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.
A range of drugs have a direct role in triggering ischaemic priapism. We aimed at identifying: a) which medications are associated with most priapism-reports; and, b) within these medications, ...comparing their potential to elicit priapism through a disproportionality analysis. The FDA Adverse Event Reporting System (FAERS) database was queried to identify those drugs associated the most with priapism reports over the last 5 years. Only those drugs being associated with a minimum of 30 priapism reports were considered. The Proportional Reporting Ratios (PRRs), and their 95% confidence intervals were computed. Out of the whole 2015-2020 database, 1233 priapism reports were identified, 933 of which (75.7%) were associated with 11 medications with a minimum of 30 priapism-reports each. Trazodone, olanzapine and tadalafil showed levels of disproportionate reporting, with a PRR of 9.04 (CI95%: 7.73-10.58), 1.55 (CI95%: 1.27-1.89), and 1.42 (CI95%: 1.10-1.43), respectively. Most (57.5%) of the reports associated with the phosphodiesterase type 5 inhibitors (PDE5Is) were related with concomitant priapism-eliciting drugs taken at the same time and/or inappropriate intake/excessive dosage. Patients taking trazodone and/or antipsychotics need to be aware of the priapism-risk; awareness among prescribers would help in reducing priapism-related detrimental sequelae; PDE5I-intake is not responsible for priapism by itself, when appropriate medical supervision is provided.
Abstract
Background
In the PURE-01 study (NCT02736266), we aimed to evaluate the ability to predict the pathologic complete response (pT0N0) after pembrolizumab by using clinical and tumor ...biomarkers.
Methods
In an open-label, single-arm, phase 2 study, 3 courses of 200 mg pembrolizumab preceding radical cystectomy were administered in patients with T2-4aN0M0 muscle-invasive bladder cancer. The analyses included a comprehensive genomic profiling and programmed cell-death-ligand-1 (PD-L1)–combined positive score assessment (CPS; Dako 22C3 antibody) of pre- and posttherapy samples. Multivariable logistic regression analyses evaluated baseline clinical T stage and tumor biomarkers in association with pT0N0 response. Corresponding coefficients were used to develop a calculator of pT0N0 response based on the tumor mutational burden (TMB), CPS, and the clinical T stage. Decision-curve analysis was also performed. All statistical tests were 2-sided.
Results
From February 2017 to June 2019, 112 patients with biomarker data were enrolled (105 with complete TMB and CPS data). Increasing TMB and CPS values featured a linear association with logistic pT0N0 probabilities (P = .02 and P = .004, respectively). For low TMB values (≤11 mut/Mb, median value, n = 53), pT0N0 probability was not associated with increasing CPS. Conversely, for high TMB values (>11 mut/Mb, n = 52), pT0N0 was statistically significantly associated with higher CPS (P = .004). The C index of the pT0N0 probability calculator was 0.77. On decision-curve analysis, the net benefit of the model was higher than the “treat-all” option within the clinically meaningful threshold probabilities of 40%-50%.
Conclusions
The study presents a composite biomarker-based pT0N0 probability calculator that reveals the complex interplay between TMB and CPS, added to the clinical T stage.
Penile prosthesis implantation continues to represent a reliable solution to address erectile dysfunction when oral medications fail, are not tolerated or are contraindicated, and most typically is ...associated with excellent satisfaction rates and durable results. Despite the dramatic improvements in the prostheses' design, in the surgical instruments and techniques over the years, certain categories of patients still pose a significant surgical challenge. The aim of the current review is to provide a quick and useful practical guidance based on our expertise in the identification and management of the difficult penile prosthesis implantation cases. A narrative review design was here preferred to fulfil our purpose. The search strategy included a range of terms, e.g. penile prosthesis, corporal fibrosis, infection, ischaemic priapism, Peyronie's disease, radical prostatectomy, pelvic surgery. Extensive corporal fibrosis after explantation of an infected device or after prolonged ischaemic priapism may represent the most difficult situations to deal with in penile prosthesis implantation surgery. Penile prosthesis implantation in patients with Peyronie's disease and in those who previously underwent radical prostatectomy also presents with an increased risk of complications. Experienced surgeons need to be able to recognise promptly and manage urethral perforation, cylinder crossover, tunical perforation and erosion, as these complications are more common when dealing with difficult penile prosthesis implantation cases. Applying penile lengthening techniques and principles can be useful in selected cases to ensure better postoperative satisfaction rates, especially in those patients who have experienced a more significant degree of loss of length preoperatively. High-volume-implanting surgeons should always be involved in complex cases to minimise the risk of complications. A thorough preoperative counselling can set realistic patients' expectations in this context, further contributing to postoperative satisfaction.
We assessed the concomitant impact of cigarette smoking and alcohol consumption in men presenting for primary couple's infertility. Data from 189 infertile men were analyzed. Semen analysis, serum ...hormones, and sperm DNA fragmentation (SDF) were obtained. Smoking status was categorized as follows: current nonsmoker (-S), moderate smoker (+MS), and heavy smoker (+HS). Alcohol consumption was categorized as follows: abstainer (-D), moderate drinker (+MD), and heavy drinker (+HD). Descriptive statistics and logistic regression models were applied. Among all the participants, 132 (69.8%), 30 (15.9%), and 27 (14.3%) patients were -S, +MS, and +HS, respectively. In addition, 67 (35.4%), 77 (40.7%) and 45 (23.8%) men were -D, +MD and +HD, respectively. Regarding concomitant habits, 52 (27.5%) patients were nonsmokers and abstainers (-S/-D: Group 1), 91 (48.1%) had at least one recreational habit (-S/+D or +S/-D: Group 2), and 46 (24.3%) were both smokers and drinkers (+S/+D: Group 3). Sperm concentration and progressive motility were lower in +HS and +HD, compared with -S and -D (all P < 0.05), respectively. Similarly, both parameters were significantly lower in Group 3 than Groups 1 and 2 (all P < 0.05). SDF values were higher in Group 3 than Groups 1 and 2 (both P < 0.05). In multivariate analysis, follicle-stimulating hormone (FSH) levels and concomitant +S/+D status were independent predictors of impaired sperm concentration and progressive motility (all P < 0.05). Heavy smoking and heavy drinking were associated with worse seminal parameters than moderate smoking/drinking and nonsmoking/abstaining. When concomitant, +S/+D status has an even greater detrimental effect on semen parameters.
Hormones and cytokines are known to regulate cellular functions in the testes. These biomolecules induce a broad spectrum of effects on various level of spermatogenesis, and among them is the ...modulation of cell junction restructuring between Sertoli cells and germ cells in the seminiferous epithelium. Cytokines and androgens are closely related, and both correct testicular development and the maintenance of spermatogenesis depend on their function. Cytokines also play a crucial role in the immune testicular system, activating and directing leucocytes across the endothelial barrier to the inflammatory site, as well as in increasing their adhesion to the vascular wall. The purpose of this review is to revise the most recent findings on molecular mechanisms that play a key role in male sexual function, focusing on three specific molecular patterns, namely, cytokines, miRNAs, and endothelial progenitor cells. Numerous reports on the interactions between the immune and endocrine systems can be found in the literature. However, there is not yet a multi-approach review of the literature underlying the role between molecular patterns and testicular and sexual function.
The ability to identify clinically significant prostate cancer (csPCa) has dramatically improved with the introduction of multiparametric magnetic resonance imaging (mpMRI). Given the growing ...interest in targeted biopsy and focal therapy, improving our knowledge on the relationship between mpMRI parameters and the ability to predict csPCa multifocality is mandatory.
To assess whether the Prostate Imaging Reporting and Data System (PI-RADS) score for the index lesion (IL) may predict multifocal csPCa undetected by mpMRI.
The study included 343 patients who underwent mpMRI of the prostate with subsequent biopsy between 2014 and 2017 at a single tertiary care referral centre.
Lesions with a PI-RADS v.2 score ≥2 detected at mpMRI (IL) were targeted with a fusion biopsy (Bx) approach (mpMRI-Bx). Moreover, each patient underwent a random extended transrectal ultrasound-guided biopsy (TRUS-Bx) during the same session.
csPCa outside the IL was defined as disease detected at TRUS-Bx with a Gleason score (GS)≥3+4 and equal to or greater than the GS for the IL. The extent of csPCa detected in target and random cores was reported and stratified according to the GS and PI-RADS score for the IL. The probability of diagnosing csPCa outside the IL according to the PI-RADS score was also assessed in multivariable logistic regression analyses (MVA) after accounting for confounders.
The detection rate for csPCa outside the IL was 30%. The detection rate for csPCa at TRUS-Bx was 8% for PI-RADS 2, 15% for PI-RADS 3, 36% for PI-RADS 4, and 58% for PI-RADS 5 lesions (p=0.03). Overall, the median length of csPCa found at TRUS-Bx and thus missed at mpMRI was 2.6mm. However, the length significantly increased with PI-RADS score for the IL, and was 1.8, 2.3, 2.8, and 3.8mm for PI-RADS 2, 3, 4, and 5 lesions, respectively (p=0.03). On MVA, PI-RADS 4 (odds ratio OR 7.6; p=0.008) and PI-RADS 5 scores (OR 17.3; p<0.001) were independent predictors of the presence of csPCa outside the IL. The study is limited by its retrospective design.
Overall, the accuracy of mpMRI in identifying multifocal csPCa is poor, missing low-volume csPCa in approximately 30% of patients. Moreover, the rate and the extent of csPCa undetected by mpMRI significantly increased with the PI-RADS score for the IL, which can thus be considered a proxy for tumour multifocality.
The accuracy of multiparametric magnetic resonance imaging in identifying prostate cancer multifocality is poor. False negative findings were highly related to the PI-RADS score of the index lesion. These findings raise concerns about the indication for targeting the index lesion only when considering prostate biopsy and focal approaches.
The accuracy of multiparametric magnetic resonance imaging in identifying clinically significant prostate cancer multifocality is poor. False negative findings were highly related to the Prostate Imaging Reporting and Data System (PI-RADS) score for the index lesion (IL). Our results raise concerns about the indication for targeting the IL only, especially for higher PI-RADS scores, when considering prostate biopsy and focal approaches.
To describe a technique for open nerve-sparing radical retropubic prostatectomy.
The technique basically implies incising the levator and prostatic fasciae high anteriorly (1 and 11 o’clock ...positions) over the prostate, developing the plane between the prostatic capsule and prostatic fascia, and displacing the neurovascular network localized between the two fasciae laterally. This allows for a minimal-touch dissection of the external urethral sphincter and a very efficient dissection of the neurovascular bundles at the level of membranous urethra and prostatic apex.
Forty-two patients underwent a bilateral nerve-sparing operation and were followed- up for 6 months. Six patients (14.3%) had positive margins: 4 patients had pT2 disease (in all, the positive margin was monofocal) and 2 patients had pT3 disease (both had multifocal positive margins). Continence (defined as being dry or having one pad remain dry for 24hours) was achieved in 44% of patients at catheter removal, and in 60%, 72%, and 90% of patients at the 1-, 3-, and 6-month follow-up visits. Potency (defined as an erectile function domain score ≥26) was obtained in 15%, 40%, and 52% of patients at the 1-, 3-, and 6-month follow-up visits. All patients used a PDE5-inhibitor during the investigation period.
These preliminary results suggest that the high incision of the levator and prostatic fasciae may facilitate efficient preservation of the external urethral sphincter and the neurovascular bundles innervating the corpora cavernosa and the sphincter.
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