Search

Objective To examine the safety and efficacy of using a clitoral vacuum suction device (CVSD) versus vibratory stimulation (V) to treat orgasmic dysfunction in women with multiple sclerosis (MS) or spinal cord injury (SCI). Design Randomized clinical trial. Setting Two academic medical centers. Participants Women (N=31) including 20 with MS and 11 with SCI. Intervention A 12-week trial of the use of a CVSD versus V. Main Outcome Measures Female Sexual Function Inventory (FSFI) and Female Sexual Distress Scale (FSDS). Results Twenty-three women (18 MS, 5 SCI) completed the study including 13 of 16 randomized to CVSD and 10 of 15 randomized to V. There was a statistically significant increase in total FSFI score ( P =.011), desire ( P =.009), arousal ( P =.009), lubrication ( P =.008), orgasm ( P =.012), and satisfaction ( P =.049), and a significant decrease in distress as measured by FSDS ( P =.020) in subjects using the CVSD. In subjects who used V, there was a statistically significant increase in the orgasm subscale of the FSFI ( P =.028). Subjects using the CVSD maintained improvements 4 weeks after treatment. Conclusions CVSD is safe and overall efficacious to treat female neurogenic sexual dysfunction related to MS and SCI. V is also safe and efficacious for female neurogenic orgasmic dysfunction; however, results were limited to the active treatment period. Because of ease of access and cost, clinicians can consider use of V for women with MS or SCI with orgasmic dysfunction. CVSD is recommended for women with multiple sexual dysfunctions or for whom V is ineffective. [ABSTRACT FROM AUTHOR]

There is a pressing global need for trained and competent mental health clinicians to deliver evidence-based psychological therapies to millions of trauma survivors in need of care. Three model, large-scale training programs were initiated a decade ago, one in the United Kingdom (U.K.), and two in the United States (U.S.), to disseminate high-quality, evidence-based psychological care to traumatized children and adults in need of assistance. Milestone contributions to implementation science have been made by each of these training programs, although limitations and challenges remain to be considered. In contrast, culturally adapted and simplified PTSD interventions and therapy training programs have also been developed and tested during the past decade, three of which show particular promise for broader implementation. These simplified but evidence-based interventions have been developed for use by lay counsellors or health technicians with minimal or no prior mental health training. Finally, a growing range of technology-based and technology-assisted training models for PTSD providers have also been developed and disseminated in the past decade. This trend is expected to accelerate as more providers become accustomed to acquiring clinical training in this modality or format, although significant barriers to technology-based training will need to be overcome. [ABSTRACT FROM AUTHOR]

Background The relationship between obesity and impairments in male sexual functioning is well documented. Relatively few studies have investigated changes in sexual functioning and sex hormones in men who achieve significant weight loss with bariatric surgery. The objective of this study was to assess changes in sexual functioning, sex hormones, and relevant psychosocial constructs in men who underwent bariatric surgery. Methods A prospective cohort study of 32 men from the Longitudinal Assessment of Bariatric Surgery-2 (LABS) investigation who underwent a Roux-en-Y gastric bypass (median body mass index [25th percentile, 75th percentile] 45.1 [42.0, 52.2]) and completed assessments between 2006 and 2012. Bariatric surgery was performed by a LABS-certified surgeon. Sexual functioning was assessed by the International Index of Erectile Functioning (IIEF). Hormones were assessed by blood assay. Quality of life (QoL), body image, depressive symptoms and marital adjustment were assessed by questionnaire. Results Men lost, on average, (95% confidence interval) 33.3% (36.1%, 30.5%) of initial weight at postoperative year 1, 33.6% (36.8%, 30.5%) at year 2, 31.0% (34.1%, 27.9%) at year 3, and 29.4% (32.7%, 26.2%) at year 4. Participants experienced significant increases in total testosterone ( P <.001) and sex hormone binding globulin (SHBG) ( P <.001) through postoperative year 4. Although men reported improvements in sexual functioning after surgery, these changes did not significantly differ from baseline, with the exception of overall satisfaction at postoperative year 3 ( P = .008). Participants reported significant improvements in physical domains of health-related quality of life (HRQoL), all domains of weight-related QOL, and body image, but not in the mental health domains of HRQoL or relationship satisfaction. Conclusions Men who lost approximately one third of their weight after Roux-en-Y gastric bypass experienced significant increases in total testosterone and SHBG. They did not, however, report significant improvements in sexual functioning, relationship satisfaction, or mental health domains of HRQoL. This pattern of results differs from that of women who have undergone bariatric surgery, who reported almost uniform improvements in sexual functioning and psychosocial status. [ABSTRACT FROM AUTHOR]

Abstract: Background: Many individuals with obesity are motivated to lose weight to improve weight-related co-morbidities or psychosocial functioning, including sexual functioning. Few studies have documented rates of sexual dysfunction in persons with obesity. This study investigated sexual functioning, sex hormones, and relevant psychosocial constructs in individuals with obesity who sought surgical and nonsurgical weight loss. Methods: One hundred forty-one bariatric surgery patients (median BMI [25th percentile, 75th percentile] 44.6 [41.4, 50.1]) and 109 individuals (BMI = 40.0 [38.0, 44.0]) who sought nonsurgical weight loss participated. Sexual functioning was assessed by the Female Sexual Function Index (FSFI) and the International Index of Erectile Function (IIEF). Hormones were assessed by blood assay. Quality of life, body image, depressive symptoms, and marital adjustment were assessed by validated questionnaires. Results: Fifty-one percent of women presenting for bariatric surgery reported a sexual dysfunction; 36% of men presenting for bariatric surgery reported erectile dysfunction (ED). This is in contrast to 41% of women who sought nonsurgical weight loss and reported a sexual dysfunction and 20% of men who sought nonsurgical weight loss and reported ED. These differences were not statistically significant. Sexual dysfunction was strongly associated with psychosocial distress in women; these relationships were less strong and less consistent among men. Sexual dysfunction was unrelated to sex hormones, except for sex hormone binding globulin (SHGB) in women. Conclusion: Women and men who present for bariatric surgery, compared with individuals who sought nonsurgical weight loss, were not significantly more likely to experience a sexual dysfunction. There were few differences in reproductive hormones and psychosocial constructs between candidates for bariatric surgery and individuals interested in nonsurgical weight loss. [Copyright &y& Elsevier]

Abstract: Background: Despite widespread adoption of the six-item erectile function (EF) domain of the International Index of Erectile Function (IIEF) as a clinical trial end point, there are currently no objective data on what constitutes a minimal clinically important difference (MCID) in the EF domain. Objective: Estimate the MCID for the IIEF EF domain. Design, setting, and participants: Anchor-based MCIDs were estimated using data from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials of the phosphodiesterase type 5 inhibitor (PDE5-I) tadalafil for 3345 patients treated for 12 wk. Measurements: The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7: “Over the past 4 weeks, when you attempted sexual intercourse how often was it satisfactory for you?” MCIDs were developed using analysis of variance (ANOVA)– and receiver operating characteristic (ROC)–based methods in a subset of studies (n =11) by comparing patients with and without minimal improvement (n =863). MCIDs were validated in the remaining six studies (n =377). Results and limitations: The ROC-based MCID for the EF domain was 4, with estimated sensitivity and specificity of 0.74 and 0.73, respectively. MCIDs varied significantly (p <0.0001) according to baseline ED severity (mild: 2; moderate: 5; severe: 7). MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region, ED etiology, and age group. MCIDs did not differ by age group, geographic region, or ED etiology. Current analyses were based on 17 clinical trials of tadalafil. Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies. Conclusions: The contextualization of treatment-related changes in terms of clinically relevant improvement is essential to understanding treatment efficacy, to interpreting results across studies, and to managing patients effectively. This analysis provides, for the first time, anchor-based estimates of MCIDs in the EF domain score of the IIEF. [Copyright &y& Elsevier]

Abstract: Dissemination of evidence-based treatments for PTSD has become an important focus of activity in the aftermath of recent terrorist attacks (e.g., London underground and U.S. 9/11 attacks), natural disasters (e.g., Indian Ocean tsunami and Hurricane Katrina), and wars (e.g., in Iraq and Afghanistan). This has become a high priority need for all mental health training and service delivery organizations. Researchers and educators have begun to examine clinician and client perceptions and preferences regarding PTSD treatment processes, and health care systems are organizing more comprehensive efforts at training and system change. As this evolution of services moves forward, effective dissemination should be a major focus of health policy research for the next decade or more. This review critically evaluates the PTSD-related research and emerging theory related to four major sets of variables that affect dissemination: (1) Practitioner factors, (2) Training methods, (3) The practice innovation(s) being disseminated; and (4) Organization or system factors. We evaluate findings from recent studies in light of emerging models of dissemination, and in the final section of the paper, we consider five broad topics with particular implications for dissemination of PTSD-specific treatments. They are: (1) The content of dissemination (i.e., which treatment protocols or intervention methods should be prioritized); (2) Strict adherence versus flexibility in the use of treatment manuals and the role of fidelity assessment; (3) The need for collaboration with user audiences; (4) The potential role of web-based technologies in increasing the effectiveness and efficiency of dissemination; and (5) Development of dissemination infrastructures within organizations. [Copyright &y& Elsevier]

Objectives: The severity of lower urinary tract symptoms (LUTS) has correlated with erectile dysfunction (ED) and ejaculatory dysfunction (EjD) in large-scale epidemiologic studies. ED and EjD are also side effects of some medical therapies for LUTS suggestive of benign prostatic hyperplasia (LUTS/BPH). These relationships were examined in a physician office-based population of men enrolled in the BPH Registry. Methods: Enrolled men with LUTS/BPH who completed the International Prostate Symptom Score (IPSS), IPSS bother question, 5-item International Index of Erectile Function, and the 3 ejaculatory function items of the Male Sexual Health Questionnaire-EjD short form at baseline were eligible. The relationship between sexual dysfunction and LUTS/BPH and BPH medical therapies were examined using multivariate analyses. Results: Of 6924 men enrolled, 5042 (mean age 65 years) completed all 4 baseline assessments. Of 3084 sexually active men, age, total IPSS, IPSS bother score, hypertension, diabetes, and black race/ethnicity were independent predictors of both ED and EjD (all P < .05). For the subset of 1362 men receiving BPH medical therapy, a significant association (P < .0001) was demonstrated for ED and EjD with specific BPH medical therapies. The α1A-subtype nonsuperselective quinazoline α1-blockers alfuzosin, doxazosin, and terazosin appeared to be associated with better ejaculatory function than were the α1A-subtype superselective sulfonamide α1-blocker tamsulosin, 5α-reductase inhibitors, and α1-blocker plus 5α-reductase inhibitor combination therapy. Conclusions: These results have provided additional evidence of the link between LUTS/BPH and sexual dysfunction in aging men and support clinical trial results indicating different rates of sexual side effects for BPH medical therapies. [Copyright &y& Elsevier]

Objectives: An abridged version of the 25-item Male Sexual Health Questionnaire (MSHQ) was developed and validated (MSHQ-EjD Short Form) for assessing ejaculatory dysfunction (EjD). Methods: The MSHQ was administered to 1245 men in the Men’s Sexual Health Population Survey, 179 gay/bisexual men in the Urban Men’s Health Study, and 6909 men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in the BPH Registry & Patient Survey. Factor analysis, scale reliability, construct and discriminant validity, and the correlation between the MSHQ-EjD Short Form and the MSHQ ejaculatory function domain were assessed. Results: Factor loadings of greater than 0.5 were demonstrated for four ejaculatory function items (force, volume, frequency, and delay). The force and volume of ejaculation had the greatest factor loadings (range 0.77 to 0.81), followed by frequency of ejaculation (0.64 and 0.66). These three ejaculatory function items had a high degree of internal consistency (Cronbach alpha ≥0.78) and test-retest reliability (r = 0.72). The three items discriminated between men with none/mild LUTS and those with moderate/severe LUTS (P <0.001). After adjusting for age, depression, and erectile function, the odds ratio for a diagnosis of moderate/severe LUTS was 0.68 (95% confidence interval 0.49 to 0.96; P <0.05). The three items had a correlation coefficient of 0.95 with the 7-item MSHQ ejaculatory function domain. The MSHQ ejaculation bother item, an independent domain, showed moderate correlation with the three ejaculatory function items (r = −0.41 and r = −0.45). Conclusions: The results of our study have shown that the MSHQ-EjD Short Form, with three ejaculatory function items and one ejaculation bother item, has excellent psychometric properties and should be a useful instrument for assessing EjD in clinical and research settings. [Copyright &y& Elsevier]

Abstract: As the incidence and prevalence of erectile dysfunction (ED) increase, healthcare providers will require robust, accurate, and efficient tools for appropriately diagnosing and treating patients with ED. Moreover, clinicians will need effective follow-up tools that assess treatment efficacy and satisfaction, to help patients meet their expectations for successful treatment of ED. We provide a summary of some of the most commonly used instruments for the diagnosis and assessment of ED treatment efficacy that will be referred to in this supplement. [Copyright &y& Elsevier]

The influence and significance of lifestyle factors in erectile dysfunction (ED) have been demonstrated in cross-sectional and prospective, randomized, controlled trials. Recent epidemiologic studies in several countries have shown that modifiable lifestyle or risk factors, including physical activity in particular, are directly related to the occurrence of ED. In this article, we review several recent observational studies, 2 of which include a longitudinal follow-up component in the study design. The levels of physical activity in both of these studies predicted ED prevalence and incidence. Furthermore, the role of lifestyle changes (weight loss, physical activity) were recently demonstrated to be effective in modifying ED in a prospective, randomized Italian trial in moderately obese, sedentary men. Men without overt diabetes mellitus or cardiovascular disease participated in this landmark study. Other studies have shown that aggressive management of cardiovascular risk factors can increase the effectiveness or outcomes associated with pharmacologic management of ED. Taken together, these studies support the value of risk factor modification and lifestyle change in the clinical management in men with ED and concomitant cardiovascular illness. [Copyright &y& Elsevier]

Abstract: Objectives: To validate a new, self-administered questionnaire for assessing key domains of sexual function and satisfaction in aging men with urogenital health concerns. Methods: The initial items were identified by patient interviews, review of current reports, and expert panel solicitation. The resulting 25-item questionnaire was subjected to psychometric evaluation and refinement using two discriminant validity studies in aging men with urogenital symptoms compared with age-matched controls. Psychometric tests of reliability, discriminant, and criterion validity were performed. Results: Qualitative testing revealed adequate comprehension and content validity of the initial item set. Two domains of sexual function (ejaculation, erection) were identified in the first discriminant validity study, each of which showed a high degree of internal consistency (alpha = 0.81 and alpha = 0.90, respectively) and test-retest reliability (r = 0.86 and r = 0.87, respectively). Both sexual function domains discriminated well between men with and without urogenital manifestations of lower urinary tract symptoms (LUTS) and sexual dysfunction (P <0.001). An additional domain of sexual satisfaction was added in the second validation study, with similarly high internal consistency (alpha = 0.90) and test-retest reliability (r = 0.88). Tests of convergent and divergent validity, including correlations with standardized scales for depression (Center for Epidemiologic Studies–Depressed Mood Scale), sexual function (International Index of Erectile Function), and life satisfaction (Fugl-Meyer), confirmed the criterion validity of the new measure. Conclusions: The Male Sexual Health Questionnaire assesses sexual function and satisfaction in older men with urogenital symptoms of LUTS and sexual dysfunction. This new instrument has excellent psychometric properties and is well suited for use in clinical and research settings. [Copyright &y& Elsevier]

Objectives: The Erection Quality Scale (EQS) is a new, self-report measure for assessing the quality of penile erections. It is intended to complement existing diagnostic and outcome measures (eg, International Index of Erectile Function, Sexual Encounter Profile) in both clinical practice and outcomes research in erectile dysfunction (ED).Methods: The initial phases of development and psychometric validation of the EQS are described. Specifically, qualitative research in patients and healthy men was used to generate relevant constructs. On the basis of the findings from these phases, and recommendations from an expert panel, seven constructs were selected for inclusion. Multiple items with different formats were drafted to measure each of the key constructs. An iterative process of cognitive testing, item revision, and item reduction was used to identify the 15 most appropriate items and their optimal response scales. This version of the scale was tested in a 200-subject discriminant validity study designed to gather data for a psychometric evaluation. Participants were classified into ED-untreated, ED-treated, and healthy control groups to evaluate the discriminant validity of the measure in men with different levels of erectile function.Results: The study results supported a robust single-factor structure, indicating that the EQS provides an overall index of erection quality. An intraclass correlation coefficient of 0.85 denotes adequate test-retest reliability. Furthermore, the EQS correlated well with existing measures and differentiated patients from the three ED classifications, a preliminary indication of discriminant validity.Conclusions: The findings presented provide evidence of the scale''s potential utility for measuring erection quality in future studies. [Copyright &y& Elsevier]

: ObjectiveIn some women, a decline in sexual interest accompanies a relative androgen insufficiency after menopause. We sought to characterize the hormonal effects of the combination of oral esterified estrogens and methyltestosterone and to investigate whether this regimen improves hypoactive sexual desire.: DesignDouble-blind randomized trial.: SettingHealthy volunteers in a multicenter research environment.: Patient(s)Postmenopausal women taking estrogen therapy who were experiencing hypoactive sexual desire.: Intervention(s)4 months of treatment with 0.625 mg of esterified estrogens (n = 111) or the combination of 0.625 mg of esterified estrogens and 1.25 mg of methyltestosterone (n = 107).: Main outcome measure(s)Baseline and end-of-study measurements of total and bioavailable testosterone and sex hormone–binding globulin (SHBG), and mean change in level of sexual interest or desire as rated on the Sexual Interest Questionnaire.: Result(s)Treatment with the combination of esterified estrogens and methyltestosterone significantly increased the concentration of bioavailable testosterone and suppressed SHBG. Scores measuring sexual interest or desire and frequency of desire increased from baseline with combination treatment and were significantly greater than those achieved with esterified estrogens alone. Treatment with the combination was well tolerated.: Conclusion(s)Increased circulating levels of unbound testosterone and suppression of SHBG provide a plausible hormonal explanation for the significantly improved sexual functioning in women receiving the combination of esterified estrogen and methyltestosterone. [Copyright &y& Elsevier]

Objective: To review validated methods for the assessment of female sexual function in clinical trials. Design: Evaluation of recent peer-review literature on sexual function assessment in women. Setting: International conference on androgen insufficiency in women. Patient(s): Women with sexual dysfunction due to androgen insufficiency or other causes. Intervention(s): None. Main Outcome Measure(s): Measures of sexual function in women. Result(s): Design and measurement problems in the assessment of sexual functioning in women have limited clinical trials in female sexual dysfunction. Objective measures, such as vaginal photoplethysmography or Duplex ultrasound, have been used in some studies but lack standardization and are unsuitable for use in large-scale clinical trials. A variety of interview methods, validated questionnaires, and event log measures have been used for assessing sexual function in recent trials of androgen replacement therapy. Each of these methods has distinct advantages and disadvantages, although validated questionnaires have provided the most reliable findings to date. Recent Food and Drug Administration guidelines on assessment of female sexual function in clinical trials are critically reviewed. Conclusion(s): Despite their prevalence and clinical significance, sexual problems in women have often been neglected in clinical trials. A major obstacle in the design of clinical trials in this area has been the need for sensitive and reliable measures of outcome. Of the currently available measures, self-reported event logs or questionnaires are best suited for research or clinical assessment of female sexual function. [ABSTRACT FROM AUTHOR]

In response to high suicide rates among veterans, the Department of Veterans Affairs (VA) has mandated that veterans at risk for suicide be given Safety Plans (SP). Research on the efficacy of SPs, however, is unclear and no prior study has examined the degree to which more personally relevant (i.e., higher quality) SPs may be associated with better outcomes or evaluate which components of SPs may be most effective at reducing suicidal behavior. The goal of the present study was to examine whether more personally relevant (i.e., higher quality) SPs reduce future suicide-related outcomes (psychiatric hospitalization, self-harm, and suicide attempts), and to determine which components of a SP may be most effective at reducing these outcomes. Participants were 68 individuals enrolled in a longitudinal national registry of returning military veterans receiving care from the VA, and who had at least one suicide-related event in the VA Suicide Prevention Applications Network. Data were collected between December 2009 and September 2016 and were analyzed between March 2016 and February 2017. Scores of SP quality were used to predict suicide-related outcomes. SP quality was low. Higher SP quality scores predicted a decreased likelihood of future suicide behavior reports (note entered into veteran's chart after a report of any self-harm behavior, including a suicide attempt). Higher scores on Step 3 (people and places that serve as distractions) predicted a decreased likelihood of future suicide behavior reports. More personally relevant SPs may reduce future suicide-related outcomes among veterans. Low SP quality scores highlight the need for training around SP implementation in the VA. [ABSTRACT FROM AUTHOR]

Background & Aims: The recommended therapy for chronic hepatitis C, pegylated interferon and ribavirin for 24 or 48 weeks, has many known adverse side effects. The aim of this study was to evaluate the impact of antiviral therapy on male sexual health. Methods: As part of the Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C), 260 men treated with pegylated interferon alfa-2a and ribavirin completed self-administered questionnaires concerning sexual desire, sexual function, including erectile and ejaculatory function, and sexual satisfaction before, during, and after treatment. Results: Before therapy, 37% of men reported at least some degree of impairment in sexual desire and 44% reported dissatisfaction with their sexual life, while 26% reported impairment in erectile and 22% in ejaculatory function. During therapy, significant declines were observed in all components of sexual health compared with pretreatment. At the end of therapy (24 or 48 weeks), an estimated 38%–48% of men reported that overall sexual function was worse than before treatment. African American patients reported less impairment in sexual desire and satisfaction than Caucasian American patients during therapy. By 24 weeks after treatment, sexual desire and satisfaction improved and were comparable to baseline levels. However, among men who received 48 weeks of therapy, the estimated percentage of men reporting posttreatment erectile or ejaculatory problems remained higher than baseline, although persistent erectile impairment was limited to Caucasian American patients. Conclusions: Sexual impairment is common among men with chronic hepatitis C undergoing therapy with pegylated interferon and ribavirin and should be considered as a potential side effect of antiviral therapy. [Copyright &y& Elsevier]

Context Robot-assisted surgery is increasingly used for radical cystectomy (RC) and urinary reconstruction. Sufficient data have accumulated to allow evidence-based consensus on key issues such as perioperative management, comparative effectiveness on surgical complications, and oncologic short- to midterm outcomes. Objective A 2-d conference of experts on RC and urinary reconstruction was organized in Pasadena, California, and the City of Hope Cancer Center in Duarte, California, to systematically review existing peer-reviewed literature on robot-assisted RC (RARC), extended lymphadenectomy, and urinary reconstruction. No commercial support was obtained for the conference. Evidence acquisition A systematic review of the literature was performed in agreement with the PRISMA statement. Evidence synthesis Systematic literature reviews and individual presentations were discussed, and consensus on all key issues was obtained. Most operative, intermediate-term oncologic, functional, and complication outcomes are similar between open RC (ORC) and RARC. RARC consistently results in less blood loss and a reduced need for transfusion during surgery. RARC generally requires longer operative time than ORC, particularly with intracorporeal reconstruction. Robotic assistance provides ergonomic value for surgeons. Surgeon experience and institutional volume strongly predict favorable outcomes for either open or robotic techniques. Conclusions RARC appears to be similar to ORC in terms of operative, pathologic, intermediate-term oncologic, complication, and most functional outcomes. RARC consistently results in less blood loss and a reduced need for transfusion during surgery. RARC can be more expensive than ORC, although high procedural volume may attenuate this difference. Patient summary Robot-assisted radical cystectomy (RARC) is an alternative to open surgery for patients with bladder cancer who require removal of their bladder and reconstruction of their urinary tract. RARC appears to be similar to open surgery for most important outcomes such as the rate of complications and intermediate-term cancer-specific survival. Although RARC has some ergonomic advantages for surgeons and may result in less blood loss during surgery, it is more time consuming and may be more expensive than open surgery. [ABSTRACT FROM AUTHOR]

Abstract: Context: Perioperative complications are a major surgical outcome for radical prostatectomy (RP). Objective: Evaluate complication rates following robot-assisted RP (RARP), risk factors for complications after RARP, and surgical techniques to improve complication rates after RARP. We also performed a cumulative analysis of all studies comparing RARP with retropubic RP (RRP) or laparoscopic RP (LRP) in terms of perioperative complications. Evidence acquisition: A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK). Evidence synthesis: We retrieved 110 papers evaluating oncologic outcomes following RARP. Overall mean operative time is 152min; mean blood loss is 166ml; mean transfusion rate is 2%; mean catheterization time is 6.3 d; and mean in-hospital stay is 1.9 d. The mean complication rate was 9%, with most of the complications being of low grade. Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are the most prevalent surgical complications. Blood loss (weighted mean difference: 582.77; p <0.00001) and transfusion rate (odds ratio [OR]: 7.55; p <0.00001) were lower in RARP than in RRP, whereas only transfusion rate (OR: 2.56; p =0.005) was lower in RARP than in LRP. All the other analyzed parameters were similar, regardless of the surgical approach. Conclusions: RARP can be performed routinely with a relatively small risk of complications. Surgical experience, clinical patient characteristics, and cancer characteristics may affect the risk of complications. Cumulative analyses demonstrated that blood loss and transfusion rates were significantly lower with RARP than with RRP, and transfusion rates were lower with RARP than with LRP, although all other features were similar regardless of the surgical approach. [Copyright &y& Elsevier]

Abstract: Context: Robot-assisted radical prostatectomy (RARP) was proposed to improve functional outcomes in comparison with retropubic radical prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). In the initial RARP series, 12-mo urinary continence recovery rates ranged from 84% to 97%. However, the few available studies comparing RARP with RRP or LRP published before 2008 did not permit any definitive conclusions about the superiority of any one of these techniques in terms of urinary continence recovery. Objective: The aims of this systematic review were (1) to evaluate the prevalence and risk factors for urinary incontinence after RARP, (2) to identify surgical techniques able to improve urinary continence recovery after RARP, and (3) to perform a cumulative analysis of all available studies comparing RARP versus RRP or LRP in terms of the urinary continence recovery rate. Evidence acquisition: A literature search was performed in August 2011 using the Medline, Embase, and Web of Science databases. The Medline search included only a free-text protocol using the term radical prostatectomy across the title and abstract fields of the records. The following limits were used: humans; gender (male); and publication date from January 1, 2008. Searches of the Embase and Web of Science databases used the same free-text protocol, keywords, and search period. Only comparative studies or clinical series including >100 cases reporting urinary continence outcomes were included in this review. Cumulative analysis was conducted using the Review Manager v.4.2 software designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK). Evidence synthesis: We analyzed 51 articles reporting urinary continence rates after RARP: 17 case series, 17 studies comparing different techniques in the context of RARP, 9 studies comparing RARP with RRP, and 8 studies comparing RARP with LRP. The 12-mo urinary incontinence rates ranged from 4% to 31%, with a mean value of 16% using a no pad definition. Considering a no pad or safety pad definition, the incidence ranged from 8% to 11%, with a mean value of 9%. Age, body mass index, comorbidity index, lower urinary tract symptoms, and prostate volume were the most relevant preoperative predictors of urinary incontinence after RARP. Only a few comparative studies evaluated the impact of different surgical techniques on urinary continence recovery after RARP. Posterior musculofascial reconstruction with or without anterior reconstruction was associated with a small advantage in urinary continence recovery 1 mo after RARP. Only complete reconstruction was associated with a significant advantage in urinary continence 3 mo after RARP (odds ratio [OR]: 0.76; p =0.04). Cumulative analyses showed a better 12-mo urinary continence recovery after RARP in comparison with RRP (OR: 1.53; p =0.03) or LRP (OR: 2.39; p =0.006). Conclusions: The prevalence of urinary incontinence after RARP is influenced by preoperative patient characteristics, surgeon experience, surgical technique, and methods used to collect and report data. Posterior musculofascial reconstruction seems to offer a slight advantage in terms of 1-mo urinary continence recovery. Update of a previous systematic review of literature shows, for the first time, a statistically significant advantage in favor of RARP in comparison with both RRP and LRP in terms of 12-mo urinary continence recovery. [Copyright &y& Elsevier]

Abstract: Context: Radical retropubic prostatectomy (RRP) has long been the most common surgical technique used to treat clinically localized prostate cancer (PCa). More recently, robot-assisted radical prostatectomy (RARP) has been gaining increasing acceptance among patients and urologists, and it has become the dominant technique in the United States despite a paucity of prospective studies or randomized trials supporting its superiority over RRP. Objective: A 2-d consensus conference of 17 world leaders in prostate cancer and radical prostatectomy was organized in Pasadena, California, and at the City of Hope Cancer Center, Duarte, California, under the auspices of the European Association of Urology Robotic Urology Section to systematically review the currently available data on RARP, to critically assess current surgical techniques, and to generate best practice recommendations to guide clinicians and related medical personnel. No commercial support was obtained for the conference. Evidence acquisition: A systematic review of the literature was performed in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Evidence synthesis: The results of the systematic literature review were reviewed, discussed, and refined over the 2-d conference. Key recommendations were generated using a Delphi consensus approach. RARP is associated with less blood loss and transfusion rates compared with RRP, and there appear to be minimal differences between the two approaches in terms of overall postoperative complications. Positive surgical margin rates are at least equivalent with RARP, but firm conclusions about biochemical recurrence and other oncologic end points are difficult to draw because the follow-up in existing studies is relatively short and the overall experience with RARP in locally advanced PCa is still limited. RARP may offer advantages in postoperative recovery of urinary continence and erectile function, although there are methodological limitations in most studies to date and a need for well-controlled comparative outcomes studies of radical prostatectomy surgery following best practice guidelines. Surgeon experience and institutional volume of procedures strongly predict better outcomes in all relevant domains. Conclusions: Available evidence suggests that RARP is a valuable therapeutic option for clinically localized PCa. Further research is needed to clarify the actual role of RARP in patients with locally advanced disease. [Copyright &y& Elsevier]

Although erectile dysfunction (ED) is considered a well-established risk factor for cardiovascular disease (CVD), few studies have investigated whether other aspects of sexual function might predict CVD independently of ED. In a longitudinal, population-based study of community-dwelling men participating in the Massachusetts Male Aging Study, we examined sexual function variables (including ED) and the subsequent development of CVD. ED was defined according to a validated, discriminant-analytic formula determined from the questionnaire responses and categorized as moderate/complete ED versus none/minimal. CVD included a wide range of major end points and was ascertained through self-report, medical records, and the National Death Index. We calculated the age-adjusted incidence rates according to the person-years of follow-up, and Cox proportional hazards models were used to estimate covariate-adjusted, Framingham risk score-adjusted, and ED-adjusted hazard ratios and 95% confidence intervals for sexual function variables and the subsequent risk of CVD. Of the 1,165 men free of CVD at baseline, the age-adjusted CVD incidence rate for moderate/complete ED and none/minimal ED was 17.9/1,000 person-years and 12.5/1,000 person-years, respectively. In multivariate models adjusted for age, covariates, ED, and the Framingham risk score, a low frequency of sexual activity (once a month or less vs ≥2 times weekly) was associated with increased risk of CVD (hazard ratio 1.45, 95% confidence interval 1.04 to 2.01). In conclusion, our results suggest that a low frequency of sexual activity predicts CVD independently of ED and that screening for sexual activity might be clinically useful. [Copyright &y& Elsevier]

Although knowledge of the neurophysiology and neuropharmacology of ejaculation has increased in the last decade, our understanding of the pathophysiology of the different types of ejaculatory dysfunction (EjD) remains limited. Epidemiological studies provide strong evidence of a relationship between lower urinary tract symptoms (LUTS) and EjD in aging men. Clinical trial results indicate that treatments for LUTS suggestive of benign prostatic hyperplasia (BPH) can be associated with EjD side effects. The present article provides an overview of current knowledge on the physiology of ejaculation, possible common pathophysiologic mechanisms for EjD and LUTS, with a focus on LUTS/BPH, and the effects of different BPH treatments on ejaculation. [Copyright &y& Elsevier]

Abstract: Objectives: This study evaluated the associated comorbidities and patient satisfaction with treatment options for premature ejaculation (PE), a common sexual dysfunction. Methods: A comprehensive, Internet-based survey (the PE Prevalence and Attitudes [PEPA] survey) was conducted among men ages 18–70 in the United States, Germany, and Italy (n =12,133). Men were classified as having PE based on self-report of low or absent control over ejaculation, resulting in distress for them or their sexual partner or both. Results: The prevalence of PE was 22.7% (24.0% in the United States, 20.3% in Germany, and 20.0% in Italy) and did not vary significantly with age among men over age 24 yr. Men with PE were more likely to self-report other sexual dysfunctions (e.g., anorgasmia, low libido, erectile dysfunction) and psychological disturbances (e.g., depression, anxiety, excessive stress) than men without PE (p <0.05 for all). Men with PE were most aware of (>70%) and most likely to have used (>50%) special positions during sex, interrupted stimulation, masturbation, and having intercourse more often than usual to manage their PE. Only 9.0% of men with PE reported having consulted a physician for the condition; 81.9% had to initiate the conversation about PE and 91.5% reported little or no improvement as a result of seeking treatment. Conclusion: PE is a highly prevalent sexual problem, with significant sexual and psychological comorbidities. Most men with PE do not seek assistance from their physician, and most of those who do are not satisfied with the results. [Copyright &y& Elsevier]

Recent studies have highlighted the relation between erectile dysfunction (ED) and cardiovascular disease. In particular, the role of endothelial dysfunction and nitric oxide in ED and atherosclerotic disease has been elucidated. Given the large number of men receiving medical treatment for ED, concerns regarding the risk for sexual activity triggering acute cardiovascular events and potential risks of adverse or unanticipated drug interactions need to be addressed. A risk stratification algorithm was developed by the First Princeton Consensus Panel to evaluate the degree of cardiovascular risk associated with sexual activity for men with varying degrees of cardiovascular disease. Patients were assigned to 3 categories: low, intermediate (including those requiring further evaluation), and high risk. This consensus study from the Second Princeton Consensus Conference corroborates and clarifies the algorithm and emphasizes the importance of risk factor evaluation and management for all patients with ED. The panel reviewed recent safety and drug interaction data for 3 phosphodiesterase (PDE)-5 inhibitors (sildenafil, tadalafil, vardenafil), with emphasis on the safety of these agents in men with ED and concomitant cardiovascular disease. Increasing evidence supports the role of lifestyle intervention in ED, specifically weight loss and increased physical activity, particularly in patients with ED and concomitant cardiovascular disease. Special management recommendations for patients taking PDE-5 inhibitors who present at the emergency department and other emergency medical situations are described. Finally, further research on the role of PDE-5 inhibition in treating patients with other medical or cardiovascular disorders is recommended. [Copyright &y& Elsevier]

Highlights • Relations between PTSD symptom clusters and PTSD symptoms were examined with respect to general distress and physiological arousal. • Each PTSD symptom cluster and 17 of 20 individual PTSD symptoms were more strongly associated with general distress than with physiological arousal. • Yet, moderate to strong associations were also found between physiological arousal and both PTSD clusters and symptoms. • Findings are not fully consistent with either of two prominent models of the position of PTSD with respect to external domains of psychopathology. Abstract Background The primary purpose of this study was to examine the place of posttraumatic stress disorder (PTSD) vis-à-vis the external dimensions of general distress and physiological arousal. Methods Using data collected from veterans of the wars in Iraq and Afghanistan (N = 1350), latent variable covariance structure modeling was employed to compare correlations of PTSD symptom clusters and individual PTSD symptoms with general distress and physiological arousal. Results Each PTSD symptom cluster, and 17 of 20 individual PTSD symptoms were more strongly associated with general distress than with physiological arousal. However, moderate to strong associations were also found between physiological arousal and both PTSD clusters and symptoms. Limitations Findings are based on self-reported data elicited from a single sample of veterans with substantial PTSD symptoms. Replication, particularly by clinician interview, is necessary. Generalizability to other traumatized populations is unknown. Conclusions Results offer support, with caveats, for viewing PTSD as a distress disorder. Findings are not consistent with the position that PTSD is a hybrid disorder with some features reflecting hyperarousal and others indicative of general distress. Results have implications for the conceptualization and measurement of PTSD. [ABSTRACT FROM AUTHOR]

Objective: To establish a descriptive profile of men with coexistent erectile dysfunction (ED) and/or benign prostatic hyperplasia (BPH), ED only or BPH only compared to those with neither condition and to identify the determinants of coexisting disease.Materials and Methods: Self-report and/or medication use measures defining ED and BPH were assessed in men aged ≥40 years (N = 2142) between 2001 and 2004 using the National Health and Nutrition Examination Surveys. Descriptive analyses examined the ED and/or BPH covariate distribution. Logistic regressions calculated odds ratios (ORs, 95% confidence interval) comparing men with ED and/or BPH, BPH only, or ED only to men with neither condition.Results: Of 393 men with BPH, 57.8% had coexistent ED, confirming the moderately strong co-occurrence of the conditions (P <.0001). Coexisting ED and/or BPH occurred in 10.6% of participants, whereas 24.4% and 7.7% reported ED and BPH. After age 60, the odds of reporting ED, BPH, or ED/BPH vs neither almost tripled per decade of increasing age, corresponding to prevalence increases. The unadjusted odds of ED and/or BPH vs no disease increased 1.3 times per prostate-specific antigen unit (ng/mL) increase and 1.1 times per C-reactive protein unit (mg/dL) increase. Other predisposing factors for ED and/or BPH included higher body mass index (OR = 2.5), increased antidiabetic (OR = 2.9) or proton pump inhibitor use (OR = 2.3), increased healthcare visits (≥4; OR = 3.5), and more frequent urinary voiding difficulties (OR = 9.7).Conclusion: Co-occurring ED and/or BPH is evident in ~10% of men ≥40 years old and is associated with significant clinical correlates. Clinicians need to pay greater attention to this clinically important syndrome in aging men. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the clinical usefulness of the Peyronie's Disease Questionnaire (PDQ). The relationship between subject-reported changes in PDQ psychosexual symptoms and clinical response to Peyronie's disease (PD) treatment was examined.Materials and Methods: Combined data from the collagenase Clostridium histolyticum phase 3 study program, IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II, were examined. Changes in the PDQ PD symptom bother, psychological and physical symptoms, and penile pain were examined relative to changes in the penile curvature deformity, including penile curvature absolute mean and percent change. PDQ changes relative to sexual function, including International Index of Erectile Function overall satisfaction and erectile function domains, and treatment responder status, including global assessment of PD and composite responder status, were also assessed. Individual PDQ questions were examined to provide a clinical perspective on the change in psychosexual symptoms experienced by men with PD during treatment.Results: Improvement in PDQ PD symptom bother and psychological and physical symptoms was significantly correlated with clinical improvement in penile curvature deformity (P ≤.0008) and sexual function (P <.0001). Significant differences in PD symptom bother and psychological and physical symptoms improvement were found between treatment responders vs nonresponders (P <.02). PDQ penile pain improvement among subjects reporting baseline pain ≥4 was significantly correlated with clinical improvement in sexual function (P ≤.0004) and was found to be greater in treatment responders vs nonresponders (P = .003).Conclusion: The utility of the PDQ for monitoring PD-specific psychosexual symptom severity, progression, and treatment response, both clinically and in trials of men with PD, was supported. [ABSTRACT FROM AUTHOR]

Background Nocturia is a chronic, fluctuating disease that disrupts sleep and has a wide-ranging impact on quality of life. Valid tools to measure the patient-reported impact of nocturia are essential for evaluating the value of treatment, but the available tools are suboptimal. Objectives This study reports the development and validation of the Nocturia Impact Diary—an augmented form of the Nocturia Quality of Life questionnaire designed to be completed in conjunction with the widely used 3-day voiding diary. Methods The process comprised three steps: Step 1: Development of a concept pool using the Nocturia Quality of Life questionnaire and data from relevant studies; Step 2: Content validity study; Step 3: Psychometric testing of construct validity, reliability, and sensitivity of the diary in a randomized, placebo-controlled study in patients with nocturia. Results Step 1: Fourteen items and 4 domains were included in the first draft of the diary. Step 2: Twenty-three patients with nocturia participated in the cognitive debriefing study. Items were adjusted accordingly, and the content validity was high. Step 3: Fifty-six patients were randomized to desmopressin orally disintegrating tablet or placebo. The diary demonstrated high construct validity, with good sensitivity and a good fit to Rasch model, as well as high internal consistency, discriminatory ability, and acceptable sensitivity to change. Results indicated that the diary was unidimensional. Conclusions The Nocturia Impact Diary is a convenient, validated patient-reported outcome measure. It should be used in conjunction with a voiding diary to capture the real-life consequences of nocturia and its treatment. [ABSTRACT FROM AUTHOR]

Objective: To determine the prevalence and correlates of lower urinary tract symptoms (LUTS) among returned Iraq and Afghanistan veterans; in particular its association with mental health diagnoses and medication use. Methods: We performed a retrospective cohort study of Iraq and Afghanistan veterans who were new users of U.S. Department of Veterans Affairs health care. Mental health diagnoses were defined by International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM) codes from medical records. LUTS was defined by ICD-9-CM code, use of prescription medication for LUTS, or procedure for LUTS. We determined the independent association of mental health diagnoses and LUTS after adjusting for sociodemographic and military service characteristics, comorbidities, and medications. Results: Of 519,189 veterans, 88% were men and the mean age was 31.8 years (standard deviation ± 9.3). The overall prevalence of LUTS was 2.2% (11,237/519,189). Veterans with post-traumatic stress disorder (PTSD) were significantly more likely to have a LUTS diagnosis, prescription, or related procedure (3.5%) compared with veterans with no mental health diagnoses (1.3%) or a mental health diagnosis other than PTSD (3.1%, P <.001). In adjusted models, LUTS was significantly more common in veterans with PTSD with and without other mental health disorders vs those without mental health disorders (adjusted relative risk [ARR] = 2.04, 95% confidence interval [CI] = 1.94-2.15) and in veterans prescribed opioids (ARR = 2.46, 95% CI = 2.36-2.56). Conclusion: In this study of young returned veterans, mental health diagnoses and prescription for opioids were independently associated with increased risk of receiving a diagnosis, treatment, or procedure for LUTS. Provider awareness may improve the detection and treatment of LUTS, and improve patient care and quality of life. [ABSTRACT FROM AUTHOR]

Abstract: Context: Despite the large diffusion of robot-assisted radical prostatectomy (RARP), literature and data on the oncologic outcome of RARP are limited. Objective: Evaluate lymph node yield, positive surgical margins (PSMs), use of adjuvant therapy, and biochemical recurrence (BCR)–free survival following RARP and perform a cumulative analysis of all studies comparing the oncologic outcomes of RARP and retropubic radical prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). Evidence acquisition: A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK) and Stata 11.0 SE software (StataCorp, College Station, TX, USA). Evidence synthesis: We retrieved 79 papers evaluating oncologic outcomes following RARP. The mean PSM rate was 15% in all comers and 9% in pathologically localized cancers, with some tumor characteristics being the most relevant predictors of PSMs. Several surgeon-related characteristics or procedure-related issues may play a major role in PSM rates. With regard to BCR, the very few papers with a follow-up duration >5 yr demonstrated 7-yr BCR-free survival estimates of approximately 80%. Finally, all the cumulative analyses comparing RARP with RRP and comparing RARP with LRP demonstrated similar overall PSM rates (RARP vs RRP: odds ratio [OR]: 1.21; p =0.19; RARP vs LRP: OR: 1.12; p =0.47), pT2 PSM rates (RARP vs RRP: OR: 1.25; p =0.31; RARP vs LRP: OR: 0.99; p =0.97), and BCR-free survival estimates (RARP vs RRP: hazard ratio [HR]: 0.9; p =0.526; RARP vs LRP: HR: 0.5; p =0.141), regardless of the surgical approach. Conclusions: PSM rates are similar following RARP, RRP, and LRP. The few data available on BCR from high-volume centers are promising, but definitive comparisons with RRP or LRP are not currently possible. Finally, significant data on cancer-specific mortality are not currently available. [Copyright &y& Elsevier]