Global Practice Patterns and Variations in the Medical and Surgical Management of Non-Obstructive Azoospermia: Results of a World-Wide Survey, Guidelines and Expert Recommendations.

PURPOSE: Non-obstructive azoospermia (NOA) is a common, but complex problem, with multiple therapeutic options and a lack of clear guidelines. Hence, there is considerable controversy and marked variation in the management of NOA. This survey evaluates contemporary global practices related to medical and surgical management for patients with NOA. MATERIALS AND METHODS: A 56-question online survey covering various aspects of the evaluation and management of NOA was sent to specialists around the globe. This paper analyzes the results of the second half of the survey dealing with the management of NOA. Results have been compared to current guidelines, and expert recommendations have been provided using a Delphi process. RESULTS: Participants from 49 countries submitted 336 valid responses. Hormonal therapy for 3 to 6 months was suggested before surgical sperm retrieval (SSR) by 29.6% and 23.6% of participants for normogonadotropic hypogonadism and hypergonadotropic hypogonadism respectively. The SSR rate was reported as 50.0% by 26.0% to 50.0% of participants. Interestingly, 46.0% reported successful SSR in <10% of men with Klinefelter syndrome and 41.3% routinely recommended preimplantation genetic testing. Varicocele repair prior to SSR is recommended by 57.7%. Half of the respondents (57.4%) reported using ultrasound to identify the most vascularized areas in the testis for SSR. One-third proceed directly to microdissection testicular sperm extraction (mTESE) in every case of NOA while others use a staged approach. After a failed conventional TESE, 23.8% wait for 3 months, while 33.1% wait for 6 months before proceeding to mTESE. The cut-off of follicle-stimulating hormone for positive SSR was reported to be 12-19 IU/mL by 22.5% of participants and 20-40 IU/mL by 27.8%, while 31.8% reported no upper limit. CONCLUSIONS: This is the largest survey to date on the real-world medical and surgical management of NOA by reproductive experts. It demonstrates a diverse practice pattern and highlights the need for evidence-based international consensus guidelines.

Global Practice Patterns in the Evaluation of Non-Obstructive Azoospermia: Results of a World-Wide Survey and Expert Recommendations.

PURPOSE: Non-obstructive azoospermia (NOA) represents the persistent absence of sperm in ejaculate without obstruction, stemming from diverse disease processes. This survey explores global practices in NOA diagnosis, comparing them with guidelines and offering expert recommendations. MATERIALS AND METHODS: A 56-item questionnaire survey on NOA diagnosis and management was conducted globally from July to September 2022. This paper focuses on part 1, evaluating NOA diagnosis. Data from 367 participants across 49 countries were analyzed descriptively, with a Delphi process used for expert recommendations. RESULTS: Of 336 eligible responses, most participants were experienced attending physicians (70.93%). To diagnose azoospermia definitively, 81.7% requested two semen samples. Commonly ordered hormone tests included serum follicle-stimulating hormone (FSH) (97.0%), total testosterone (92.9%), and luteinizing hormone (86.9%). Genetic testing was requested by 66.6%, with karyotype analysis (86.2%) and Y chromosome microdeletions (88.3%) prevalent. Diagnostic testicular biopsy, distinguishing obstructive azoospermia (OA) from NOA, was not performed by 45.1%, while 34.6% did it selectively. Differentiation relied on physical examination (76.1%), serum hormone profiles (69.6%), and semen tests (68.1%). Expectations of finding sperm surgically were higher in men with normal FSH, larger testes, and a history of sperm in ejaculate. CONCLUSIONS: This expert survey, encompassing 367 participants from 49 countries, unveils congruence with recommended guidelines in NOA diagnosis. However, noteworthy disparities in practices suggest a need for evidence-based, international consensus guidelines to standardize NOA evaluation, addressing existing gaps in professional recommendations.

Effects of Varicocele Repair on Sperm DNA Fragmentation and Seminal Malondialdehyde Levels in Infertile Men with Clinical Varicocele: A Systematic Review and Meta-Analysis.

PURPOSE: Varicoceles can be a source of elevated seminal oxidative stress (OS) and sperm DNA fragmentation (SDF). However, it remains unclear whether varicocele repair (VR) could reduce these parameters. This systematic review and meta-analysis (SRMA) aims to investigate the impact of VR on SDF and seminal malondialdehyde (MDA). MATERIALS AND METHODS: A literature search was performed in Scopus, PubMed, Ovid, Embase, and Cochrane databases. This SRMA included randomized controlled trials and observational studies reporting the pre- and postoperative levels of SDF and seminal OS in infertile men with clinical varicocele that underwent VR. Subgroup analyses included techniques of VR and SDF testing. The effect size was expressed as standardized mean difference (SMD). RESULTS: Out of 1,632 abstracts assessed for eligibility, 29 studies with 1,491 infertile men were included. The analysis showed a significant reduction in SDF after VR, compared to preoperative values (SMD -1.125, 95% confidence interval [CI] -1.410, -0.840; p<0.0001) with high inter-study heterogeneity (I²=90.965%). Reduction in SDF was evident with microsurgical technique and non-microsurgical inguinal approaches (SMD -1.014, 95% CI -1.263, -0.765; p<0.0001, and SMD -1.495, 95% CI -2.116, -0.873; p<0.0001), respectively. Reduction in SDF was significant irrespective of testing was done by sperm chromatin dispersion (SMD -2.197, 95% CI -3.187, -1.207; p<0.0001), sperm chromatin structure assay (SMD -0.857, 95% CI -1.156, -0.559; p<0.0001) or TUNEL (SMD -1.599, 95% CI -2.478, -0.719; p<0.0001). A significant decrease in seminal MDA levels was observed following VR (SMD -2.450, 95% CI -3.903 to -0.997, p=0.001) with high inter-study heterogeneity (I²=93.7%). CONCLUSIONS: Using pre- and post-intervention data, this SRMA indicates a significant reduction in SDF and seminal MDA levels in infertile men with clinical varicocele treated with VR. These findings may have important implications for the future management of this selected group of infertile patients.

Technical Aspects and Clinical Limitations of Sperm DNA Fragmentation Testing in Male Infertility: A Global Survey, Current Guidelines, and Expert Recommendations.

PURPOSE: Sperm DNA fragmentation (SDF) is a functional sperm abnormality that can impact reproductive potential, for which four assays have been described in the recently published sixth edition of the WHO laboratory manual for the examination and processing of human semen. The purpose of this study was to examine the global practices related to the use of SDF assays and investigate the barriers and limitations that clinicians face in incorporating these tests into their practice. MATERIALS AND METHODS: Clinicians managing male infertility were invited to complete an online survey on practices related to SDF diagnostic and treatment approaches. Their responses related to the technical aspects of SDF testing, current professional society guidelines, and the literature were used to generate expert recommendations via the Delphi method. Finally, challenges related to SDF that the clinicians encounter in their daily practice were captured. RESULTS: The survey was completed by 436 reproductive clinicians. Overall, terminal deoxynucleotidyl transferase deoxyuridine triphosphate Nick-End Labeling (TUNEL) is the most commonly used assay chosen by 28.6%, followed by the sperm chromatin structure assay (24.1%), and the sperm chromatin dispersion (19.1%). The choice of the assay was largely influenced by availability (70% of respondents). A threshold of 30% was the most selected cut-off value for elevated SDF by 33.7% of clinicians. Of respondents, 53.6% recommend SDF testing after 3 to 5 days of abstinence. Although 75.3% believe SDF testing can provide an explanation for many unknown causes of infertility, the main limiting factors selected by respondents are a lack of professional society guideline recommendations (62.7%) and an absence of globally accepted references for SDF interpretation (50.3%). CONCLUSIONS: This study represents the largest global survey on the technical aspects of SDF testing as well as the barriers encountered by clinicians. Unified global recommendations regarding clinician implementation and standard laboratory interpretation of SDF testing are crucial.

Risk of unfavorable outcomes after penile prosthesis implantation - results from a national registry (INSIST-ED).

Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien-Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56-67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie's disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65-76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.

Consensus and Diversity in the Management of Varicocele for Male Infertility: Results of a Global Practice Survey and Comparison with Guidelines and Recommendations.

PURPOSE: Varicocele is a common problem among infertile men. Varicocele repair (VR) is frequently performed to improve semen parameters and the chances of pregnancy. However, there is a lack of consensus about the diagnosis, indications for VR and its outcomes. The aim of this study was to explore global practice patterns on the management of varicocele in the context of male infertility. MATERIALS AND METHODS: Sixty practicing urologists/andrologists from 23 countries contributed 382 multiple-choice-questions pertaining to varicocele management. These were condensed into an online questionnaire that was forwarded to clinicians involved in male infertility management through direct invitation. The results were analyzed for disagreement and agreement in practice patterns and, compared with the latest guidelines of international professional societies (American Urological Association [AUA], American Society for Reproductive Medicine [ASRM], and European Association of Urology [EAU]), and with evidence emerging from recent systematic reviews and meta-analyses. Additionally, an expert opinion on each topic was provided based on the consensus of 16 experts in the field. RESULTS: The questionnaire was answered by 574 clinicians from 59 countries. The majority of respondents were urologists/uro-andrologists. A wide diversity of opinion was seen in every aspect of varicocele diagnosis, indications for repair, choice of technique, management of sub-clinical varicocele and the role of VR in azoospermia. A significant proportion of the responses were at odds with the recommendations of AUA, ASRM, and EAU. A large number of clinical situations were identified where no guidelines are available. CONCLUSIONS: This study is the largest global survey performed to date on the clinical management of varicocele for male infertility. It demonstrates: 1) a wide disagreement in the approach to varicocele management, 2) large gaps in the clinical practice guidelines from professional societies, and 3) the need for further studies on several aspects of varicocele management in infertile men.

Which patient may benefit the most from penile prosthesis implantation?

BACKGROUND: Penile prosthesis implantation has been associated with overall good functional outcomes. Of relevance, some patients reported higher level of satisfaction and quality of life. AIM: We investigated the profile of the patients who may benefit the most from penile prosthesis implantation. MATERIALS AND METHODS: Data from a national multi-institutional registry of penile prostheses including patients treated from 2014 to 2017 in Italy (Italian Nationwide Systematic Inventarization of Surgical Treatment for Erectile Dysfunction) were analyzed. All data have been prospectively recorded by 45 surgeons on a dedicated website (www.registro.andrologiaitaliana.it) and revised by a single data manager. Patients' baseline characteristics were recorded. In order to simultaneously evaluate perceived penile prosthesis function and quality of life, all patients were re-assessed at 1-year follow-up using the validated questionnaire Quality of Life and Sexuality with Penile Prosthesis. High quality of life after surgery was defined as a score higher than the 75th percentile in each of the subdomains of the Quality of Life and Sexuality with Penile Prosthesis questionnaire. Logistic regression analysis tested the association between clinical characteristics and high quality of life after penile prosthesis implantation. RESULTS: Follow-up data were available for 285 patients (median age 60 years; interquartile range: 56-67) who underwent penile prosthesis implantation. Erectile dysfunction etiology was organic in 40% (114), pelvic surgery/radiotherapy in 39% (111), and Peyronie's disease in 21% (60) of the cases. Patients showed good overall Quality of Life and Sexuality with Penile Prosthesis scores at 1-year follow-up for functional (22/25), personal (13/15), relational (17/20), and social (13/15) domains. Overall, 27.0% (77) of patients achieved scores consistent with the high quality of life definition. These patients did not differ in terms of median age (60 vs. 62), type of prosthesis (inflatable penile prostheses: 95% in both of the cases), and post-operative complications (10% vs. 14%) than those with lower quality of life score (all p > 0.1). At logistic regression analysis, erectile dysfunction etiology was the only factor independently associated with high quality of life at 1 year after surgery (p = 0.02). Patients treated for Peyronie's disease (odds ratio: 2.62; p = 0.01; 95% confidence interval: 1.20-5.74) were more likely to report better outcomes after accounting for age, post-operative complications, and surgical volume. CONCLUSION: Penile prosthesis implantation is associated with an overall good quality of life. The subset of patients affected by erectile dysfunction secondary to Peyronie's disease seemed to benefit the most from penile prosthesis implantation in terms of functional outcomes, relationship with their partners and the outside world, and perceived self-image. The systematic use of validated questionnaires specifically addressed at evaluating quality of life and satisfaction after penile prosthesis implantation should be further implemented in future studies to better define the predictors of optimal satisfaction after penile prosthesis implantation.

Antisperm Antibody Testing: A Comprehensive Review of Its Role in the Management of Immunological Male Infertility and Results of a Global Survey of Clinical Practices.

Antisperm antibodies (ASA), as a cause of male infertility, have been detected in infertile males as early as 1954. Multiple causes of ASA production have been identified, and they are due to an abnormal exposure of mature germ cells to the immune system. ASA testing (with mixed anti-globulin reaction, and immunobead binding test) was described in the WHO manual 5th edition and is most recently listed among the extended semen tests in the WHO manual 6th edition. The relationship between ASA and infertility is somewhat complex. The presence of sperm agglutination, while insufficient to diagnose immunological infertility, may indicate the presence of ASA. However, ASA can also be present in the absence of any sperm agglutination. The andrological management of ASA depends on the etiology and individual practices of clinicians. In this article, we provide a comprehensive review of the causes of ASA production, its role in immunological male infertility, clinical indications of ASA testing, and the available therapeutic options. We also provide the details of laboratory procedures for assessment of ASA together with important measures for quality control. Additionally, laboratory and clinical scenarios are presented to guide the reader in the management of ASA and immunological male infertility. Furthermore, we report the results of a recent worldwide survey, conducted to gather information about clinical practices in the management of immunological male infertility.

Post-Vasectomy Semen Analysis: Optimizing Laboratory Procedures and Test Interpretation through a Clinical Audit and Global Survey of Practices.

PURPOSE: The success of vasectomy is determined by the outcome of a post-vasectomy semen analysis (PVSA). This article describes a step-by-step procedure to perform PVSA accurately, report data from patients who underwent post vasectomy semen analysis between 2015 and 2021 experience, along with results from an international online survey on clinical practice. MATERIALS AND METHODS: We present a detailed step-by-step protocol for performing and interpretating PVSA testing, along with recommendations for proficiency testing, competency assessment for performing PVSA, and clinical and laboratory scenarios. Moreover, we conducted an analysis of 1,114 PVSA performed at the Cleveland Clinic's Andrology Laboratory and an online survey to understand clinician responses to the PVSA results in various countries. RESULTS: Results from our clinical experience showed that 92.1% of patients passed PVSA, with 7.9% being further tested. A total of 78 experts from 19 countries participated in the survey, and the majority reported to use time from vasectomy rather than the number of ejaculations as criterion to request PVSA. A high percentage of responders reported permitting unprotected intercourse only if PVSA samples show azoospermia while, in the presence of few non-motile sperm, the majority of responders suggested using alternative contraception, followed by another PVSA. In the presence of motile sperm, the majority of participants asked for further PVSA testing. Repeat vasectomy was mainly recommended if motile sperm were observed after multiple PVSA's. A large percentage reported to recommend a second PVSA due to the possibility of legal actions. CONCLUSIONS: Our results highlighted varying clinical practices around the globe, with controversy over the significance of non-motile sperm in the PVSA sample. Our data suggest that less stringent AUA guidelines would help improve test compliance. A large longitudinal multi-center study would clarify various doubts related to timing and interpretation of PVSA and would also help us to understand, and perhaps predict, recanalization and the potential for future failure of a vasectomy.

Circumferential Acquired Macropenis: Definition, Literature Review and Proposal of Geometrically-Based Reduction Corporoplasty.

INTRODUCTION: Over the years, scattered cases of acquired penile girth increase have been published with different terms, the common clinical feature being a mechanically hampered penetration. AIM: To search for all published cases of acquired penile girth increase, and to propose a geometrically-based reduction corporoplasty. METHODS: A case of acquired penile bilateral albuginea herniation prompted us to a PubMed, EMBASE and Google Scholar literature review from 1970 to 2021, in search for similar conditions. MAIN OUTCOME MEASURE: We identified 7 cases of acquired penile girth increase; the geometric approach used to surgically correct bilateral corporal herniation proved successful in our case. RESULTS: In 5 of the 7 cases of acquired penile girth increase, priapistic episodes were deemed the causal factor; in the remaining 2 and in ours, a clear etiology could not be identified. CONCLUSION: "Circumferential acquired macropenis" describes the unusual syndrome of acquired penile girth increase, that encompasses 2 distinct etiologies: post-priapistic cases, characterized by penile girth increase both in flaccidity and erection, and idiopathic cases, characterized by girth increase in erection only, and at surgery by a thinned albuginea in the affected area. Pescatori ES, Drei B, Rabito S Circumferential Acquired Macropenis: Definition, Literature Review and Proposal of Geometrically-Based Reduction Corporoplasty. Sex Med 2022;10:100460.

Outcomes and predictive factors of successful salvage microdissection testicular sperm extraction (mTESE) after failed classic TESE: results from a multicenter cross-sectional study.

Microdissection testicular sperm extraction (mTESE) has been proposed as a salvage treatment option for men with a previously failed classic TESE (cTESE), but data are scarce. We aimed to assess the outcome of and potential predictors of successful salvage mTESE in a cohort of men previously submitted to unfruitful cTESE. Data from 61 men who underwent mTESE after a failed cTESE between 01/2014 and 10/2020, at 6 tertiary-referral centres in Italy were analysed. All men were investigated with semen analyses, testicular ultrasound, hormonal and genetic blood testing. Pathological diagnosis from TESE was collected in every man. Descriptive statistics and logistic regression models were used to investigate potential predictors of positive sperm retrieval (SR+) after salvage mTESE. Baseline serum Follicle-Stimulating hormone (FSH) and total testosterone levels were 17.2 (8.6-30.1) mUI/mL and 4.7 (3.5-6.4) ng/mL, respectively. Sertoli-cell-only syndrome (SCOS), maturation arrest (MA) and hypospermatogenesis were found in 24 (39.3%), 21 (34.4%) and 16 (26.2%) men after cTESE, respectively. At mTESE, SR+ was found in 30 (49.2%) men. Patients with a diagnosis of hypospermatogenesis had a higher rate of SR+ (12/16 (75%)) compared to MA (12/21 (57.1%)) and SCOS (6/24 (25%)) patients at mTESE (p < 0.01). No clinical and laboratory differences were observed between SR+ and SR- patients at mTESE. There were no significant complications after mTESE. At multivariable logistic regression analysis, only hypospermatogenesis (OR 9.5; p < 0.01) was independently associated with SR+ at mTESE, after accounting for age and FSH.In conclusion, salvage mTESE in NOA men with previous negative cTESE was safe and promoted SR+ in almost 50%. A baseline pathology of hypospermatogenesis at cTESE emerged as the only independent predictor of positive outcomes at salvage mTESE.

Sperm Vitality and Necrozoospermia: Diagnosis, Management, and Results of a Global Survey of Clinical Practice.

Sperm vitality testing is a basic semen examination that has been described in the World Health Organization (WHO) Laboratory Manual for the Examination and Processing of Human Semen from its primary edition, 40 years ago. Several methods can be used to test sperm vitality, such as the eosin-nigrosin (E-N) stain or the hypoosmotic swelling (HOS) test. In the 6th (2021) edition of the WHO Laboratory Manual, sperm vitality assessment is mainly recommended if the total motility is less than 40%. Hence, a motile spermatozoon is considered alive, however, in certain conditions an immotile spermatozoon can also be alive. Therefore, the differentiation between asthenozoospermia (pathological decrease in sperm motility) and necrozoospermia (pathological decrease in sperm vitality) is important in directing further investigation and management of infertile patients. The causes leading to necrozoospermia are diverse and can either be local or general, testicular or extra-testicular. The andrological management of necrozoospermia depends on its etiology. However, there is no standardized treatment available presently and practice varies among clinicians. In this study, we report the results of a global survey to understand current practices regarding the physician order of sperm vitality tests as well as the management practices for necrozoospermia. Laboratory and clinical scenarios are presented to guide the reader in the management of necrozoospermia with the overall objective of establishing a benchmark ranging from the diagnosis of necrozoospermia by sperm vitality testing to its clinical management.

Comparing the Italian and North American prospective registries on penile prosthesis surgery: are there relevant differences in treatment indications and patients' management?

Previous studies have shown discrepancies among countries in terms of treatment indications and patients' management due to different health care policies. Penile prosthesis implantation (PPI) is a highly effective treatment for erectile dysfunction (ED), which may have different accessibility according to the type of health system. We compared clinical characteristics of patients included in two national registries on PPI to investigate the influence of different health care systems on treatment indication and accessibility. The multicenter Italian Nationwide Systematic Inventarization of Surgical Treatment for ED (INSIST-ED) Registry and the multicenter Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration (PROPPER), respectively for Italy and North America were considered. Clinical characteristics of patients included in both registries were compared using Wilcoxon Rank Sum test and the Pearson's Chi square test. Patients submitted to PPI in Italy are significantly younger (age: 61.2 vs. 63.8 years; p ≤ 0.001) compared with North America. The majority of patients are treated for post-radical prostatectomy ED in both registries (Italy: 31%; North America: 27%), although diabetes and cardiovascular diseases are more frequent reasons for PPI in the PROPPER registry (p ≤ 0.001), reflecting differences in disease prevalence among countries. In North America a non-hydraulic implant is considered only in 1% of cases as compared with 3% in Italy (p ≤ 0.001). In terms of postoperative management, a compressive surgical dressing (98% vs. 24%; p ≤ 0.001) is a more common strategy in North America. Finally, in Italy most surgeries are performed in a public hospital (82%), while the private setting (70.8%) is more common in North America (p ≤ 0.001). These findings suggest differences in health care systems between Italy and North America. A system like the American one would guarantee easier access to PPI in countries where the National Health System is mainly based on reimbursement to public hospital settings and where patients choosing private settings have to pay by themselves.

How much do people know about male sexual problems? A survey in a selected population sample.

OBJECTIVES: Our purpose has been to investigate by an ad hoc questionnaire the knowledge of several aspects of male sexual dysfunction in a significant sample of men and women (largely not physicians) attending an International Health Care Exhibition, held in Italy. MATERIALS AND METHODS: The survey took place during Exposanità, 2018 edition, aimed at medical and non-medical professionals. We devised as investigation tool an ad hoc anonymous questionnaire in two versions, one for each sex. Object of this report are questions addressing subject's knowledge of prevalence of erectile dysfunction (ED), ED causes, ED as early sign of coronary heart disease/myocardial infarction, available ED treatments and attitudes towards penile prosthesis, and reimbursement of ED treatments. RESULTS: As many as 1094 Convention attendees (495 men, 599 women) participated to the survey (about 4% of total attendees). Mean sample age was 40.5 years in men and 39.9 years in women. Forty-three percent of the sample worked in healthrelated professions, 5.9% being physicians. Respondents globally over-estimated the prevalence of ED. Both responding men and women rated psychologic and lifestyle factors as the most frequent ED causes. The majority of responders did not regard ED as a possible predictor of cardiovascular events. Oral pills resulted the most known ED treatment by both men (77.2%) and women (79.1%). Psychotherapy ranked as the second most known treatment approach. Other effective ED treatments (intracavernosal injections, vacuum erection device, penile prostheses) were known by a minority of men (22.2-27.9%) and women (19.2-20.2%). Roughly half of the sample (50.7% of men and 48.4% of women) were willing to choose (men) or to support (women) the penile prosthesis option in cases of severe ED; majority of both sexes (71.3% of men and 76.3% of women) expressed no resistances to the perspective of penile prosthesis use. Vast majority of men (80.3%) and women (80.4%) considered that coverage for ED treatments should be provided by the National Health System. CONCLUSIONS: The outcomes of our survey show both an elevated prevalence of misconceptions on the role of organic factors in the etiology of ED, and ignorance of the implications of ED on cardiovascular health. Knowledge of available second level ED treatments resulted scanty. Nonetheless, when confronted with the most aggressive treatment, penile prosthesis, majority of both genders responders would undergo/support this surgery, should it be the only way to solve the erectile problem. In this perspective, population appears ready and overall keen to a treatment option that too often is not addressed by majority of the medical community when counseling men with severe ED not responsive to conservative approach.

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.

Quality of Life and Sexual Function Benefits of Long-Term Testosterone Treatment: Longitudinal Results From the Registry of Hypogonadism in Men (RHYME).

BACKGROUND: The benefits and risks of long-term testosterone administration have been a topic of much scientific and regulatory interest in recent years. AIM: To assess long-term quality of life (QOL) and sexual function benefits of testosterone replacement therapy (TRT) prospectively in a diverse, multinational cohort of men with hypogonadism. METHODS: A multinational patient registry was used to assess long-term changes associated with TRT in middle-age and older men with hypogonadism. Comprehensive evaluations were conducted at 6, 12, 24, and 36 months after enrollment into the registry. OUTCOMES: QOL and sexual function were evaluated by validated measures, including the Aging Males' Symptom (AMS) Scale and the International Index of Erectile Function (IIEF). RESULTS: A total of 999 previously untreated men with hypogonadism were enrolled at 25 European centers, 750 of whom received TRT at at least one visit during the period of observation. Patients on TRT reported rapid and sustained improvements in QOL, with fewer sexual, psychological, and somatic symptoms. Modest improvements in QOL and sexual function, including erectile function, also were noted in RHYME patients not on TRT, although treated patients showed consistently greater benefit over time in all symptom domains compared with untreated patients. AMS total scores for patients on TRT were 32.8 (95% confidence interval = 31.3-34.4) compared with 36.6 (95% confidence interval = 34.8-38.5) for untreated patients (P < .001). Small but significant improvements in IIEF scores over time also were noted with TRT. Approximately 25% of treated and untreated men also used phosphodiesterase type 5 inhibitors, with notable differences in the frequency of phosphodiesterase type 5 inhibitor prescription use according to physician specialty and geographic site location. CLINICAL IMPLICATIONS: TRT-related benefits in QOL and sexual function are well maintained for up to 36 months after initiation of treatment. STRENGTHS AND LIMITATIONS: The major strengths are the large, diverse patient population being treated in multidisciplinary clinical settings. The major limitation is the frequency of switching from one formulation to another. CONCLUSION: Overall, we confirmed the broad and sustained benefits of TRT across major QOL dimensions, including sexual, somatic, and psychological health, which were sustained over 36 months in our treatment cohort. Rosen RC, Wu F, Behre H, et al. Quality of Life and Sexual Function Benefits Effects of Long-Term Testosterone Treatment: Longitudinal Results From the Registry of Hypogonadism in Men (RHYME). J Sex Med 2017;14:1104-1115.

INSIST-ED: Italian Society of Andrology registry on penile prosthesis surgery. First data analysis.

OBJECTIVES: The Italian Society of Andrology, i.e. "Società Italiana di Andrologia" (S.I.A.), launched on December 2014 a prospective, multicenter, monitored and internal review board approved Registry for penile implants, the "INSIST-ED" (Italian Nationwide Systematic Inventarisation of Surgical Treatment for ED) Registry. Purpose of this first report is to present a baseline data analysis of the characteristics of penile implant surgery in Italy. MATERIAL AND METHODS: The INSIST-ED Registry is open to all surgeons implanting penile prostheses (all brands, all models) in Italy, providing anonymous patient, device, surgical procedure, outcome, follow-up data, for both first and revision surgeries. A Registry project Board overviews all the steps of the project, and a Registry Monitor interacts with the Registry implanting surgeons. RESULTS: As by April 8, 2016, 31 implanting surgeons actively joined the Registry, entering 367 surgical procedures in its database, that comprise: 310 first implants, 43 prosthesis substitutions, 14 device explants without substitution. Implanted devices account for: 288 three-component devices (81,3%), 20 two-component devices (5,4%), 45 non-hydraulic devices (12,3%). Leading primary ED etiologies in first implant surgeries resulted: former radical pelvic surgery in 111 cases (35,8%), Peyronie's disease in 66 cases (21,3%), diabetes in 39 cases (12,6%). Two intraoperative complications have been recorded. Main reasons for 57 revision surgeries were: device failure (52,6%), erosion (19,3%), infection (12,3%), patient dissatisfaction (10,5%). Surgical settings for patients undergoing a first penile implant were: public hospitals in 251 cases (81%), private environments in 59 cases (19%). CONCLUSIONS: The INSIST-ED Registry represents the first European experience of penile prosthesis Registry. This baseline data analysis shows that: three-pieces inflatable prosthesis is the most implanted device, leading etiology of erectile dysfunction (ED) in patient receiving a prosthesis is former radical pelvic surgery, primary reason for revision surgery is device failure, primary settings for first penile implant surgery are public hospitals. Evaluation of penile implant impact on recipients quality of life is presently ongoing.

Subsequent impaired fertility (with or without sperm worsening) in men who had fathered children after a left varicocelectomy: A novel population?

OBJECTIVES: The objective of this paper was to assess whether the beneficial effects of a varicocelectomy on fertility are transitory or definitive after a first fathering. MATERIALS AND METHODS: This was a retrospective study which involved seven andrological centers. The files of 2223 patients who underwent subinguinal ligation of a high grade left varicocele for (oligo)±(astheno)±(terato)-spermia and infertility between January 1(st), 2002 and January 1(st) 2013 were reviewed. Inclusion criteria for the patients were the following: Sperm count improvement and fathering a child after an uneventful left varicocelectomy; 745 patients were considered. Patients who had undergone three assessments for (in-) fertility: Before surgery, before the first fathering and after the first fathering were included in the study. Each assessment included: Clinical history, physical examination, two sperm analyses, bilateral scrotal Duplex scans, blood hormonal levels [follicle stimulating hormone (FSH), luteinising hormone (LH), testosterone (T) and prolactin (PRL)]. RESULTS: Forty patients were finally studied; they all had an improved sperm count and had fathered once after surgery. Fifteen had fathered twice and still had their sperm count increased after the second fathering. Twenty-five patients could not father twice; 13 patients had their sperm count decreased after the first fathering and 12 did not. A decrease in testicular volume and an increase in FSH paralleled the worsening of sperm concentration, motility and morphology after fathering. No other differences could be observed between the groups. CONCLUSIONS: Our data indicated that the beneficial effects of a varicocelectomy might be transitory in some cases.

DNA integrity is maintained after freeze-drying of human spermatozoa.

OBJECTIVE: To evaluate the effects on human spermatozoa of freeze-drying, also known as lyophilization, and of cryopreservation in liquid nitrogen. DESIGN: Prospective experimental study. SETTING: Reproductive medicine unit and a private IVF center. PATIENT(S): Thirty healthy male donors. INTERVENTION(S): Sperm samples from 30 donors divided as two aliquots, one to be lyophilized and the other to be cryopreserved in liquid nitrogen. MAIN OUTCOME MEASURE(S): Assessment of count, motility, morphology, viability, DNA integrity, chromosomal status, and birefringence properties of lyophilized and cryopreserved human spermatozoa compared with the same parameters in the fresh sample. RESULT(S): Although sperm viability and motility were totally compromised after freeze-drying, the sperm chromatin structure was not altered in comparison with fresh samples, which demonstrated that the procedure did not affect DNA integrity. The sperm-head inner protoplasmic structures were also preserved, which was estimated by assessing the corresponding birefringence characteristics. After cryopreservation with liquid nitrogen, the motility, viability, and DNA integrity of spermatozoa were statistically significantly reduced compared with the fresh samples; the proportion of sperm cells with abnormal head birefringence increased meaningfully. CONCLUSION(S): The process of freeze-drying deeply damages cell membranes; however, unlike with liquid nitrogen preservation, it does not affect DNA integrity.