Spontaneous erectile function recovery among young men with erectile dysfunction taking tadalafil 5 mg once a day.

BACKGROUND: Daily (once a day [OaD]) tadalafil intake is a valuable option for men favoring spontaneous over scheduled sexual intercourse. AIM: The study sought to assess the rate of and the clinical factors associated with spontaneous, medication-free erectile function (EF) recovery after discontinuation of tadalafil 5 mg OaD in a cohort of young men seeking first medical help for psychogenic erectile dysfunction (ED) as their primary complaint. METHODS: Data from 96 consecutive patients <50 years of age seeking first medical help for ED and prescribed tadalafil 5 mg OaD were analyzed. Patients completed the International Index of Erectile Function (IIEF) and underwent baseline penile color Doppler ultrasound. Follow-up involved clinical assessments or phone interviews. Spontaneous medication-free EF recovery was defined as IIEF EF domain score >22 after tadalafil discontinuation, prompting cessation of follow-up. Descriptive statistics compared tadalafil OaD responders and nonresponders. Cox regression hazard models explored the association between baseline characteristics and EF recovery risk post-drug discontinuation. Kaplan-Meier analyses estimated EF recovery probability over time. OUTCOMES: The primary outcome was EF recovery after discontinuation of tadalafil 5 mg OaD. RESULTS: Overall, median age was 39 (interquartile range [IQR], 32-45) years. Of all, 82 (85.4%) patients achieved EF recovery after tadalafil OaD discontinuation, while 14 (14.6%) patients were identified as nonresponders. Median tadalafil usage time (from beginning to discontinuation) was 3 (IQR, 2-11) months. The most common treatment-emergent adverse event was headache in 9 (9.4%) patients. Nonresponders were older (43 [IQR, 42-45] years vs 38 [IQR, 31-44] years; P = .03), had higher body mass index (25.5 [IQR, 23.4-29.9] kg/m2 vs 23.6 [IQR, 21.8-25.9] kg/m2; P = .04), and reported lower baseline IIEF EF domain scores (12 [IQR, 7-15] vs 15 [IQR, 10-22]; P = .02) than responders. Nonresponders and responders did not differ in terms of baseline ED severity, Charlson comorbidity index, smoking, alcohol consumption, regular physical exercise, and color Doppler ultrasound parameters. Upon Cox regression analysis, younger age (hazard ratio, 0.95; 95% confidence interval, 0.92-0.99; P = .01) was associated to EF recovery, after adjusting for baseline ED severity, body mass index, smoking, and Charlson comorbidity index ≥1. The Kaplan-Meier analysis displays the probability of EF recovery over time, indicating rates of 43%, 60%, and 72% at 3-, 6-, and 12-month follow-up intervals, respectively. CLINICAL IMPLICATIONS: Tadalafil 5 mg OaD is an effective short-term treatment for psychogenic ED, allowing its discontinuation after achieving a normal medication-free EF. STRENGTHS AND LIMITATIONS: The main limitations are the limited number of participants and the potential neglect of confounding factors. CONCLUSION: Almost 1 out of 2 young men with primary psychogenic ED who were prescribed with tadalafil 5 mg OaD recovered spontaneous medication-free EF after 3 months of treatment. Overall, the younger the patient was, the higher the chance there was of spontaneous EF recovery after drug discontinuation.

Patients' attitude with surgery for Peyronie's disease: results from a multicentric European study.

BACKGROUND: Despite the existence of conservative therapies for Peyronie's disease (PD), surgery is commonly utilized for the treatment of bothersome curvatures due to its potential effectiveness, although it carries intrinsic risks and may not universally lead to satisfactory outcomes. AIM: To explore the rate and factors influencing patients' willingness to undergo surgery for PD. METHODS: Data were prospectively collected in 5 European academic centers between 2016 and 2020. Data included age, time from PD onset, penile pain, curvature degree, difficulty at penetration, hourglass deformity, erectile dysfunction (ED), and previous treatments. All patients were offered conservative treatments, either medications or injections. Tunical shortening or lengthening procedures were offered as an alternative to conservative treatments, when indicated. Penile prosthesis was offered to those with concomitant ED. Patients' attitudes with surgery were recorded. Logistic regression analyses tested the profile of patients who were more likely to be willing to undergo surgery. OUTCOMES: Patients' willingness to undergo surgery for PD. RESULTS: This study included 343 patients with a median age of 57.3 years (IQR, 49.8-63.6) and a median penile curvature of 40.0° (IQR, 30.0°-65.0°). Overall, 161 (47%) experienced penetration difficulties and 134 (39%) reported ED. Additionally, hourglass deformity and penile shortening were reported by 48 (14%) and 157 (46%), respectively. As for previous treatments, 128 (37%) received tadalafil once daily; 54 (16%) and 44 (13%), intraplaque verapamil and collagenase injections; and 30 (9%), low-intensity shock wave therapy. Significant curvature reduction (≥20°) was observed in 69 (20%) cases. Only 126 (37%) patients were open to surgery for PD when suggested. At logistic regression analysis after adjusting for confounders, younger age (odds ratio [OR], 0.97; 95% CI, 0.95-1.00; P = .02), more severe curvatures (OR, 1.04; 95% CI, 1.03-1.06; P < .0001), and difficulty in penetration (OR, 1.88; 95% CI, 1.04-3.41; P = .03) were associated with a greater attitude to consider surgical treatment. CLINICAL IMPLICATIONS: The need for effective nonsurgical treatments for PD is crucial, as is comprehensive patient counseling regarding surgical risks and benefits, particularly to younger males with severe curvatures. STRENGTHS AND LIMITATIONS: Main limitations are the cross-sectional design and the potential neglect of confounding factors. CONCLUSIONS: Patients with PD, having a lower inclination toward surgery, emphasize the need for effective nonsurgical alternatives and accurate counseling on the risks and benefits of PD surgery, particularly for younger men with severe curvatures.

Cardiovascular Morbidity and Mortality in Men - Findings From a Meta-analysis on the Time-related Measure of Risk of Exogenous Testosterone.

BACKGROUND: In the context of established male hypogonadism, testosterone therapy (TTh) has been employed to regain physiologic levels of circulating testosterone and improve sexual function and overall quality of life. AIM: To assess the risk of cardiovascular disease and mortality as time-dependent outcomes in treated vs TTh untreated hypogonadal men. METHODS: A meta-analysis using weighted time-related measure of risk (hazard ratios (HRs)) for each of the outcome for all included studies was performed. Studies investigating male adults (≥18 years old) diagnosed with hypogonadism and divided into 2 arms (a treatment arm [any TTh] and a control arm [observation or placebo]) and assessing the risk of death and/or cardiovascular events were included. Single arm, non-comparative studies were excluded as well as studies that did not report the HRs for the chosen outcomes. This systemic review was registered on PROSPERO (CRD42022301592) and performed according to MOOSE and PRISMA guidelines. OUTCOMES: Overall mortality and cardiovascular events of any type. RESULTS: Overall, 10 studies were included in the meta-analysis, involving 179,631 hypogonadal men. Hypogonadal men treated with TTh were found to be at lower mortality risk from all causes relative to the control (observation or palcebo) arm (HR: 0.70; 95% Confidence Interval [CI]: 0.54-0.90; P < .01), whilst any unfavorable effect of TTh in hypogonadal men in terms of cardiovascular events compared to untreated/observed hypogonadal men was found (HR: 0.98; 95% CI 0.73-1.33; P = .89). CLINICAL IMPLICATIONS: TTh in hypogonadal men might play a role in reducing the overall risk of death without increasing cardiovascular events risk. STRENGTHS & LIMITATION: Main limitations are represented by the high heterogeneity among the studies in terms of included population, definition for hypogonadism, type of TTh, definition of cardio-vascular event used, and the length of follow-up. CONCLUSION: According to time-related measures of risk only, an increased risk of long-term morbidity and early mortality for untreated hypogonadal men was depicted, further outlining the clinical importance and safety of TTh in true hypogonadal men, with the urgent need of collecting long-term follow-up data. Fallara G, Pozzi E, Belladelli F, et al. Cardiovascular Morbidity and Mortality in Men - Findings From a Meta-analysis on the Time-related Measure of Risk of Exogenous Testosterone. J Sex Med 2022;19:1243-1254.

Longitudinal Impact of Social Restrictions on Sexual Health in the Italian Population.

BACKGROUND: Several trials have reported on the impact of social restrictions due to SARS-CoV-2 (COVID-19) pandemic on sexual function and psycho-physical well-being. However, data showing modifications of these outcomes over time and at the end of lock-down are scant. AIM: We investigated the longitudinal changes in sexual function during social restrictions for COVID-19 pandemic in Italy. METHODS: A web-based survey was administered to Italian citizens of legal age via social networks. The Beck Depression Inventory Primary Care, the General Health Survey, Female Sexual Function Index, International Index of Erectile Function, UCLA Loneliness Scale-version 3 questionnaires were used to test mental, physical and sexual well-being. The questionnaires were administered at the beginning of the lockdown (T0), 15 days from the first assessment (T1) and 1 month after the end of the restrictions in 2020 (T2). OUTCOMES: Descriptive statistics and multiple regression analysis were applied to investigate changes in sexual function over and at the end of social restrictions. RESULTS: Data were available for 2543 people (47.2% of men; 43.4% women; 9.4% undefined). Mean age was 48.3 ± 15.1 years for males and 43.9 ± 13.4 for females. Overall, 2.6% reported depressive symptoms according to Beck Depression Inventory Primary Care, 7.4% reported a high level of UCLA loneliness and 19.4% low levels of general mental health. Mild to severe erectile dysfunction was reported by 59.1% of men at T0, while 68.4% of women reported sexual dysfunction. Sexual function levels remain generally unchanged at further follow-up over the social restriction time period (T1), although those who were sexually active at baseline showed a decrease in sexual function scores. At T2, there was an overall improvement in sexual function scores with a rate of severe erectile dysfunction decreasing from 37.1% to 24.1% from T0 to T2 among males and a significant decrease of female sexual dysfunction from 68.4% to 51.2%. CLINICAL IMPLICATIONS: Young individuals and those with good mental and physical health were more likely to improve sexual function at the end of social restrictions. STRENGTHS & LIMITATIONS: Valid and reliable questionnaires and longitudinal approach design represent strengths; a large but convenient sample and lack of pre-pandemic baseline data represent limits. CONCLUSION: Social restrictions due to COVID-19 pandemic led to an increase in sexual dysfunctions in both genders. However, these conditions appeared temporary since an overall improvement was observed at the end of lockdown and especially in younger individuals with higher psycho-physical well-being. Vedovo F, Capogrosso P, Di Blas L, et al. Longitudinal Impact of Social Restrictions on Sexual Health in the Italian Population. J Sex Med 2022;19:923-932.

Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel.

BACKGROUND: Patients with prostate cancer suffer significant sexual dysfunction after treatment which negatively affects them and their partners psychologically, and strain their relationships. AIM: We convened an international panel with the aim of developing guidelines that will inform clinicians, patients and partners about the impact of prostate cancer therapies (PCT) on patients' and partners' sexual health, their relationships, and about biopsychosocial rehabilitation in prostate cancer (PC) survivorship. METHODS: The guidelines panel included international expert researchers and clinicians, and a guideline methodologist. A systematic review of the literature, using the Ovid MEDLINE, Scopus, CINAHL, PsychINFO, LGBT Life, and Embase databases was conducted (1995-2022) according to the Cochrane Handbook for Systematic Reviews of Interventions. Study selection was based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Each statement was assigned an evidence strength (A-C) and a recommendation level (strong, moderate, conditional) based on benefit/risk assessment, according to the nomenclature of the American Urological Association (AUA). Data synthesis included meta-analyses of studies deemed of sufficient quality (3), using A Measurement Tool to Assess Systematic Reviews (AMSTAR). OUTCOMES: Guidelines for sexual health care for patients with prostate cancer were developed, based on available evidence and the expertise of the international panel. RESULTS: The guidelines account for patients' cultural, ethnic, and racial diversity. They attend to the unique needs of individuals with diverse sexual orientations and gender identities. The guidelines are based on literature review, a theoretical model of sexual recovery after PCT, and 6 principles that promote clinician-initiated discussion of realistic expectations of sexual outcomes and mitigation of sexual side-effects through biopsychosocial rehabilitation. Forty-seven statements address the psychosexual, relationship, and functional domains in addition to statements on lifestyle modification, assessment, provider education, and systemic challenges to providing sexual health care in PC survivorship. CLINICAL IMPLICATIONS: The guidelines provide clinicians with a comprehensive approach to sexual health care for patients with prostate cancer. STRENGTHS & LIMITATIONS: The strength of the study is the comprehensive evaluation of existing evidence on sexual dysfunction and rehabilitation in prostate cancer that can, along with available expert knowledge, best undergird clinical practice. Limitation is the variation in the evidence supporting interventions and the lack of research on issues facing patients with prostate cancer in low and middle-income countries. CONCLUSION: The guidelines document the distressing sexual sequelae of PCT, provide evidence-based recommendations for sexual rehabilitation and outline areas for future research. Wittmann D, Mehta A, McCaughan E, et al. Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel. J Sex Med 2022;19:1655-1669.

Complete testicular remission after chemotherapy in a patient with advanced seminoma: is the testicle a real 'sanctuary'? A case report and review of the literature.

Testicular cancer is relatively uncommon, but at the same time, it is the most common solid tumor in men between the ages of 20 and 34 years. Seminoma represents the most frequently encountered germ cell tumors. Because orchiectomy is usually performed before chemotherapy, little is known about the effect of systemic chemotherapy on primary testicular tumors. Furthermore, the testis has always been considered a sanctuary site, an immune-privileged site in which inadequate exposure of the tumor to chemotherapy may occur. We report the case of a young patient with advanced seminoma with a complete testicular response after four cycles of cisplatin-based chemotherapy. Then, we performed a systematic review of the literature reporting the studies published to date on the topic.

The impact of asexual trait and porn addiction in a young men healthy cohort.

In the present study, we aimed to evaluate the association between asexual trait, erectile dysfunction (ED) and porn addiction in a community sample of young men. Between August 2019 and October 2019, a total of 559 young male adults were subjected to an online survey sponsored by social networks with the aim of assessing their sexual habits. The following questionnaires were administered: The International Index of Erectile Function (IIEF-5), Masturbation Erection index (MEI), Pornography Craving Questionnaire (PCQ) and Asexuality Identification Scale (AIS). The overall rate of ED according to IIEF-5 was 26.0% (165/478), the rate of ED according to MEI was 16.9% (81/478) and the rate ED in patients with AIS ≥23 indicating asexual trait was 10.0% (48/478). We found that IIEF-5 was positively associated with MEI (b = 0.32; p < .01) and negatively with AIS (b = -0.36; p < .01) and MEI was negatively associated with AIS (b = -0.36; p < .01). We found that MEI (odds ratio [OR]: 0.86; p < .01) and IIEF-5 (OR: 0.89; p < .01) were inversely associated with asexual trait. The presence of asexual trait can hide a greater risk of finding ED both in intercourse or masturbation. These results should be taken into consideration during the general assessment of the patient with sexual problems.

Normal sperm parameters per se do not reliably account for fertility: A case-control study in the real-life setting.

A proportion of men are infertile despite having normal medical history/physical examination and normal semen analysis. We aimed to assess whether normal sperm parameters per se account for male factor fertility. 1,957 infertile men were compared with 103 age-comparable fertile controls. Semen analysis was based on 2010 World Health Organization reference criteria. Of all, 12.1% of infertile men and 40.8% of fertile men presented with normal sperm parameters. Among fertile men, 36.9% had isolated sperm abnormalities and 22.3% men showed two or more concomitant sperm abnormalities. Serum total testosterone was higher in infertile men with normal sperm parameters compared to those with ≥2 sperm abnormalities or azoospermia, but similar to those with isolated sperm abnormalities (p ≤ .001). Circulating hormones were similar among sperm parameters groups in fertile men. At multivariable analyses, testicular volume (OR 1.12, p ≤ .001) and FSH (OR 0.8, p ≤ .001) were associated with normal sperm parameters. Overall, the longer the infertility period, the greater the number of sperm parameters abnormalities (p < .01). In conclusion, we found that 12% of infertile men and only 41% of fertile men present with normal sperm parameters. Normal sperm parameters per se do not reliably account for fertility in the real-life setting.

New Insight into Molecular and Hormonal Connection in Andrology.

Hormones and cytokines are known to regulate cellular functions in the testes. These biomolecules induce a broad spectrum of effects on various level of spermatogenesis, and among them is the modulation of cell junction restructuring between Sertoli cells and germ cells in the seminiferous epithelium. Cytokines and androgens are closely related, and both correct testicular development and the maintenance of spermatogenesis depend on their function. Cytokines also play a crucial role in the immune testicular system, activating and directing leucocytes across the endothelial barrier to the inflammatory site, as well as in increasing their adhesion to the vascular wall. The purpose of this review is to revise the most recent findings on molecular mechanisms that play a key role in male sexual function, focusing on three specific molecular patterns, namely, cytokines, miRNAs, and endothelial progenitor cells. Numerous reports on the interactions between the immune and endocrine systems can be found in the literature. However, there is not yet a multi-approach review of the literature underlying the role between molecular patterns and testicular and sexual function.

Erectile Recovery After Radical Pelvic Surgery: Methodological Challenges and Recommendations for Data Reporting.

INTRODUCTION: Erectile function (EF) outcomes after radical pelvic surgery vary widely among different studies, partly as a consequence of heterogeneity with regard to the data assessment and reporting methodology. AIM: Review the methodology of data assessment and reporting of studies evaluating EF outcomes after radical prostatectomy (RP), radical cystectomy (RC), and rectal surgery (RS) and provide detailed recommendations to conduct future high-quality research. METHODS: The MEDLINE database was searched for randomized clinical trials and open-label prospective or retrospective studies. MAIN OUTCOME MEASURE: The panel reviewed the modality of data assessment and reporting concerning 3 specific areas: preoperative patients assessment, surgical technique description, and postoperative patients management and follow-up. RESULTS: Overall, 280, 36, and 73 studies investigating EF after RP, RC, and RS, respectively, were included. Baseline EF was largely reported (88%) in studies on RP, but only 67% of the studies on either RC or RS assessed EF before surgery. Baseline comorbidities that could impact postoperative EF were reported in 62%, 64%, and 85% of studies on RP, RC, and RS, respectively. The type of surgical approach was provided in all studies, and surgical details relevant to EF (eg, nerve- or organ-sparing surgery) were reported by 86%, 81%, and 62% of studies on RP, RC, and RS, respectively. Conversely, surgeon experience was rarely reported across all studies. Validated tools were commonly used to assess postoperative EF (64% of studies for RP, 78% for RC, and 71% for RS). Only 41%, 17%, and 29% of studies on RP, RC, and RS, respectively, reported a follow-up of at least 2 years. Use of erectile dysfunction treatment after surgery was assessed by only 39%, 17%, and 4.1% of studies on RP, RC, and RS, respectively. Factors potentially influencing EF recovery (eg, urinary or fecal continence, urinary diversion) were commonly reported, but sexual desire after surgery was reported by only 18%, 42%, and 37% of studies on RP, RC, and RS, respectively. CLINICAL IMPLICATIONS: The use of a shared methodology for the assessment and reporting of data on EF outcomes after pelvic surgery would allow better estimation of EF outcomes after pelvic surgery. STRENGTHS & LIMITATIONS: The modality of data assessment and reporting among studies investigating EF outcome after pelvic surgery was systematically investigated to provide recommendations allowing a proper interpretation of data. CONCLUSION: Studies on EF outcomes after radical pelvic surgery should fulfill specific criteria concerning preoperative patient assessment, reporting of surgical details, and postoperative functional outcome evaluation and management. Capogrosso P, Pozzi EP, Celentano V, et al. Erectile Recovery After Radical Pelvic Surgery: Methodological Challenges and Recommendations for Data Reporting. J Sex Med 2020;17:7-16.

Longitudinal Risk of Developing Cardiovascular Diseases in Patients With Erectile Dysfunction-Which Patients Deserve More Attention?

BACKGROUND: Erectile dysfunction (ED) is widely considered as an early manifestation of cardiovascular diseases (CVDs), sharing similar risk factors. AIM: Assess rates and predictors of developing CVD and/or hypertension (HTN) over a long-term follow-up period using user-friendly and clinically reliable tools in men presenting with ED but without CVD/HTN or known vascular risk factors at baseline. METHODS: Data from 108 patients presenting between 2005 and 2011 with ED were analyzed. All patients were free from CVD and/or HTN (CVD/HTN) at baseline. Patients completed the International Index of Erectile Function (IIEF) at baseline and were followed up every 6 months with clinical assessment or phone interview. Kaplan-Meier analyses estimated the probability of developing CVD/HTN over time. Cox-regression models tested the association between patient baseline characteristics (for example, age, Charlson Comorbidity Index, baseline IIEF-EF, ED severity, alcohol intake, smoking), response to phosphodiesterase type-5 inhibitors (PDE5is), and the risk of developing CVD/HTN. RESULTS: Of all, 43 (40%) patients showed IIEF-EF scores suggestive of severe ED; 37 (39%) and 59 (61%) were nonresponders and responders to PDE5i, respectively. Median (interquartile range) age was 51 (41, 61) years. Median (interquartile range) follow-up was 95 (86-106) months. Overall, the estimated risk of developing CVD/HTN was 15% (95% confidence interval [CI]: 9-27) at 10-year assessment. Men with baseline severe ED had a higher risk of developing CVD/HTN (34%; 95% CI: 17-59, P = .03) at 10 years than patients with mild to moderate ED (5% [95% CI: 2-14]). At the Cox regression analysis, severe ED (Hazard ratio [HR], 4.62; 95% CI: 1.43, 8.89; P = .01) and baseline IIEF-EF score (HR, 0.92; 95% CI: 0.86, 0.99; P = .02) were associated to the risk of CVD/HTN overtime. Conversely, age and nonresponders to PDE5is (HR, 0.92; 95% CI: 0.32, 2.68; P = .9) were not associated to a risk of CVD/HTN over time. CLINICAL IMPLICATIONS: The use of an easy and user-friendly tool, as the IIEF-EF domain score, would allow to reliably assess which men with ED at first presentation may deserve a different, more specific and detailed cardiologic investigation to prevent inauspicious CV events. STRENGTHS & LIMITATIONS: A single-center-based, observational longitudinal study, raising the possibility of selection biases are the main limits. CONCLUSIONS: Patients with severe ED and lower baseline IIEF-EF but no vascular risk factors at first presentation have more than 30% risk of developing CVD/HTN in 10-year time. Those patients may benefit from medical preventive strategies to lowering the risk of CV events and HTN. Pozzi E, Capogrosso P, Boeri L, et al. Longitudinal Risk of Developing Cardiovascular Diseases in Patients With Erectile Dysfunction-Which Patients Deserve More Attention?. J Sex Med 2020;17:1489-1494.

Increased Use of Blood Transfusions to Manage Urological Conditions during the COVID-19 Pandemic.

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to an extensive reorganization of the healthcare system in Italy, with significant deferment of the treatment of urology patients. We aimed to assess the impact of deferred treatment during the SARS-CoV-2 pandemic on the need for blood transfusions in 3 Italian urology departments. METHODS: We reviewed hospital chart data on blood transfusions at the urology units of 3 academic centers in the north of Italy from March to April 2020. Data were compared with values from the same time frame in 2019 (March to April 2019). RESULTS: We observed significant reductions of the number of patients admitted to the urology units from March to April 2020 (373 vs. 119) and the number of performed surgeries (242 vs. 938) compared to 2019. Though, the number of transfused blood units was comparable between the 2 years (182 vs. 252), we found a greater mean number of blood units transfused per admission in 2020 (0.49 vs. 0.22; p < 0.0001). As a whole, the transfusion rate for hematuria was higher in 2020 than in 2019 (36 vs. 7.9%; p < 0.0001). DISCUSSION/CONCLUSION: The observed increased number of blood transfusions needed throughout the SARS-CoV-2 era could have had a negative impact on both patients and the healthcare system. It is possible to speculate that this is the consequence of a delayed diagnosis and deferred treatment of acute conditions.

High-risk human papillomavirus in semen is associated with poor sperm progressive motility and a high sperm DNA fragmentation index in infertile men.

STUDY QUESTION: Does the presence of human papillomavirus (HPV) in semen impact seminal parameters and sperm DNA quality in white European men seeking medical help for primary couple's infertility? SUMMARY ANSWER: HPV seminal infections involving high-risk (HR) genotypes are associated with impaired sperm progressive motility and sperm DNA fragmentation (SDF) values. WHAT IS KNOWN ALREADY: HPV is commonly present in semen samples. However, whether the presence of HPV in semen is actually associated with impaired sperm parameters and SDF values have yet to be elucidated. STUDY DESIGN, SIZE, DURATION: In this cross-sectional study, complete demographic, clinical and laboratory data from 729 infertile men were analysed. PARTICIPANTS/MATERIALS, SETTING, METHODS: Health-significant comorbidities were scored with the Charlson comorbidity index (CCI). Serum hormones and SDF index (measured by the sperm chromatin structure assay [SCSA]) were measured in every patient (SDF ≥30% was defined as pathological). Semen analysis was based on 2010 World Health Organisation reference criteria. Amplification by nested PCR was used to detect HPV-DNA sequences in semen samples. Descriptive statistics and linear regression models were used to test the association between the presence of HPV and clinical and seminal characteristics in the whole cohort. MAIN RESULTS AND THE ROLE OF CHANCE: The overall rate of HPV positivity was 15.5% (113/729). Overall, 78/729 (10.7%) and 35/729 (4.8%) patients had HR HPV+ and low-risk HPV+, respectively. HPV16 was the most prevalent type (22.1%), followed by HPV43 (10.6%), HPV56 and HPV42 (both 8.8%). No differences were found in terms of clinical and hormonal characteristics between patients with or without seminal HPV. Sperm progressive motility was significantly lower (P = 0.01) while SDF values were higher (P = 0.005) in HPV+ men compared to those with no HPV. In particular, HR HPV+ men had lower sperm progressive motility (P = 0.007) and higher SDF values (P = 0.003) than those with a negative HPV test. Univariable analysis showed that HR HPV+ was associated with impaired sperm progressive motility (P = 0.002) and SDF values (P = 0.003). In the multivariable analysis, age, FSH levels and testicular volume were significantly associated with impaired sperm progressive motility (all P ≤ 0.04). Conversely BMI, CCI, smoking habits and HPV status were not. Only age (P = 0.02) and FSH (P = 0.01) were significantly associated with SDF, after accounting for BMI, CCI, testicular volume, smoking habits and HPV status. LIMITATIONS, REASONS FOR CAUTION: Main limitations are the cross-sectional design of our study and the relatively small sample size of the subgroups. Additional limitations are the lack of a control group of normal fertile men and the lack of follow-up testing to check the clearance or the persistence of HPV in semen after a 6-12 months. WIDER IMPLICATIONS OF THE FINDINGS: Overall, these observations point out the importance of an accurate investigation of seminal HPV presence in everyday clinical practice in the diagnostic work-up of infertile men. STUDY FUNDING/COMPETING INTEREST(S): No external funding was used. There are no competing interests.

Satisfaction rate at 1-year follow-up in patients treated with penile implants: data from the multicentre prospective registry INSIST-ED.

OBJECTIVES: To investigate scores and predictors of patient satisfaction at 1 year after penile prosthesis implantation (PPI) using the validated Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire. PATIENTS AND METHODS: Analyses were performed for 142 patients prospectively included in the national multicentre registry Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction (INSIST-ED), which provided 1-year follow-up data. Postoperative patient satisfaction was assessed using the validated QoLSPP tool. Linear logistic regression analyses assessed predictors of QoLSPP total and single domain scores, including age at surgery, erectile dysfunction aetiology, type of prosthesis, surgical approach, surgeon experience and complications. Locally weighted regression methods were used to explore the relationship between surgeon experience and QoLSPP scores. RESULTS: Overall, high median functional, relational, social, personal and total QoLSPP scores were reported at 1 year after PPI. Patients implanted with hydraulic devices had higher functional (23 vs 21.5; P = 0.01) and total scores (68 vs 65.5; P = 0.03) than those with a malleable prosthesis. Surgeon experience emerged as the only independent predictor of higher satisfaction scores, depicting a non-linear association with both QoLSPP total and single domain scores (all P < 0.03). Data suggested that the higher the number of procedures per year, the greater the satisfaction scores, reaching a plateau after l5 procedures/year. CONCLUSIONS: This study reports high functional and patient satisfaction scores at 1 year after PPI surgery using a dedicated tool for the first time. Better outcomes should be expected for patients treated by surgeons with greater experience.

Undiagnosed prediabetes is highly prevalent in primary infertile men - results from a cross-sectional study.

OBJECTIVE: To study the prevalence and the risk associated with prediabetes (PreDM) in primary infertile men. PATIENTS AND METHODS: Data from 744 infertile men were analysed. Health-significant comorbidities were scored with the Charlson Comorbidity Index (CCI). Serum hormones were measured in every man. Semen analysis was based on 2010 World Health Organization (WHO) reference criteria. PreDM was defined according to the clinical criteria detailed by the American Diabetes Association (Diabetes Care 2014; 37 (Suppl. 1): S81). Descriptive statistics and logistic regression analyses tested the association between PreDM status, hormonal milieu and seminal parameters. The predictive accuracy of all variables was evaluated using the area under the curve, and the clinical net benefit estimated by decision curve analysis (DCA). RESULTS: Of the 744 men, PreDM was found in 114 (15.4%). Men with PreDM (+PreDM) were older, had higher CCI scores, lower total testosterone and sex hormone-binding globulin but higher follicle-stimulating hormone (FSH) and 17ß-oestradiol values compared to those without PreDM (-PreDM) (all P ≤ 0.04). Higher sperm DNA fragmentation index (DFI; P = 0.014) and idiopathic non-obstructive azoospermia (iNOA; P < 0.001) were found more frequently in +PreDM men. At multivariable logistic regression analysis, older age, FSH and iNOA (all P ≤ 0.04) were significantly associated with +PreDM status. DCA demonstrated a clinical net benefit in discriminating men at higher risk of a +PreDM status. CONCLUSIONS: About 15% of primary infertile men had criteria suggestive of undiagnosed PreDM. A PreDM status was associated with a greater risk of hypogonadism, higher DFI values and iNOA status. Age, FSH values and iNOA status could be considered as useful parameters to recognise men with PreDM and implement early preventive interventions in those men at risk of the consequences from poor glycaemic control.

The duration of infertility affects semen parameters in primary infertile men: results of a single-centre, cross-sectional study.

OBJECTIVE: To assess the relationship between the duration of infertility (DI) and the seminal parameters of a cohort of White-European primary infertile men. PATIENTS AND METHODS: Data from 1644 infertile men were analysed. Patients were grouped according to the self-reported DI into 12-month time frames. Semen analysis values were assessed based on 2010 World Health Organisation reference criteria. Descriptive statistics tested the difference in clinical, hormonal and seminal parameters between groups. Logistic regression models assessed the impact of DI on semen parameters. RESULTS: A DI of <12, 13-24, 25-36, 37-48, 49-60 and >60 months was found in 207 (12.6%), 651 (39.6%), 387 (23.5%), 168 (10.2%), 92 (5.6%) and 139 (8.4%) men, respectively. Patient's age (P < 0.001) and body mass index (P < 0.001) significantly increased along with DI. Hormonal values were similar across groups. Sperm concentration significantly decreased with DI (P = 0.01). Similarly, a higher rate of non-obstructive azoospermia (NOA) was more frequently found in men with a longer DI (P = 0.03). There were no differences in semen volume, sperm progressive motility, total motile sperm count (TMSC), and normal morphology across groups. Multivariable logistic regression analysis showed that DI was significantly associated with the risk of oligozoospermia (P < 0.001), TMSC <5 × 106 (P < 0.001), and NOA (P < 0.001). CONCLUSIONS: This cross-sectional study showed that DI had a negative impact on semen parameters in primary infertile men. Sperm concentration was negatively associated with DI and patients with a longer DI reported higher rates of azoospermia. Furthermore, DI was significantly associated with a higher risk of oligozoospermia, low TMSC, and NOA.

Long-Term Follow-Up After Penile Prosthesis Implantation-Survival and Quality of Life Outcomes.

INTRODUCTION: Hydraulic penile prostheses have shown an overall good mechanical reliability up to 10 years after surgery; however, few data have been published on very long-term follow-up. AIM: We looked at long-term (≥15 years) complications, including functional and quality of life (QoL) outcomes, after 3-piece inflatable penile prosthesis (IPP) implantation in patients with erectile dysfunction (ED). METHODS: Data regarding 149 patients submitting to IPP placement before 2001 were analyzed. All patients were implanted with AMS CX and Ultrex Plus 3-piece prostheses. MAIN OUTCOME MEASURE: Patients were reassessed to evaluate rates of complications and functional outcomes. The validated questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) was used to assess patient QoL. Kaplan-Meier analysis estimated the probability of prosthesis survival (defined as working device/not-explanted). RESULTS: Median follow-up of 51 patients was 206 months (interquartile range [IQR], 145-257). The etiology of ED was vasculogenic (n = 20; 39%), Peyronie's disease (n = 15; 29%), pelvic surgery (n = 4; 7.8%), organic other than vasculogenic (n = 3; 5.9%), or other (n = 9; 18%). Throughout the follow-up, 24 patients (49%) experienced complications: mechanical failure (n = 19; 79%), pain (n = 3; 12%), orgasmic dysfunctions (n = 1; 4.5%), or device infection (n = 1; 4.5%). The estimated IPP survival was 53% (95% CI, 36-67) at 20-year follow-up. Baseline characteristics (age, Charlson comorbidity index, body mass index, and erectile dysfunction etiology) were not significantly associated with the risk of IPP failure over time by Cox regression analysis. At 20-year follow-up, 41% (95% CI, 19-49) of the patients were still using the device. Among them, QoLSPP median domain scores were high: functional 22/25 (IQR, 20-23), relational 17/20 (IQR, 15-18), personal 14/15 (IQR, 12-15), and social 14/15 (IQR, 11-15). CLINICAL IMPLICATIONS: The longevity of the device and long-term satisfaction rates should be comprehensively discussed during patient consultation for IPP surgery. STRENGTHS & LIMITATIONS: To our knowledge, this is the first study reporting long-term QoL outcomes using a dedicated questionnaire for penile prostheses. The low response rate for the telephone interviews, the retrospective design of the study, and the relatively small number of patients are the main limitations. CONCLUSION: Long-term follow-up data after IPP placement showed that almost half of the devices still worked properly 20 years after the original penile implant, as 60% of patients were still using the device with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the expected life and outcomes of IPP implants. Chierigo F, Capogrosso P, Dehò, et al. Long-Term Follow-Up After Penile Prosthesis Implantation-Survival and Quality of Life Outcomes. J Sex Med 2019;16:1827-1833.

Should We Tailor the Clinical Management of Erectile Dysfunction According to Different Ages?

INTRODUCTION: The impact of erectile dysfunction (ED) on patients' sexual satisfaction and mood profile could differ across different ages. AIM: To investigate the relationship between erectile function (EF), sexual satisfaction, and mood status among patients seeking medical help for ED. METHODS: Data from 765 patients presenting at a single center for ED were analyzed. Patients were categorized as young (≤50 years), middle-aged (>50 and ≤65 years), and old (>65 years) individuals and completed the International Index of Erectile Function (IIEF) and the Beck's Inventory for Depression (BDI). MAIN OUTCOME MEASURES: The IIEF overall satisfaction and intercourse satisfaction domain scores and the BDI score were used to investigate sexual life satisfaction and depressive symptoms (defined as BDI > 11) across ages and according to ED severity. Linear and logistic regression analyses assessed the relationship between satisfaction scores and the risk of depressive symptoms with age and EF. RESULTS: Median (interquartile range) age at first assessment for ED was 50 (38, 59) years. Compared with older men, young and middle-aged patients showed significantly higher IIEF-OS and IIEF- Intercourse Satisfaction scores for increasing IIEF-EF scores. Older men showed no difference in terms of satisfaction scores for mild ED and normal EF status. At linear regression analysis, both IIEF-EF and age were significantly associated with sexual satisfaction (all P < .0001). The interaction term between age and EF was also significant, suggesting that the older the patients, the higher the feeling of sexual satisfaction for the same EF status (P = .004). Overall, 25% of patients reported depressive symptoms. Logistic regression analysis showed a 40% risk of depressive symptoms for patients <45 years with severe ED compared to a risk <20% for a man >65 years of age with the same EF status. CLINICAL IMPLICATIONS: Treating older patients with mild ED may not lead to a further improvement in sexual satisfaction as compared with younger patients with the same ED severity. Younger ED patients suffer more from depressive symptoms compared with older men, regardless of ED severity, thus supporting the need for a comprehensive psychological counseling. STRENGTH & LIMITATIONS: The single-center design and the lack of the assessment of the impact of ED treatment are the main limits. CONCLUSIONS: The clinical management of ED should be tailored according to different ages: younger patients deserve to be investigated and eventually treated for depressive symptoms. Older patients should be counseled for treatment when a sexual satisfaction improvement is expected. Capogrosso P, Ventimiglia E, Boeri L, et al. Should We Tailor the Clinical Management of Erectile Dysfunction According to Different Ages? J Sex Med 2019;16:999-1004.

Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM).

INTRODUCTION: Low-intensity shockwave therapy (LISWT) has been investigated for the treatment of uroandrological disorders including erectile dysfunction (ED), Peyronie's disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with controversial findings. AIM: To review the evidence on LISWT for ED, PD, and CP/CPPS and provide clinical recommendations on behalf of the European Society of Sexual Medicine. METHODS: Medline and Embase databases were searched for randomized clinical trials (RCTs), meta-analyses and open-label prospective or retrospective studies investigating the effect of LISWT on ED, PD, or CP/CPPS. OUTCOMES: The panel provided statements on clinically relevant questions concerning LISWT: (i) treatment efficacy, (ii) treatment protocol, (iii) clinical indications, and (iv) safety. The level of evidence was provided according to the Oxford 2011 criteria and graded using the Oxford Centre for Evidence-Based Medicine recommendations. RESULTS: 11 RCTs and 5 meta-analyses investigated LISWT for ED. RCTs provided controversial results on the efficacy of LISWT and were affected by high heterogeneity and the small number of patients included. Pooled-data analysis showed an overall positive effect in terms of erectile function improvement but reported small estimates and included a largely heterogeneous cohort of patients. 4 RCTs and 1 meta-analysis assessed LISWT for PD. All trials showed positive findings in terms of pain relief but no effect on penile curvature and plaque size. Inclusion criteria vary widely among studies, and further investigation is needed. 5 RCTs investigated LISWT for CP/CPPS. Data showed a possible effect on pain relief, although there is no evidence supporting that pain relief was maintained or any improvement in pain over time. CLINICAL IMPLICATIONS: LISWT needs to be further investigated in the context of sexual medicine and is almost but not yet ready for clinical practice. STRENGTHS AND LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. CONCLUSIONS: LISWT is a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation. Patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression. LISWT is not a primary treatment for CP/CPPS, but it may be considered as an option to relieve pain. Capogrosso P, Frey A, Jensen CFS, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490-1505.

Risk Based Surveillance after Surgical Treatment of Renal Cell Carcinoma.

PURPOSE: We assessed the accuracy of the UISS (UCLA Integrated Staging System) to predict the postoperative recurrence of renal cell carcinoma. We also evaluated whether including patient age and tumor histology would improve clinical decision making. MATERIALS AND METHODS: We analyzed the records of 1,630 patients treated with nephrectomy at a single academic center. The accuracy of the UISS model to predict early (12 months or less) and late (more than 60 months) recurrence after surgery was compared with a new model including patient age and disease histology. RESULTS: The new model and the UISS model showed high accuracy to predict early recurrence after surgery (AUC 0.84, 95% CI 0.81-0.88 and 0.83, 95% CI 0.80-0.87, respectively). In patients diagnosed with low risk tumor types (eg papillary type 1 and chromophobe lesions) the average risk of early recurrence significantly decreased in each UISS risk category when tumor histology was added to the predictive model (low risk 1.6% vs 0.6%, intermediate risk 5.5% vs 1.9% and high risk 45% vs 22%). Kaplan-Meier analysis showed no difference in the risk of late recurrence among the UISS risk categories. CONCLUSIONS: The UISS model should be applied to tailor the early followup protocol after nephrectomy. Patients with low risk histology deserve less stringent followup regardless of the UISS risk category. Our results do not support a risk stratification model to design a surveillance protocol after 5 years postoperatively.