ProsTAV, a clinically useful test in prostate cancer: an extension study.

PURPOSE: To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa). METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center's routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined. RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI. CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.

ProsTAV, a novel blood-based test for biopsy decision management in significant prostate cancer.

BACKGROUND: Current pathways in early diagnosis of prostate cancer (PCa) can lead to unnecessary biopsy procedures. Here, we used telomere analysis to develop and evaluate ProsTAV®, a risk model for significant PCa (Gleason score >6), with the objective of improving the PCa diagnosis pathway. METHODS: This retrospective, multicentric study analyzed telomeres from patients with serum PSA 3-10 ng/mL. High-throughput quantitative fluorescence in-situ hybridization was used to evaluate telomere-associated variables (TAVs) in peripheral blood mononucleated cells. ProsTAV® was developed by multivariate logistics regression based on three clinical variables and six TAVs. The predictive capacity and accuracy of ProsTAV® were summarized by receiver operating characteristic (ROC) curves and its clinical benefit with decision curves analysis. RESULTS: Telomeres from 1043 patients were analyzed. The median age of the patients was 63 years, with a median PSA of 5.2 ng/mL and a percentage of significant PCa of 23.9%. A total of 874 patients were selected for model training and 169 patients for model validation. The area under the ROC curve of ProsTAV® was 0.71 (95% confidence interval [CI], 0.62-0.79), with a sensitivity of 0.90 (95% CI, 0.88-1.0) and specificity of 0.33 (95% CI, 0.24-0.40). The positive predictive value was 0.29 (95% CI, 0.21-0.37) and the negative predictive value was 0.91 (95% CI, 0.83-0.99). ProsTAV® would make it possible to avoid 33% of biopsies. CONCLUSIONS: ProsTAV®, a predictive model based on telomere analysis through TAV, could be used to increase the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/mL.

Male Infertility and the Risk of Developing Testicular Cancer: A Critical Contemporary Literature Review.

Background and Objectives: The relationship between male infertility (MI) and testicular cancer (TC) is bilateral. On one hand, it is well-established that patients diagnosed with TC have a high risk of pre- and post-treatment infertility. On the other hand, the risk of developing TC in male infertile patients is not clearly defined. The objective of this review is to analyze the histopathological, etiological, and epidemiological associations between MI and the risk of developing testicular cancer. This review aims to provide further insights and offer a guide for assessing the risk factors for TC in infertile men. Materials and Methods: A comprehensive literature search was conducted to identify relevant studies discussing the relationship between MI and the risk of developing TC. Results: The incidence rates of germ cell neoplasia in situ (GCNIS) appear to be high in infertile men, particularly in those with low sperm counts. Most epidemiological studies have found a statistically significant risk of developing TC among infertile men compared to the general or fertile male populations. The concept of Testicular Dysgenesis Syndrome provides an explanatory model for the common etiology of MI, TC, cryptorchidism, and hypospadias. Clinical findings such as a history of cryptorchidism could increase the risk of developing TC in infertile men. Scrotal ultrasound evaluation for testis lesions and microlithiasis is important in infertile men. Sperm analysis parameters can be useful in assessing the risk of TC among infertile men. In the future, sperm and serum microRNAs (miRNAs) may be utilized for the non-invasive early diagnosis of TC and GCNIS in infertile men. Conclusions: MI is indeed a risk factor for developing testicular cancer, as demonstrated by various studies. All infertile men should undergo a risk assessment using clinical examination, ultrasound, and semen parameters to evaluate their risk of TC.

Penile Implant Surgery Satisfaction Assessment.

BACKGROUND: Several studies reported high satisfaction rates (> 90%) for patients and their partners after penile prosthesis (PP) implantation. AIM: To describe and critically discuss the current evidence regarding the assessment of patient and partner satisfaction after penile implant surgery. METHODS: A critical narrative review of the studies investigating the patient and partner satisfaction after PP implantation was designed. Papers in English-language published until January 2021 were included. OUTCOMES: The main outcome investigated was patient and partner satisfaction after penile implant surgery. RESULTS: The International Index of Erectile Function , the Erectile Dysfunction Inventory of Treatment Satisfaction , the Treatment Satisfaction Scale , and the Quality of Life and Sexuality with Penile Prosthesis are the best-known validated tools used to assess satisfaction after PP implantation. Except for Quality of Life and Sexuality with Penile Prosthesis , they were not validated in patients undergoing penile implant surgery. The lack of an "ad hoc" tool has led to the widespread of nonvalidated questionnaires. Several tools can be useful in the preimplantation counseling, such as the mnemonic Compulsive/obsessive, Unrealistic, Revision, Surgeon Shopping, Entitled, Denial, and Psychiatric , the Minnesota Multiphasic Personality Inventory, the Brief Sexual Symptom Checklist for Men , the Attitude towards Penile Implant , and the Attitude Attributed to the Partner towards Penile Implant . CLINICAL IMPLICATIONS: Improvement of knowledge regarding the available tools to evaluate the satisfaction after penile implant surgery. STRENGTHS & LIMITATIONS: Comprehensive and thorough review of all the main validated questionnaires available to assess satisfaction in patients with PP. Lack of a systematic approach and quantitative data analysis. CONCLUSION: Despite the high satisfaction rate reported in the literature, most of the studies used suboptimal or non-validated questionnaires to assess patients undergoing penile implant surgery. Future research is needed to develop and validate a specific, complete and easy-to-use questionnaire. Manfredi C, Fortier É, Faix A, et al. Penile Implant Surgery Satisfaction Assessment. J Sex Med 2021;18:868-874.

A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease.

BACKGROUND: Some studies showed encouraging results on the efficacy and safety of penile traction therapy after Peyronie's disease (PD) surgery. The early traction therapy (ETT) could be an effective and safe approach to minimize penile shortening in patients undergoing PD surgery. AIM: To evaluate the feasibility, efficacy, and safety of a novel penile splint as ETT in patients with PD undergoing grafting techniques. METHODS: Patients with PD underwent plaque incision and grafting technique; at the end of the procedure, a novel penile splint (ETT) was applied to all patient. The device consisted of 2 10CH intubating stylets, self-adapted to each patient, that kept the penis stretched with the aid of non-absorbable sutures. The total expense for the materials needed to build each penile splint was less than 15 euros. This active traction was maintained for 1-3 weeks; then, we removed the stitches leaving the device on-site for a passive traction. Within 3-4 weeks from surgery, the penile splint was replaced by a standard penile traction device. OUTCOMES: The main outcomes evaluated at 6 months included stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse. RESULTS: A total of 46 patients were enrolled. The median preoperative IIEF-EF, penile curvature, and SPL were 27 points, 70°, and 13 cm, respectively. The median follow-up was 15 months. The median postoperative IIEF-EF was 25 points (P < .001). The median residual penile curvature was 10° (P < .001). The median postoperative SPL was 13 cm (P = .269). 8 patients (17.4%) lost 1 cm of SPL; no shortening greater than 1 cm was recorded. The median time to first satisfactory sexual intercourse and patient satisfaction score was 6 weeks and 9 points, respectively. CLINICAL IMPLICATIONS: Our results could pave the way for a new line of research, which in turn could lead to an improvement in the postoperative management of the patient undergoing surgery for PD. STRENGTH & LIMITATIONS: This is the first study evaluating the ETT after PD surgery. The main limitation of this study is the lack of a randomized control group. Other weaknesses are the small sample size and the short follow-up time. CONCLUSION: Our novel penile splint is inexpensive, easy to assemble, and adaptable to the patient. ETT using this novel device, followed by standard traction therapy, seems to be feasible, effective, and safe. Fernández-Pascual E, Manfredi C, Cocci A, et al. A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease. J Sex Med 2020;17:1819-1824.

Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease.

BACKGROUND: A xenograft consisting of equine collagen coated with human fibrinogen and thrombin (TachoSil; Baxter, CA) has recently been introduced in grafting procedures for Peyronie's disease (PD). AIM: To describe the results of a multicenter prospective registry on patients with PD undergoing plaque incision or and grafting (PIG) or plaque excision and grafting (PEG) with collagen fleece TachoSil, to evaluate the efficacy and safety of this procedure. METHODS: A prospective non-controlled multicenter study of patients with PD was performed between May 2016 and March 2018. Patients from 10 centers with stable PD for at least 3 months, difficulties in sexual intercourse, normal erectile function with or without pharmacological treatment, curvature >45°, and/or penile shortening and/or complex deformities were included. All patients underwent PIG/PEG with collagen fleece TachoSil. OUTCOMES: The main outcome measure of this study were penile curvature correction (intraoperative), penile shortening (intraoperative), erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) and the Erection Hardness Score, subjective patient outcomes with non-validated questionnaires, and complications. RESULTS: A total of 52 patients were enrolled in the study. The mean (SD) preoperative penile curvature was 72.8° (17.0). PIG was the preferred technique (80.8%). Intraoperatively, complete curvature correction was achieved in 92.3%, and no significant penile shortening was recorded in 80.8% of subjects. Subjective penile shortening was reported in 83.3% of patients at 6 months. No objective measurement of penile curvature and length was recorded during follow-up. No statistically significant difference from the baseline was found in IIEF-5 and Erection Hardness Score at 3 or at 6 months, although 16.7% of men experienced a worsening of IIEF-5 scores and 14.3% required de novo phosphodiesterase type 5 inhibitor use. 6 months after surgery, 78.5% of men were satisfied with intervention. Swelling and ecchymosis/hematoma were the most common perioperative complications (40.4%). 2 cases (3.8%) of wound infection were recorded. At 6 months, 35.7% of patients reported mild penile hypesthesia. CLINICAL IMPLICATIONS: Our results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening. STRENGTH & LIMITATIONS: This is the first multicentre study on patients with PD undergoing grafting with TachoSil without concomitant placement of penile prosthesis. The main limitations are the short follow-up and the relatively small sample size. CONCLUSION: Grafting with TachoSil after PIG/PEG in patients with PD is an effective and safe procedure. Among the main advantages of this technique, there are ease of use of the graft and reduced operative time. Fernández-Pascual E, Manfredi C, Torremadé J, et al. Multicenter Prospective Study of Grafting With Collagen Fleece TachoSil in Patients With Peyronie's Disease. J Sex Med 2020;17:2279-2286.

Clinical Recommendations From the European Society for Sexual Medicine Exploring Partner Expectations, Satisfaction in Male and Phalloplasty Cohorts, the Impact of Penile Length, Girth and Implant Type, Reservoir Placement, and the Influence of Comorbidities and Social Circumstances.

INTRODUCTION: To date, several aspects of inflatable penile prosthesis (IPP) surgical procedure have been poorly studied. AIM: The aim of this study was to review the evidence associated with IPP implantation and provide clinical recommendations on behalf of the European Society for Sexual Medicine (ESSM). Overall, 130 peer-reviewed studies and systematic reviews, which were published from 2007-2018 in the English language, were included. METHODS: MEDLINE and EMBASE were searched for randomized clinical trials, meta-analyses, and open-label prospective and retrospective studies. MAIN OUTCOME MEASURE: The panel provided statements exploring patients and partner expectations, satisfaction in male and phalloplasty cohorts, the impact of penile length, girth and implant type, reservoir placement, the influence of comorbidities, and social circumstances. Levels of evidence were provided according to the Oxford 2011 criteria and graded as for the Oxford Centre for Evidence-Based Medicine recommendations. RESULTS: In the preoperative setting, it is fundamental to identify and interact with difficult patients with the intention of enhancing the surgeon's ability to establish the surgeon-patient relationship, reduce physical and legal risk, as well as enhancing patient satisfaction. To address this need, the mnemonic Compulsive, Unrealistic, Revision, Surgeon Shopping, Entitled, Denial, and Psychiatric ("CURSED") has been suggested to identify patients who are at high risk of dissatisfaction. The current recommendations suggest improving glycemic control in patients with diabetes. Available evidence suggests evaluating transplant recipients with the criteria of Barry, consisting of stable graft function for >6 months, avoidance of intra-abdominal reservoir placement, and low-dose immunosuppression. HIV status does not represent a contraindication for surgery. Smoking, peripheral vascular disease, and hypertension may be associated with an increased risk of revision surgery. Patients with spinal cord injury may receive IPP. Patients aged ≥70 years, as well as obese patients, can be offered IPP. The IPP implantation can be performed in patients with stable Peyronie's disease. Ectopic high submuscular reservoir placement can be considered as an alternative method. CLINICAL IMPLICATIONS: There is a relevant lack of high-level data and definite conclusions in certain areas remain difficult to draw. STRENGTH & LIMITATIONS: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. Because of lack of sufficient prospective data, some of the included studies are retrospective and this could be stated as a limitation. CONCLUSION: This ESSM position statement provides recommendations on optimization of patient outcome by patient selection, and individualized peri- and intra-operative management. ESSM encourages centers to collaborate and to create prospective, multicenter registries in order to address this topic of increasing importance. Osmonov D, Christopher AN, Blecher GA, et al. Clinical Recommendations from the European Society for Sexual Medicine Exploring Partner Expectations, Satisfaction in Male and Phalloplasty Cohorts, the Impact of Penile Length, Girth and Implant Type, Reservoir Placement, and the Influence of Comorbidities and Social Circumstances. J Sex Med 2020;17:210-237.

Cadaveric Penile Prosthesis Workshop training improves surgical confidence levels of urologists: South Asian Society for Sexual Medicine course survey.

OBJECTIVES: To analyze the impact of South Asia's first cadaveric hands-on workshop on urologists' training in inflatable penile prosthesis surgery. METHODS: A total of 72 urologists/andrologists participated in the 2019 South Asian Society for Sexual Medicine Pre-congress Penile Prosthesis hands-on workshop. The workshop included 4 h of lectures and 2 h of hands-on cadaveric laboratory experience using three-piece inflatable penile prosthesis. The Shapiro-Wilk test was used on self-rated procedural confidence levels, which proved the normality. A non-parametric McNemar test was used to examine the change in the number of correct answers. RESULTS: Of those who attended the cadaver laboratory, just 45 who answered the survey both before and after the workshop were included for analysis. Significant objective improvements were noted in procedural knowledge test scores (44.30 ± 0.027 vs 72.44 ± 0.024, P < 0.05) and median surgical confidence levels (4 vs 3 and 2, P < 0.001) of the urologists after the completion of the workshop. CONCLUSIONS: Cadaveric hands-on workshop training improves urologists' procedural knowledge and surgical confidence levels in carrying out three-piece inflatable penile prosthesis surgery. The feasibility of such workshops should be considered in increasing the surgical expertise of general urologists in prosthetic urology.

Impact of 68Ga-PSMA PET/CT in the treatment of prostate cancer: Initial experience in Spain.

AIM: To evaluate whether positron-emission tomography/computed tomography with 68Ga-PSMA (68Ga-PSMA PET/CT) influences the therapeutic management of patients with primary or recurrent prostate cancer (PCa). BACKGROUND: Although 68Ga-PSMA PET/CT is one of the best options for staging or restaging patients with PCa, its availability is still very limited in Spain. The present study reports the results of the first group of patients in Spain who underwent 68Ga-PSMA PET/CT imaging. MATERIALS AND METHODS: All patients (n = 27) with a histological diagnosis of PCa who underwent 68Ga-PSMA PET/CT prior to the definitive treatment decision at the only centre with this technology in Spain during 2017-2018 were included. Two nuclear medicine physicians and a radiologist reviewed the imaging studies. The clinical impact was assessed from a theoretical perspective, based on the treatment that would have been applied if no data from the 68Ga-PSMA PET/CT were available. RESULTS: Most patients (n = 26; 96%) had persistent disease or biochemical recurrence after radical prostatectomy, radiotherapy, or combined treatment. One patient underwent 68Ga-PSMA PET/CT imaging to stage high-risk PCa. Overall, 68Ga-PSMA PET/CT was positive in 19 patients (70.4%). In 68.75% of these patients, none of the other imaging tests-MRI, CT, or bone scans-performed prior to the 68Ga-PSMA PET/CT were able to detect the presence of cancerous lesions. Overall, the findings of the 68Ga-PSMA PET/CT led to a modification of the therapeutic approach in 62.96% of the patients in the study. CONCLUSIONS: 68Ga-PSMA PET/CT alters the therapeutic approach in a substantial proportion of patients with PCa.

Penile traction therapy with the new device 'Penimaster PRO' is effective and safe in the stable phase of Peyronie's disease: a controlled multicentre study.

OBJECTIVES: To evaluate the efficacy and safety of a new penile traction device (PTD), 'Penimaster PRO', in a group of patients with stable Peyronie's disease (PD) compared with a non-intervention group in a multicentre study. MATERIAL AND METHODS: A total of 93 patients with chronic stable PD (without erectile dysfunction, with no significant pain, and with a unidirectional curvature of at least 45° being stable for > 3 months) were recruited and followed for a 12-week period. Of these patients, 47 were randomly assigned to the Penimaster PRO group (PG) and 46 to the non-intervention group (NIG). Patients were asked to apply the PTD 3-8 h a day for 12 consecutive weeks, with specific instructions regarding the progressive increase of traction force applied to the penis over time. The primary outcome of the study was the change in the degree of curvature measured in the fully erect state after intracavernosal injection of alprostadil at baseline, 1, 2 and 3 months. Other variables, such as the type of curvature, stretched penile length (SPL), Peyronie's Disease Questionnaire (PDQ) scores, erectile function domain of the International Index of Erectile function (IIEF-EF) score and adverse events (AEs) were also assessed in each visit. RESULTS: Forty-one patients in the PG and 39 in the NIG completed the study. There was an overall reduction in curvature of 31.2° (P < 0.001) at 12 weeks compared to baseline in the PG, representing a 41.1% improvement from baseline, which significantly correlated with the number of daily hours the device was applied in a dose-dependent manner. Those patients using the device < 4 h/day experienced a reduction of 15°-25° (mean 19.7°, 28.8% improvement; P < 0.05), while patients using the device > 6 h/day experienced greater curvature reduction, ranging from 20° to 50° (mean of 38.4°, 51.4% improvement; P < 0.001). In contrast, no significant changes in curvature were observed in the NIG. Furthermore, SPL increased significantly in the PG compared to baseline and compared with the NIG, ranging from 0.5 to 3.0 cm (mean 1.8 cm; P < 0.05). The IIEF-EF score also improved in patients in the PG (by a mean of 5 points). Mild AEs occurred in 43% of patients, such as local discomfort and glans numbness. CONCLUSION: The use of the Penimaster PRO PTD, a non-invasive treatment, should be offered to patients with stable PD for 3 consecutive months before performing any corrective surgery, as this provided a significant reduction in the curvature, an increase in penile length and a significant improvement of the symptoms and bother induced by PD.

Optimizing collagenase Clostridium histolyticum therapy for Peyronie's disease using a novel approach with percutaneous needle tunnelling.

OBJECTIVES: To compare the efficacy and safety of a combined treatment of percutaneous needle tunnelling (PNT) and a modified collagenase Clostridium histolyticum (CCH) protocol (PNT/CCH) vs the modified protocol alone (CCH) in the treatment of Peyronie's disease (PD). PATIENTS AND METHODS: A prospective registry of patients treated with a modified CCH protocol was maintained between June 2014 and February 2018. The last 50 patients received PNT as an adjuvant therapy (PNT/CCH), and their data were compared with those of the other 94 patients treated previously (CCH). PNT involves the creation of multiple holes made percutaneously in the plaque before each injection. The modified protocol consisted of two collagenase injections, at 1-week intervals, followed by penile modelling. Patients used penile traction therapy, tadalafil and pentoxifylline for the next 2 months and were followed up for 6 months. The main outcome was improvement of curvature. Secondary outcomes were improvements in erectile function, PD symptoms, stretched penile length and satisfaction. RESULTS: Improvement in curvature was greater in patients in the PNT/CCH group than in the CCH group (mean ± sd 19.2 ± 6.1° vs 12.7 ± 5.0°; P < 0.001 [36.2 ± 12.5% vs 28.1 ± 14.5%; P = 0.001]). Compared with baseline, both interventions were associated with significant improvement in secondary outcomes. The main complications were ecchymosis, bruising and penile pain, with no significant differences between groups. CONCLUSIONS: Treatment of PD with CCH using our modified protocol in combination with PNT is safe and more effective than the modified protocol alone, with the potential for improved cost-effectiveness.

Surgical Technique for Complex Cases of Peyronie's Disease With Implantation of Penile Prosthesis, Multiple Corporeal Incisions, and Grafting With Collagen Fleece.

INTRODUCTION: Patients with Peyronie's disease (PD) and erectile dysfunction (ED) concomitant with shortening or other malformations benefit from prosthesis implantation and penile lengthening procedures. AIM: To evaluate the safety and efficacy of a multi-incisional technique with penile prosthesis implantation with multiple corporeal incisions and collagen grafting for the surgical management of complex cases of PD with ED and severe penile shortening. METHODS: From February 2015-May 2018, 43 consecutive patients with complex PD were treated using this technique. Implantation of a penile prosthesis (malleable or inflatable [IPP]) together with multiple relaxing tunica albuginea incisions and grafting with a self-adhesive collagen-fibrin fleece (TachoSil, Baxter Healthcare) was performed in all patients by a single surgeon (J.I.M.S.). MAIN OUTCOME MEASURE: Penile length and curvature correction, operative time, and incidence of postoperative complications were recorded as outcome measures. Functional outcomes were measured with questionnaires (International Index of Erectile Function-5, Erection Hardness Score, modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, PD Questionnaire) before and 3 and 6 months after surgery. RESULTS: With a median follow-up of 21 months (range 10-31), mean postsurgical penile lengthening was 2.5 (range 1-5) cm, with an improvement in the Bother domain of the PD Questionnaire of 4.4 (range 2-5) points. The average operative time was 86.7 and 71.6 minutes for the IPP and malleable penile prosthesis procedure, respectively. No glans ischemia was recorded; however, 1 IPP infection and 1 delayed distal corporeal erosion were recorded. Hematoma or bruising was observed in 23.2% of patients. The modified Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire was completed by 39 (90.7%) patients. Overall, 89.7% would recommend this surgery. Patient satisfaction with straightness and length was 94.9% and 82.1%, respectively. CLINICAL IMPLICATIONS: The described technique helps restoration of penile length and erectile function in patients with complex PD. STRENGTHS & LIMITATIONS: The strength of the study is that it offers a simple, easy-to-apply technique for surgeons to correct shortening and other malformations in patients with ED and complex PD. The study is limited by the small number of patients, the short follow-up period and the performance of the technique by a single high-volume implanter. CONCLUSION: The implantation of a penile prosthesis (malleable or inflatable) together with multiple incisions of the plaque/tunica albuginea and grafting with a collagen fleece is a safe and efficient treatment for patients with complex PD in addition to ED and significant shortening. Fernández-Pascual E, Gonzalez-García FJ, Rodríguez-Monsalve M, et al. Surgical Technique for Complex Cases of Peyronie's Disease With Implantation of Penile Prosthesis, Multiple Corporeal Incisions, and Grafting With Collagen Fleece. J Sex Med 2019;16:323-332.

Penile Prosthesis Surgery: Current Recommendations From the International Consultation on Sexual Medicine.

INTRODUCTION: Penile prosthesis implantation has emerged as a definitive treatment to restore sexual function to the motivated man with erectile dysfunction. Substantial improvements in the design of inflatable devices have been made since they first became available more than four decades ago. AIM: To review the history of the penile prosthesis, the indications, preoperative evaluation, and patient and partner satisfaction. The current approaches to addressing intra- and postoperative complications, provide an understanding of prosthesis infection, and placement of these devices will be reviewed. METHODS: A committee of worldwide experts in this field was assembled during the 2015 International Consultation on Sexual Medicine (ICSM) and performed a systematic review of the peer-reviewed published medical literature pertaining to penile prosthesis. Particular attention was given to higher level trials when available. Recommendations are based upon the Oxford Criteria. MAIN OUTCOME MEASURES: Unfortunately there is limited level 1 and 2 evidence, and where expert opinion was utilized, the decision was unanimous within the committee with a goal of presenting a clinically relevant guideline pertaining to penile prostheses. RESULTS: Penile prosthesis has undergone an evolution over the past 40 years resulting in a more effective and reliable treatment for advanced erectile dysfunction not responding to less invasive methods including oral treatment with PDE5 inhibitors, vacuum erection device, and intracorporal injection therapy. It should be considered an appropriate treatment option for the man who wishes to restore erectile function and who understands the potential risk of mechanical failure and infection, both of which are less common now as a result of improvements made in device design as well as surgical protocols adhered to in the operating room. Patients must be clearly informed of the risks associated with penile prosthesis including mechanical failure, infection, shortening of the penis, change in sensation and configuration of the penis, as well as injury to local structures. Intraoperative complications are unusual but do occur and can usually be addressed intraoperatively to allow placement of the device at the time of initial surgery. Postoperative complications may also be addressed when they occur but may require more advanced reconstructive surgical techniques. Men with Peyronie's disease, corporal fibrosis due to infection, trauma, prior prosthesis explantation, priapism, and men who have undergone construction of a neophallus may require additional advanced maneuvers to obtain optimum results with a penile prosthesis. CONCLUSION: Penile prosthesis remains as an important, viable, and effective treatment for male erectile dysfunction that does not respond to other less invasive approaches or when these approaches are contraindicated or not acceptable to the patient. These devices provide the patient with the ability to engage in penetrative sexual activity without interfering with urination, ejaculation, sensation, or orgasm. Although mechanical failure can occur, the current devices are more reliable as a result of design modifications. Infection remains the most dreaded complication but since the introduction of antibiotic and hydrophilic coatings, infection is less common. Overall, patient and partner satisfaction appear to be reasonably high when a penile prosthesis is used to restore erectile function.

Avanafil for the treatment of erectile dysfunction. An updated review.

OBJECTIVES: Avanafil is a highly selective phosfosdiesterase 5 inhibitor (PDE5 inhibitor), with rapid onset of action, approved by the Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of erectile dysfunction (ED). It had been recently commercialized in Spain. This article presents a detailed review of the available literature, where the safety, tolerability and efficacy of avanafil were evaluated. METHODS: A systematic literature search using the Medline database was performed. The search included the terms Avanafil and erectile dysfunction. The pivotal studies of clinical development of the drug, and also those randomized, double-blind, placebo-controlled, well-designed studies were analyzed. We included those studies published in English up to January 2014. Likewise, studies of the pharmacokinetics and pharmacodynamics of the drug were also included. RESULTS: The avanafil pivotal studies, conducted in general population of patients with ED, patients with Diabetes mellitus type I and II and patients with ED secondary to nerve sparing radical prostatectomy were analyzed. In all these studies, avanafil demonstrated a statistically significant improvement in erectile function (IIEF), and all the coprimary outcomes (SEP2 and SEP3) compared to placebo. Also, a good tolerance profile and few side effects compared to placebo were evident. CONCLUSIONS: Avanafil is a selective PDE5 inhibitors, that is rapidly absorbed and that has a short time to peak response. It found to be effective in randomized, double-blind, placebo-controlled trials conducted in men with erectile dysfunction, including in patients with diabetes mellitus and after radical prostatectomy. It was generally well tolerated across trials, with very few patients withdrawing because of adverse effects. Similarly, avanafil had a significantly lower rate of hemodynamic side effects compared with sildenafil.

[Sexual dysfunction secondary to urethral stricture and urethroplasty]. / Disfunciones sexuales secundarias a la estenosis uretral y a la uretroplastia.

OBJECTIVES: Urethral stenosis is a complex pathology that severely affects the quality of life of patients who suffer it. There are multiple therapeutic options, the main objective of which is to eliminate obstruction and improve symptoms, and consequently maintain or improve the quality of life of the patient. The objective of this article is to perform a systematic review of the literature with the aim to evaluate the results regarding the sexual sphere after urethral surgery. METHODS: We performed a bibliographic search in PubMed, identifying studies that analyzed the results in sexual function after various types of urethroplasties. Preference have been given to those articles evaluating sexual function both preoperative and postoperative, to determine the degree of involvement conditioned by surgery. Fourteen articles have been selected, including those making reference to sexual function (sexual desire, erectile and ejaculatory function). RESULTS: A total of 14 studies were selected to perform the analysis; they were divided into two groups depending of the perspective they have to evaluate results: Use of validated tests for data collection before and after surgery and a second group analyzing more qualitative features of the stenosis making the evaluation of results this way. Site of stenosis is not uniformly distributed in these articles, with predominance of those performing anterior urethra surgery. They have a comprehensive analysis of the various features that may affect directly or indirectly the result of the operation both in the short and long term. CONCLUSIONS: Most articles conclude that specific standardized tools are necessary for this type of pathology, with the aim of obtain results that are more adjusted to urethral surgery. Patient perception of the results of urethroplasty is a parameter that has gained great importance lately. Globally the results of postoperative sexual function are very satisfactory, mainly in young patients. It is important to globally analyze the results and surgical techniques currently in use with the aim to minimize deleterious effects on sexual function; moreover taking into account that the objective of surgery is to try to improve the patient's quality of life.

Penile prosthesis implantation is safe and effective in Peyronie's disease patients with and without erectile dysfunction.

Penile prosthesis (PP) is the mainstay of treatment in Peyronie's disease (PD) with co-existent refractory erectile dysfunction (ED). This study aimed to assess the clinical outcomes of patients who underwent PP as the first-line surgical treatment in PD without ED. A total of 636 patients underwent PP for PD from 2012 to 2022, but only 168 patients who underwent PP as first-line surgical management for PD with or without ED were included in the study. The mean (SD) age of 168 patients was 56.3 years (12.4). The mean curvature of the "PD with ED" group and the "PD without ED" group were 38.2 (5.6) degrees and 42.2 (5.9) degrees. The median (IQR) follow-up was 56.0 months (34.5- 61.4). Most (86.9%) patients underwent 3-piece inflatable PP. An important finding is that 33 patients (19.6%) without ED had undergone PP. Mechanical failure requiring revision surgery was less common in the 'without ED' group than in the ED group (6.8% vs. 10.2%, p 0.04). Most PD patients without ED (87.9%, 29/33) and with ED (88.9%, 120/135) were "satisfied" after PP implantation at six months, as defined by a score of ≥4 on a 5-point Likert scale. If surgery is offered in PD, PP may be considered a safe and effective first-line surgical treatment regardless of the ED, given the acceptable complications and high satisfaction rates. However, this new concept warrants further research.

Efficacy and safety of two disposable circumcision suture devices for circumcision in adults: a prospective comparative multicenter study.

The objective of this study was to evaluate and compare efficacy and safety of two different Disposable circumcision suture devices (DCSDs). A prospective comparative non-randomized multicenter study was performed between November 2019 and February 2023. Patients underwent circumcision using a DCSD (CircCurerTM or the ZSR® device) according to the surgeon preference and device availability. A total of 378 patients were circumcised; 184 using CircCurerTM and 194 patients using ZSR®. No differences in baseline characteristics were observed. CircCurer and ZSR Groups showed similar rates of operative time (7.7 ±2.1 vs 7.3 ±2.0 min), surgical site infection (1.1% Vs 1.5%), edema (13% Vs 8.2%), hematomas (2.7% Vs 1.1%), and postoperative pain (2.5 Vs 2.0 points). ZSR Group had a significantly higher rate of clip fallout (62.9% Vs 38%, p < 0.001). At 2 months, patients of both groups reported a median satisfaction of 9 (8-9) points. Main limitation consist in non-randomized study. DCSDs seem to be effective and safe, with short operative times, uncommon and mild complications, and high patient satisfaction. ZSR® device has a higher rate of spontaneous staple dropout.

Low-intensity extracorporeal shock wave therapy for erectile dysfunction: Myths and realities.

To review the evidence of clinical efficacy of low-intensity extracorporeal shock wave therapy (Li-ESWT) for the treatment of erectile dysfunction (ED). A search on PubMed using Medical Subject Headings terms [((low intensity extracorporeal shockwave therapy) OR (Li-ESWT)) AND (erectile dysfunction)] was conducted in August 2022, to obtain studies on the use of Li-ESWT for the treatment of ED. Its success rate in terms of International Index of Erectile Function-5 (IIEF-5) score and Erection Hardness Score (EHS) improvement was recorded and analysed. A total of 139 articles were reviewed. Overall, 52 studies were included in the final review. 17 studies were on vasculogenic ED, 5 on post pelvic surgery ED, 4 specifically on ED in diabetic patients, 24 on non-specified origin ED and 2 on mixed pathophysiological origin ED. The mean age of patients was 55.87±7.91 (standard deviation) years and the duration of ED was 4.36±2.08 years. The mean IIEF-5 score went from 12.04±2.67 at baseline to 16.12±5.72, 16.30±3.26 and 16.85±1.63 respectively at 3, 6 and 12 months. The mean EHS went from 2.00±0.46 at baseline to 2.58±0.60, 2.75±0.46 and 2.87±0.16 respectively at 3, 6 and 12 months. Li-ESWT may be a safe and efficacy option for the treatment and cure of ED. Further studies are needed to assess which patients are more suitable for this procedure and which Li-ESWT protocol can lead to the best outcomes.

Prognostic role of ECOG performance status in patients with urothelial carcinoma of the upper urinary tract: an international study.

OBJECTIVE: To evaluate the prognostic role of ECOG Performance status (ECOG-PS) in a large multi-institutional international cohort of patients treated with radical nephroureterectomy for upper tract urothelial carcinoma. MATERIALS AND METHODS: Data of 427 patients treated with radical nephroureterectomy at five international institutions in Asia, Europe and Northern America were collected retrospectively from 1987 to 2008. Logistic and Cox regression models were used for univariable and multivariable analyses. RESULTS: ECOG-PS was 0 in 272 of 427 (64%) patients. The median follow-up of the whole cohort was 32 months. The five-year recurrence-free (RFS), cancer-specific (CSS) and overall (OS) survival estimates were 71.7%, 74.9% and 68.5%, respectively, in patients with ECOG-PS 0 compared with 60.1%, 67.8%, and 51.4% respectively, in patients with ECOG-PS ≥1 (P value 0.08 for RFS, 0.43 for CSS, and <0.001 for OS, respectively). On multivariable Cox regression analyses, ECOG-PS was not an independent predictor of either RFS (hazard ratio 1.4; P = 0.107) or CSS (hazard ratio 1.2; P = 0.426) but was an independent predictor of OS (hazard ratio 1.5; P = 0.03). CONCLUSIONS: In this large multicentre international study, ECOG-PS was not significantly associated with RFS and CSS. Conversely we find a strong association with survival 1-month after surgery and OS. Further research is needed to ascertain the additive prognostic role of ECOG-PS in well-designed prospective multicentre studies.