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.

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.

PKC Inhibition Improves Human Penile Vascular Function and the NO/cGMP Pathway in Diabetic Erectile Dysfunction: The Role of NADPH Oxidase.

Erectile dysfunction (ED) is a frequent and difficult-to-treat condition in diabetic men. Protein kinase C (PKC) is involved in diabetes-related vascular and cavernosal alterations. We aimed to evaluate the role of PKC in endothelial dysfunction and NO/cGMP impairment associated with diabetic ED in the human corpus cavernosum (CC) and penile resistance arteries (PRAs) and the potential mechanisms involved. Functional responses were determined in the CC and PRAs in patients with non-diabetic ED and diabetic ED undergoing penile prosthesis insertion. PKC activator 12,13-phorbol-dibutyrate (PDBu) impaired endothelial relaxations and cGMP generation in response to acetylcholine in the CC from non-diabetic ED. PDBu also impaired responses to a PDE5 inhibitor, sildenafil, in non-diabetic ED patients. Conversely, a PKC inhibitor, GF109203X, improved endothelial, neurogenic, and PDE5-inhibitor-induced relaxations and cGMP generation only in the CC in diabetic ED patients. Endothelial and PDE5-inhibitor-induced vasodilations of PRAs were potentiated only in diabetes. Improvements in endothelial function in diabetes were also achieved with a specific inhibitor of the PKCß2 isoform or an NADPH-oxidase inhibitor, apocynin, which prevented PDBu-induced impairment in non-diabetic patients. PKC inhibition counteracted NO/cGMP impairment and endothelial dysfunction in diabetes-related ED, potentially improving response to PDE5 inhibition.

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.

European Association of Urology Guidelines on Penile Size Abnormalities and Dysmorphophobia: Summary of the 2023 Guidelines.

CONTEXT: Recommendations regarding the management of penile size abnormalities and dysmorphophobia are important in guiding evidence-based clinical practice. OBJECTIVE: To present a summary of the 2023 European Association of Urology sexual and reproductive health evidence-based recommendations for the management of penile size abnormalities and dysmorphophobia. EVIDENCE ACQUISITION: A broad and comprehensive scoping exercise covering all areas of the guidelines was performed. Databases searched included Medline, EMBASE, and the Cochrane Libraries. A level of evidence and a strength of recommendation were assigned for each recommendation according to the evidence identified. The evidence cutoff date for the 2023 guidelines is June 1, 2022. EVIDENCE SYNTHESIS: Well-structured studies reporting high level of evidence, with standardized PROMS were deficient on penile size abnormalities and dysmorphohobia. A shared definition for short penis/micropenis was also lacking. Categorisation of penile abnormalities according to congenital, acquired, and dysmorphophobic aetiology is deemed compulsory. A detailed medical and psychosexual history and precise measurements of penile size are essential in the diagnostic pathway. Patients with normal penile size who are seeking penile augmentation should be referred for psychological evaluation for potential dysmorphophobic disorders. Penile length and girth enhancements can be achieved via a multitude of treatments, but a personalised management plan is crucial for satisfactory results. Endocrinological therapies, when indicated, are effective in the prepubertal setting only. Vacuum therapy has a limited evidence base in treatment protocols, although acceptable outcomes have been reported for penile traction therapy. Surgical techniques to enhance penile length and girth have limited evidence and should only be proposed after extensive patient counselling. CONCLUSIONS: Management of penile abnormalities and dysmorphophobia is a complex issue with considerable ethical concerns. The adoption of a structured diagnostic and therapeutic pathway is crucial, as recommended in the guidelines. PATIENT SUMMARY: Requests for medical/surgical treatments to increase penis size have increased dramatically worldwide. Several conservative and surgical treatments are available. However, few patients receive clear information on the benefits and possible harms of these treatments. These guidelines aim to provide a structured path to guide both physicians and patients in the selection of appropriate treatment(s) to increase penis size.

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.

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.

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.

STIM/Orai Inhibition as a Strategy for Alleviating Diabetic Erectile Dysfunction Through Modulation of Rat and Human Penile Tissue Contractility and in vivo Potentiation of Erectile Responses.

BACKGROUND: Stromal interaction molecule (STIM)/Orai calcium entry system appears to have a role in erectile dysfunction (ED) pathophysiology but its specific contribution to diabetic ED was not elucidated. AIM: To evaluate STIM/Orai inhibition on functional alterations associated with diabetic ED in rat and human penile tissues and on in vivo erectile responses in diabetic rats. METHODS: Rat corpus cavernosum (RCC) strips from nondiabetic (No DM) and streptozotocin-induced diabetic (DM) rats and human penile resistance arteries (HPRA) and corpus cavernosum (HCC) from ED patients undergoing penile prosthesis insertion were functionally evaluated in organ chambers and wire myographs. Erectile function in vivo in rats was assessed by intracavernosal pressure (ICP) responses to cavernous nerve electrical stimulation (CNES). Expression of STIM/Orai elements in HCC was determined by immunofluorescence and immunoblot. MAIN OUTCOME MEASURES: Functional responses in RCC, HCC and HPRA and STIM/Orai protein expression in HCC. In vivo erectile responses to CNES. RESULTS: Inhibition of Orai channels with YM-58483 (20 µM) significantly reduced adrenergic contractions in RCC but more effectively in DM. Thromboxane-induced and neurogenic contractions were reduced by STIM/Orai inhibition while defective endothelial, neurogenic and PDE5 inhibitor-induced relaxations were enhanced by YM-58483 (10 µM) in RCC from DM rats. In vivo, YM-58483 caused erections and attenuated diabetes-related impairment of erectile responses. YM-58483 potentiated the effects of PDE5 inhibition. In human tissues, STIM/Orai inhibition depressed adrenergic and thromboxane-induced contractions in ED patients more effectively in those with type 2 diabetes. Diabetes was associated with increased expression of Orai1 and Orai3 in ED patients. CLINICAL TRANSLATION: Targeting STIM/Orai to alleviate diabetes-related functional alterations of penile vascular tissue could improve erectile function and potentiate therapeutic effects of PDE5 inhibitors in diabetic ED. STRENGTHS AND LIMITATIONS: Improving effects of STIM/Orai inhibition on diabetes-related functional impairment was evidenced in vitro and in vivo in an animal model and validated in human tissues from ED patients. Functional findings were complemented with expression results. Main limitation was low numbers of human experiments due to limited human tissue availability. CONCLUSIONS: STIM/Orai inhibition alleviated alterations of functional responses in vitro and improved erectile responses in vivo in diabetic rats, potentiating the effects of PDE5 inhibition. STIM/Orai inhibition was validated as a target to modulate functional alterations of human penile vascular tissue in diabetic ED where Orai1 and Orai3 channels were upregulated. STIM/Orai inhibition could be a potential therapeutic strategy to overcome poor response to conventional ED therapy in diabetic patients. Sevilleja-Ortiz A, El Assar M, García-Gómez B, et al. STIM/Orai Inhibition as a Strategy for Alleviating Diabetic Erectile Dysfunction Through Modulation of Rat and Human Penile Tissue Contractility and in vivo Potentiation of Erectile Responses. J Sex Med 2022;19:1733-1749.

Conservative and medical treatments of non-sickle cell disease-related ischemic priapism: a systematic review by the EAU Sexual and Reproductive Health Panel.

Conservative and medical treatments are considered the first step in ischemic priapism (IP) management, although there is no clear evidence regarding their efficacy. We conducted a systematic review on behalf of the EAU Guidelines panel on Sexual and Reproductive health to analyse the available evidence on the efficacy and safety of conservative and medical treatment for non-sickle cell disease-related IP. Databases searched for relevant literature investigating efficacy and safety of conservative measures and medical treatment for IP included Medline, EMBASE, Cochrane Libraries and clinicaltrial.gov published up to September 2021. Overall, 41 retrospective, 3 prospective single-arm studies and 3 randomized controlled trials met the inclusion criteria. Intracavernous injection with sympathomimetic (ICIs) agents were the most frequently utilized treatment with efficacy ranging from 0 to 100% of cases. The combination of ICIs with corporeal aspiration with or without irrigation with saline was successful in 70 to 100% of cases. Oral treatment with ß2 receptor agonist (e.g., terbutaline) showed mild to moderate efficacy. Conservative methods including ice pack, exercise, cold enema and ejaculation depicted lower effectiveness in resolving priapism (1-55%). Longer time interval from the onset to the resolution of IP was associated with higher rate of erectile dysfunction at follow-up (30-70%), especially after 24 h.

mpMRI-US Fusion-Guided Targeted Cryotherapy in Patients with Primary Localized Prostate Cancer: A Prospective Analysis of Oncological and Functional Outcomes.

Targeted therapy (TT) for prostate cancer (PCa) aims to ablate the malignant lesion with an adequate margin of safety in order to obtain similar oncological outcomes, but with less toxicity than radical treatments. The main aim of this study was to evaluate the recurrence rate (RR) in patients with primary localized PCa undergoing mpMRI/US fusion targeted cryotherapy (FTC). A secondary objective was to evaluate prostate-specific antigen (PSA) as a predictor of recurrences. We designed a prospective single-center single-cohort study. Patients with primary localized PCa, mono or multifocal lesions, PSA ≤ 15 ng/mL, and a Gleason score (GS) ≤ 4 + 3 undergoing FTC were enrolled. RR was chosen as the primary outcome. Recurrence was defined as the presence of clinically significant prostate cancer in the treated areas. PSA values measured at different times were tested as predictors of recurrence. Continuous variables were assessed with the Bayesian t-test and categorical assessments with the chix-squared test. Univariate and logistic regression assessment were used for predictions. A total of 75 cases were included in the study. Ten subjects developed a recurrence (RR: 15.2%), while fifty-six (84.8%) patients showed a recurrence-free status. A %PSA drop of 31.5% during the first 12 months after treatment predicted a recurrence with a sensitivity of 53.8% and a specificity of 79.2%. A PSA drop of 55.3% 12 months after treatment predicted a recurrence with a sensitivity of 91.7% and a specificity of 51.9%. FTC for primary localized PCa seems to be associated with a low but not negligible percentage of recurrences. Serum PSA levels may have a role indicating RR.

Hyperbaric oxygen therapy as adjuvant treatment for surgical site infections after male-to-female gender affirmation surgery: A 10-year experience.

INTRODUCTION: Several urological conditions that share an impairment of tissue oxygenation can benefit from hyperbaric oxygen therapy; limited evidence is available of its impact on patients undergoing male-to-female gender affirmation surgery. AIM: To evaluate the efficacy and safety of hyperbaric oxygen therapy as adjuvant treatment for surgical site infections in patients undergoing male-to-female gender affirmation surgery. METHODS: This research was conducted as an observational retrospective study. Patients undergoing male-to-female gender affirmation surgery at the principal investigators' institution from January 2009 to September 2019, with a discharge diagnosis of complicated superficial or deep wound infections, were included. All patients underwent standard management of wound infection. Subjects received/not-received hyperbaric oxygen therapy at the surgeon's discretion and were assigned to the hyperbaric oxygen therapy versus non-hyperbaric oxygen therapy group accordingly. Complete wound healing rate (primary outcome), duration of antibiotic therapy, perineal drain time, bladder catheter time, and hospital stay were recorded. All adverse events that occurred during the study period were described. RESULTS: A total of 156 patients underwent male-to-female gender affirmation surgery in the study period. Thirty-three patients were enrolled. Fifteen subjects belonged to the hyperbaric oxygen therapy group, the other 18 to the non-hyperbaric oxygen therapy group. No statistically significant differences were found between the two groups at baseline. Penile inversion vaginoplasty and intestinal vaginoplasty were performed in nine (60%) and six (40%) patients of the hyperbaric oxygen therapy group. Only penile inversion vaginoplasty was performed in subjects of the non-hyperbaric oxygen therapy group. Complete wound healing was obtained in 15 patients (100%) of the hyperbaric oxygen therapy group and 17 patients (94.4%) of the non-hyperbaric oxygen therapy group (p = 0.35). Duration of antibiotic therapy, perineal drain time, bladder catheter time, and hospital stay were significantly lower in the hyperbaric oxygen therapy group (p < 0.05). CONCLUSION: Our preliminary data suggest a role of hyperbaric oxygen therapy as adjuvant treatment for surgical site infection in patients undergoing male-to-female gender affirmation surgery. Randomized controlled trials properly powered are needed to confirm our findings.

Risk Factors for Revision After Artificial Urinary Sphincter Implantation in Male Patients With Stress Urinary Incontinence: A 10-Year Retrospective Study.

PURPOSE: To evaluate the preoperative and intraoperative risk factors for revision after artificial urinary sphincter (AUS) implantation in male patients with stress urinary incontinence (SUI). METHODS: A retrospective analysis from a prospectively maintained database was performed. Male patients, with moderate-tosevere SUI, undergoing AUS implantation were included. All patients underwent placement of AMS 800. Cause of revision, type of revision, and time to revision were recorded. Multivariable analyzes were performed using a logistic regression to investigate the risk factors. Competing risk analysis according to Fine-Gray model was used to study time to event data. RESULTS: A total of 70 patients were included. Revision surgery was performed in 22 of 70 patients (31.4%), after a median (interquartile range) time of 26.5 months (6.5-39.3 months). Overall, 19 of 22 repairs (86.4%) and 3 of 22 explants (13.6%) were recorded. Mechanical dysfunction, urethral erosion, urethral atrophy, and device infection were the causes of revision in 11 of 22 (50.0%), 6 of 22 (27.3%), 3 of 22 (13.6%), and 2 of 22 patients (9.1%). Vesicourethral anastomosis stenosis (P=0.02), urethral cuff size of 3.5 cm (P=0.029), and dual implantation (P=0.048) were independent predictors for revision. Vesicourethral anastomosis stenosis (P=0.01) and urethral cuff size of 3.5 cm (P=0.029) predicted a lower survival of the AUS. CONCLUSION: The vesicourethral anastomosis stenosis, urethral cuff size of 3.5 cm, and dual implantation are independent predictors for revision after AUS implantation. However, only the vesicourethral anastomosis stenosis and urethral cuff size of 3.5 cm predict a lower survival of AUS.

Combination therapy with topical alprostadil and phosphodiesterase-5 inhibitors after failure of oral therapy in patients with erectile dysfunction: a prospective, two-arm, open-label, non-randomized study.

Phosphodiesterase type 5 inhibitors (PDE5Is) are the first-line therapeutic option for erectile dysfunction (ED), while second-line therapy includes the alprostadil. Due to the different pharmacodynamic mechanism of PDE5Is and alprostadil, a synergistic action is conceivable when they are administered in combination. The aim of present study was to evaluate the efficacy and safety of combination therapy with PDE5I and topical alprostadil in patients with ED non-responders to PDE5I alone. We designed a prospective, two-arm, open-label, non-randomized study. Patients over 18 years old, with a stable sexual relationship for at least 6 months, and ED non-responders to PDE5I monotherapy were included in the study. At baseline the variables assessed were 5-item version of the International Index of Erectile Function (IIEF-5), and Sexual Encounter Profile Questions 2 and 3 (SEP-2 and SEP-3). In addition, all subjects underwent penile dynamic duplex ultrasonography. All patients were assigned to the monotherapy group (Group A) or combination therapy group (Group B) based on their preference. Topical alprostadil 300 µg/100 mg (Virirec®) was the treatment assigned to Group A, while the combination therapy with the last PDE5I taken (at the maximum recommended dose) plus topical alprostadil 300 µg/100 mg (Virirec®) was assigned to Group B. After 3 months from assignment to groups were evaluated IIEF-5, SEP-2 and SEP-3 regarding the last sexual intercourse, and Global Assessment Questionnaire-Questions 1 and 2 (GAQ-1 and GAQ-2). All adverse events (AEs) that occurred during the study period were recorded. A total of 170 patients were included in the study (72 in Group A and 98 in Group B). Fifty-two patients were previously treated with sildenafil 100 mg (30.6%), 6 with vardenafil 20 mg (3.5%), 56 with tadalafil 20 mg (32.9%), and 56 with avanafil 200 mg (32.9%). No significant differences among the study groups were found at baseline (p > 0.05). The mean IIEF-5 score increased significantly in Group B after treatment compared to baseline (12.4 ± 3.4 vs. 17.1 ± 4.5; p < 0.001), conversely patients in Group A showed no significant increase (12.2 ± 2.5 vs. 12.7 ± 3.1; p = 0.148). The number of affirmative responses to SEP-2 was significantly higher after treatment compared to baseline only in Group B (57 vs. 78; p < 0.001). The number of affirmative responses to SEP-3 was significantly higher after treatment compared to baseline in both groups (p < 0.001). The number of affirmative responses to GAQ-Q1 and GAQ-Q2 was significantly higher in Group B compared to Group A (p < 0.001). A total of 59 (34.7%) patients experienced AEs. They were mild, self-limited, and did not cause discontinuation of treatment. No episode of priapism was recorded. No statistically significant difference was recorded between the AEs of the two groups, except for facial flushing that was reported only in Group B (p = 0.021). The combination therapy with topical alprostadil and PDE5I seems to be more effective than topical alprostadil alone without worsening the safety of the treatment.

The Role of Prostate-specific Membrane Antigen Positron Emission Tomography/Magnetic Resonance Imaging in Primary and Recurrent Prostate Cancer: A Systematic Review of the Literature.

CONTEXT: Prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) is a novel imaging technique with several potential applications in the prostate cancer (PCa) setting. OBJECTIVE: To perform a systematic review of the current evidence regarding the diagnostic performance of PSMA PET/MRI in patients with primary and recurrent PCa. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the MEDLINE and Cochrane Library databases was performed in October 2020. The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Studies were deemed eligible if they assessed patients with primary or recurrent PCa (P) undergoing PSMA PET/MRI (I) with or without comparison with other imaging techniques (C) in order to evaluate its diagnostic performance (O). Retrospective and prospective primary clinical studies were included. Results of previous meta-analyses were reported. EVIDENCE SYNTHESIS: A total of 23 original articles and three meta-analyses were included. Limited evidence on PSMA PET/MRI is available, especially in the setting of partial gland ablation. PET/MRI can be an effective imaging modality for detecting primary PCa, showing higher accuracy than multiparametric MRI alone. It provides accurate local staging of primary PCa; however, there are contradictory results in this context when its performance is compared with other imaging techniques. PET/MRI also shows high performance for restaging and detecting tumor recurrence, even at low prostate-specific antigen levels. CONCLUSIONS: PSMA PET/MRI could represent a valuable tool in the management of patients with primary and recurrent PCa. No specific recommendations can be provided. PATIENT SUMMARY: Encouraging data regarding the benefits of prostate-specific membrane antigen positron emission tomography/magnetic resonance imaging in patients with prostate cancer are emerging from the literature.

Is there a line between ethics and market competition? Lights and shades of the withdrawal of collagenase treatment for Peyronie's disease.

Peyronie's disease treatments is changing again due the interruption of Xiapex® distrubution in Europe. There are many reasons that can be referred to this event. In this editorial we would like to shed light on the current cost items relating to treatment with collagenase clostridium histolyticum (CCH). The inaccessibility of the drug has seen both an increase in surgery for the treatments of both PD and Dupuytren's disease and an interruption of therapies in patients who had not completed their therapeutic cycle. Considering the aforementioned concerns, we would like to invite researchers dealing with PD to conduct studies with the available CCH products in collaboration with the drug companies in order to give again an efficacious treatment for PD.

Peyronie's Disease Questionnaire (PDQ): Spanish translation and validation.

The Peyronie's Disease Questionnaire (PDQ) is a 15-question self-reported questionnaire that evaluates the severity and physical and psychosexual issues of Peyronie's disease (PD) symptoms in three scales: "psychological and physical symptoms," "penile pain," and "symptom bother." Previous studies validated the PDQ US version and confirmed its test-retest reliability and responsiveness. The aim is to translate and validate the Spanish version of the PDQ to be used in the clinical practice and in PD research studies in Spain. A non-interventional, observational study with 160 PD patients was conducted. Patients included from four healthcare centers in Spain and completed the PDQ in two study visits separated for a period of 4-7 days from March 2018 to June 2019. Patients received no type of treatment or intervention. Different statistical tests were applied to the data in order to validate the structural and construct of the PDQ, as well as its internal reliability, temporal stability reliability, reliability between observers, and test-retest reliability. Cronbach's alpha over 0.9 showed good internal consistency. We found an ICC agreement of 0.82 (test-retest) for the three scales of the Spanish version of the PDQ, which demonstrates good reliability. When comparing Visit 1 and Visit 2 questionnaires mean scores, the PDQ showed non-significant differences, as expected because no intervention or treatment was administered to the patients between visits. Translation and validation of the PDQ for the Spanish population makes available a valid, useful, and reliable tool to properly evaluate quality of life of men suffering PD.