program on ED from any organization other than CIEF. The primary outcome was a comparison of subjects' scores who participated in at least one CIEF program to non-participants in CIEF programs. Subjects were also compared based on SP case scores, attitude scores, specialty, years in practice, age and gender. Answers were ranked from best to worst and assigned a corresponding value of 10...3, 2, 1 and 0 (10 being the best), assuming that there may be more than one correct answer to each question in clinical practice. SAS version 9.1 analysis of variance model was used by an independent consultant. A total of 120 physicians completed the questionnaire: 87 urologists (UROs) and 33 primary care physicians (PCPs). UROs scored higher on SP cases compared with PCPs (P=0.0039); however, as a result of participating in CIEF programs, PCPs trended toward more comparable scores to UROs; P=0.23 for SP case 2 that was clinically less complex and P=0.19 for SP case 3 that was more complex. In the other two cases, the gap was reduced; however, UROs scored better than PCPs. PCPs in CIEF (n=23) had significantly higher SP case scores compared with non-CIEF PCPs (n=10); 216.6 vs 191.0, respectively (P=0.0437). PCPs in CIEF also showed a significantly greater level in mean attitude scores compared with UROs, 10.82 vs 8.15, respectively (P<0.0001). Both PCPs and UROs scored higher after participating in CIEF ED educational programs than those clinicians who participated in non-CIEF ED educational programs. In addition, clinicians participating in more CIEF programs scored higher than those participating in fewer CIEF programs. As expected, UROs consistently scored better than PCPs, indicating a higher baseline level of knowledge base about ED. However, this educational gap was significantly reduced in PCPs who participated in CIEF programs. The study demonstrated that PCPs who took more CIEF courses were almost as knowledgeable as UROs on the subject of ED. Longitudinal, disease-specific CME initiatives are valuable in that they positively impact the knowledge and thus the behavior of participating physicians, potentially conferring clinical benefits toward patient outcomes.

Validated questionnaires for assessing sexual dysfunction and BPH/LUTS: solidifying the common pathophysiologic link.

Erectile dysfunction (ED) and benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS) share many epidemiologic and clinical similarities. First-line therapy for both conditions include oral medications (alpha blockers, phosphodiesterase inhibitors). The impetus to develop and use questionnaires to characterize these two conditions is based on the trend away from invasive diagnostic testing to the use of patient-reported outcomes or validated self-administered questionnaires. The International Prostate Symptom Score, the International Index of Erectile Function, the Male Sexual Health Questionnaire (MSHQ) and the MSHQ short form are similar patient-reported assessment questionnaires used for research or clinical evaluation of BPH/LUTS, ED and ejaculatory dysfunction. These patient-based self-administered questionnaires are likely to assume an ever increasing important role in the future, as oral BPH therapies are considered for the treatment of ED and oral ED therapies are considered for the treatment of BPH/LUTS.

Response to treatment with tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline.

The purpose of this post hoc analysis was to evaluate response to tadalafil in patients with erectile dysfunction (ED) who reported failures in all sexual intercourse attempts before treatment. In a multicenter, open-label study, 1911 men received tadalafil 20 mg dosed as needed (up to once daily), for 12 weeks following a 4-week treatment-free run-in period. Efficacy measures included the sexual encounter profile (SEP) and the erectile function (EF) domain of the International Index of Erectile Function (IIEF-EF). Approximately, one-half (n=952, 49.9%) of the patients reported no successful intercourse attempts during the 4-week run-in period. Of these, 771 patients (81.0%) had at least one successful intercourse attempt during the treatment period. Furthermore, among responders, mean IIEF-EF scores at study end were similar regardless of success or no success at baseline. Patients who are unable to have successful intercourse should be encouraged to try oral phosphodiesterase type 5 inhibitor treatment for ED.

Benign prostatic hyperplasia evaluation, treatment and association with sexual dysfunction: practice patterns according to physician specialty.

AIMS: Lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are a common problem in ageing men and are accompanied by sexual dysfunction (SD) in 40-70% of men evaluated in large-scale epidemiological studies. One year after the 2003 American Urological Association (AUA) guideline on BPH management was published, a survey of US urologists (UROs) and primary care physicians (PCPs) was conducted to ascertain physician knowledge of the AUA guideline and practice patterns regarding LUTS/BPH diagnosis, treatment and association with SD. METHODS: A 19-question qualitative survey, sponsored by the American Foundation of Urologic Disease, was mailed April 2004 to 7500 UROs and 17,500 PCPs, with responses collected until May 2004. RESULTS: A total of 788 surveys were returned (437 UROs; 351 PCPs). Only 62% of PCPs were aware of and only 41% of PCPs used the AUA-Symptom Index/International Prostate Symptom Score (AUA-SI/IPSS) to assess LUTS compared with 97% and 81% of UROs respectively. Alpha-blocker monotherapy was the treatment of choice for both UROs and PCPs. Compared with UROs, PCPs reported higher rates of SD in association with LUTS or BPH (37% vs. 27%) and BPH pharmacotherapy (27% vs. 21%). UROs and PCPs reported higher rates of SD side effects [ejaculatory dysfunction (EjD) and erectile dysfunction (ED)] for tamsulosin (EjD: UROs 22%, PCPs 12%; ED: UROs 7%, PCPs 10%) and doxazosin (EjD: UROs 14%, PCPs 10%; ED: UROs 7%, PCPs 12%) than for alfuzosin (EjD: UROs 6%, PCPs 4%; ED: UROs 4%, PCPs 5%). CONCLUSIONS: The results suggest that many PCPs are not using the AUA-SI/IPSS to assess LUTS in their ageing male patients. Both UROs and PCPs appear to be underestimating the prevalence of SD in men with LUTS/BPH relative to prevalence rates reported in large-scale epidemiological studies.

The multinational Men's Attitudes to Life Events and Sexuality study: the influence of diabetes on self-reported erectile function, attitudes and treatment-seeking patterns in men with erectile dysfunction.

AIMS: To identify the prevalence of erectile dysfunction (ED) in men with diabetes, and to compare the perceptions of ED and the treatment-seeking behaviour of these men with men with ED without diabetes. METHODS: Phase I of this multinational study involved 27,839 men who were questioned about a number of men's health issues including ED, diabetes and cardiovascular conditions (i.e. hypertension, high cholesterol and angina). Epidemiological associations between these conditions were explored. Phase II involved 2912 men with self-reported ED, aged 20-75 years. Participants completed questionnaires concerning their ED, efforts to seek treatment for their ED, and potential influences that might affect treatment-seeking behaviour. Comparison of these responses was made between men with ED and diabetes and men with ED without diabetes. RESULTS: There was a clear association between self-reported ED and diabetes, hypertension, angina and high cholesterol. Men with diabetes were more likely to consider their ED to be severe and permanent and to speak to a physician or a nurse about their ED, compared with men without diabetes. Sildenafil use was similar in both groups, but men with diabetes were more likely to have discontinued use, mainly because of the lack of treatment efficacy. CONCLUSION: Men with diabetes were more likely to consider their ED to be severe and permanent, compared with men without diabetes. Furthermore, men with diabetes were more likely to discontinue sildenafil therapy, primarily because of poor efficacy. These findings suggest a need for alternative treatments for ED, especially in men with diabetes.

The Sexual Health Inventory for Men (SHIM): a 5-year review of research and clinical experience.

The Sexual Health Inventory for Men (SHIM) is a widely used scale for screening and diagnosis of erectile dysfunction (ED) and severity of ED in clinical practice and research. In reviewing the SHIM-related literature, we sought to provide a compendium of studies in which the SHIM was used, to provide a systematic framework for organizing and evaluating the studies, and to provide a status report on the SHIM and its impact on the management of male sexual dysfunction. Using a Medline search, we found that the SHIM was an integral measure in at least 21 studies on the prevalence of ED, 23 studies on the efficacy of ED interventions, and eight other (mainly correlational) studies. The quantity of research and quality of scholarship on the SHIM provide testimony to its positive impact on understanding and improving male sexual function. These scientific contributions are likely to remain influential in coming years.

Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra.

PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following subcutaneous administration to healthy male subjects and to patients with erectile dysfunction (ED) who report an inadequate response to Viagra. An inadequate response was defined for this study by patient report indicating that achievement of an erection suitable for vaginal penetration occurred < or =50% of the time while taking 100 mg Viagra. Erectile responses were assessed by RigiScan in healthy subjects in the absence of visual sexual stimulation (VSS) and in ED patients in the presence of VSS. Doses ranging from 0.3 to 10 mg were administered to healthy male subjects, resulting in a statistically significant erectile response at doses greater than 1.0 mg. ED patients were treated with placebo, 4 or 6 mg PT-141 in a crossover design in the presence of VSS. The erectile response induced by PT-141 was statistically significant at both doses. PT-141 was safe and well tolerated in both studies. The erectogenic potential of PT-141, its tolerability profile and its ability to cause significant erections in patients who do not have an adequate response to a PDE5 inhibitor suggest that PT-141 may provide an alternative treatment for ED with a potentially broad patient base.