Assessment of Patient Risk Profiles by a Male Sexual Health Direct-to-Consumer Prescription Platform: A Cross-Sectional Study.

Background: Direct-to-consumer (DTC) online prescription platforms (OPP) for sexual health represent a potential paradigm shift in the diagnosis and treatment for sexual dysfunctions in the way men seek care. Knowledge of patients' risk profile using these platforms is limited. Aim: To assess risk profiles of patients reaching out to health care professionals through their DTC. Methods: Anonymized data originally collected between February 2021 to May 2022 by a DTC platform in the men's health care space were retrospectively analyzed. Data included the content of patient requests through a communication function, as well as the corresponding responses by the attending physician on staff. Each request was then assessed by two independent urologists and categorized by the level of the risk profile as well as the need to refer the patient to further medical evaluation. Results: Of 585 patient requests, 531 (90.8%) were classified as low risk. In the high-risk group, 32 patients were recommended to schedule an urgent appointment at a specialist. Only three patients (0.5%) were advised to seek emergency care. The overall referral rate for both risk groups was 52.3%. The requests of 279 patients (47.7%) were assessed as digitally treatable. Almost all patients who were digitally treatable were low risk. Side effects accounted for only 9.6% of all requests in the low-risk group, compared with 46.3% in the high-risk group. Conclusion: Overall, low-risk levels in the requests of patients using a DTC platform were reported, with almost half of them suitable to be solved digitally, whereas the other half required referral to an in-person specialist.

In vivo Temperature Assessment during Holmium Laser Enucleation of the Prostate.

INTRODUCTION: Holmium laser enucleation of the prostate (HoLEP) has become popular worldwide for the surgical treatment of benign prostate hyperplasia. Holmium laser is considered an ideal transurethral thermomechanical device for enucleating the prostate. Although there is evidence on Ho:YAG laser-related heat generation, the studies mainly investigated ex vivo temperature generation during holmium laser lithotripsy. In this in vivo study, we aimed to assess for the first time the real-time heat generated during HoLEP. METHODS: Fifteen HoLEP procedures were included. The study was conducted over a time period of 16 months. To investigate the temperature generation, a preoperatively inserted rectal temperature probe and a temperature sensor within a suprapubic bladder catheter were used to record the temperature change during enucleation and coagulation. RESULTS: The mean values of the temperature change during the laser enucleation and coagulation were -0.35 ± 0.203 K (IQR: 0.23) and +0.14 ± 0.259 K (IQR: 0.3), respectively, in rectal measurements. Temperature differences during laser use and coagulation were <+1 K and <+5 K, respectively, in bladder measurements. We measured no temperature >37.1°C during the procedures and no temperature values considered harmful to the human body. CONCLUSION: Sufficient irrigation flow rates and irrigation monitoring during HoLEP are obligatory. To prevent a high and uncontrolled temperature rise, the surgeon or operating room staff should pay attention to the irrigation's continuity.

Living systematic review and meta-analysis of the prostate MRI diagnostic test with Prostate Imaging Reporting and Data System (PI-RADS) assessment for the detection of prostate cancer: study protocol.

INTRODUCTION: The Prostate Imaging Reporting and Data System (PI-RADS) standardises reporting of prostate MRI for the detection of clinically significant prostate cancer. We provide the protocol of a planned living systematic review and meta-analysis for (1) diagnostic accuracy (sensitivity and specificity), (2) cancer detection rates of assessment categories and (3) inter-reader agreement. METHODS AND ANALYSIS: Retrospective and prospective studies reporting on at least one of the outcomes of interest are included. Each step that requires literature evaluation and data extraction is performed by two independent reviewers. Since PI-RADS is intended as a living document itself, a 12-month update cycle of the systematic review and meta-analysis is planned.This protocol is in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocols statement. The search strategies including databases, study eligibility criteria, index and reference test definitions, outcome definitions and data analysis processes are detailed. A full list of extracted data items is provided.Summary estimates of sensitivity and specificity (for PI-RADS ≥3 and PI-RADS ≥4 considered positive) are derived with bivariate binomial models. Summary estimates of cancer detection rates are calculated with random intercept logistic regression models for single proportions. Summary estimates of inter-reader agreement are derived with random effects models. ETHICS AND DISSEMINATION: No original patient data are collected, ethical review board approval, therefore, is not necessary. Results are published in peer-reviewed, open-access scientific journals. We make the collected data accessible as supplemental material to guarantee transparency of results. PROSPERO REGISTRATION NUMBER: CRD42022343931.

Temperature assessment study of ex vivo holmium laser enucleation of the prostate model.

PURPOSE: There isscarce evidence to date on how temperature develops during holmium laser enucleation of the prostate (HoLEP). We aimed to determine the potential heat generation during HoLEP under ex vivo conditions. METHODS: We developed two experimental setups. Firstly, we simulated HoLEP ex vivo using narrow-neck laboratory bottles mimicking enucleation cavities and a prostate resection trainer. Seven temperature probes were placed at different locations in the experimental setup, and the heat generation was measured separately during laser application. Secondly, we simulated high-frequency current-based coagulation of the vessels using a roller probe. RESULTS: We observed that the larger the enucleated cavity, the higher the temperature rises, regardless of the irrigation flow rate. The highest temperature difference with an irrigation flow was approximately + 4.5 K for a cavity measuring 100ccm and a 300 ml/min irrigation flow rate. The higher flow rate generates faster removal of the generated heat, thus cooling down the artificial cavity. Furthermore, the temperature differences at different irrigation flow rates (except at 0 ml/min) were consistently below 5 K. Within the resection trainer, the temperature increase with and without irrigation flow was approximately 0.5 K and 3.0 K, respectively. The mean depth of necrosis (1084 ± 176 µm) achieved by the roller probe was significantly greater when using 144 W energy. CONCLUSION: Carefully adjusted irrigation and monitoring during HoLEP are crucial when evacuating the thermal energy generated during the procedure. We believe this study of ours provides evidence with the potential to facilitate clinical studies on patient safety.

Prostatic Artery Embolization for Treatment of Lower Urinary Tract Symptoms: A Markov Model-Based Cost-Effectiveness Analysis.

PURPOSE: The aim of this study was to investigate whether prostatic artery embolization (PAE) can be considered a long-term cost-effective treatment option in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia in comparison to transurethral resection of the prostate (TURP). METHODS: The in-hospital costs of PAE and TURP in the United States were obtained from a recent cost analysis. Clinical outcomes including nature and rate of adverse events for TURP and PAE along with rates of retreatment because of complications or clinical failure were obtained from peer-reviewed literature. A decision tree-based Markov model was created, analyzing long-term cost-effectiveness for TURP and PAE from a US health care sector perspective. Cost-effectiveness over a time frame of 5 years was estimated while assuming a willingness to pay of $50,000 per quality-adjusted life-year (QALY). The primary outcome was incremental cost-effectiveness ratio. RESULTS: PAE resulted in overall cost of $6,464.92 and an expected outcome of 4.566 QALYs. In comparison, TURP cost $9,221.09 and resulted in expected outcome of 4.577 QALYs per treatment. The incremental cost-effectiveness ratio for TURP was $247,732.65 per QALY. On the basis of the willingness-to-pay threshold, PAE is cost effective compared with TURP. CONCLUSIONS: On the basis of our model, PAE in comparison with TURP can be regarded as a cost-effective treatment option for patients with lower urinary tract symptoms within the US health care system.

Cancer detection rates of the PI-RADSv2.1 assessment categories: systematic review and meta-analysis on lesion level and patient level.

BACKGROUND: The Prostate Imaging Reporting and Data System, version 2.1 (PI-RADSv2.1) standardizes reporting of multiparametric MRI of the prostate. Assigned assessment categories are a risk stratification algorithm, higher categories indicate a higher probability of clinically significant cancer compared to lower categories. PI-RADSv2.1 does not define these probabilities numerically. We conduct a systematic review and meta-analysis to determine the cancer detection rates (CDR) of the PI-RADSv2.1 assessment categories on lesion level and patient level. METHODS: Two independent reviewers screen a systematic PubMed and Cochrane CENTRAL search for relevant articles (primary outcome: clinically significant cancer, index test: prostate MRI reading according to PI-RADSv2.1, reference standard: histopathology). We perform meta-analyses of proportions with random-effects models for the CDR of the PI-RADSv2.1 assessment categories for clinically significant cancer. We perform subgroup analysis according to lesion localization to test for differences of CDR between peripheral zone lesions and transition zone lesions. RESULTS: A total of 17 articles meet the inclusion criteria and data is independently extracted by two reviewers. Lesion level analysis includes 1946 lesions, patient level analysis includes 1268 patients. On lesion level analysis, CDR are 2% (95% confidence interval: 0-8%) for PI-RADS 1, 4% (1-9%) for PI-RADS 2, 20% (13-27%) for PI-RADS 3, 52% (43-61%) for PI-RADS 4, 89% (76-97%) for PI-RADS 5. On patient level analysis, CDR are 6% (0-20%) for PI-RADS 1, 9% (5-13%) for PI-RADS 2, 16% (7-27%) for PI-RADS 3, 59% (39-78%) for PI-RADS 4, 85% (73-94%) for PI-RADS 5. Higher categories are significantly associated with higher CDR (P < 0.001, univariate meta-regression), no systematic difference of CDR between peripheral zone lesions and transition zone lesions is identified in subgroup analysis. CONCLUSIONS: Our estimates of CDR demonstrate that PI-RADSv2.1 stratifies lesions and patients as intended. Our results might serve as an initial evidence base to discuss management strategies linked to assessment categories.

Real-world data and treatment patterns of patients with lower urinary tract symptoms due to benign prostatic hyperplasia in Germany: an observational study using health insurance claims data.

PURPOSE: Benign prostatic hyperplasia (BPH) is associated with lower urinary tract symptoms (LUTS), representing one of the most common urological conditions. However, insights into the actual healthcare of this patient cohort in Germany are scarce. We aimed to retrospectively analyse management patterns of patients with LUTS in Germany using health insurance claims databases. METHODS: A retrospective, longitudinal cohort analysis was conducted obtaining claims data from the German InGef health insurance database containing approximately five million member-records from over 60 nationwide statutory health insurances. First, a cross-sectional prevalence analysis was performed on all individuals with a diagnosis on LUTS (ICD-10 GM N40) in 2018. Second, a longitudinal analysis of individuals with either a newly started BPH medication or initial BPH surgery who were indexed in 2014 and followed-up for 4 years. RESULTS: In 2018, 132,386 (6.7%) prevalent BPH patients were identified from 1,979,916 continuously insured males. A potential overcoding bias could not be assessed which may influence the outpatient sector estimation. 10,361 (0.7%) patients were identified with incident BPH medication and 1768 (0.1%) patients with incident BPH surgery out of 1,575,604 males (2013-2018). Alpha-blockers were the drug of choice (95.6%) in the first year. Half of patients received specific BPH medications four years after index, while almost 98% of initial BPH surgeries were performed within the inpatient setting. TURP was the most frequent surgical intervention (76%). CONCLUSIONS: A widespread diffusion of alternative individualized minimally invasive approaches in the outpatient sector might address pharmacotherapy discontinuation and patient-access barriers to other treatments.

Adherence to European Association of Urology and National Comprehensive Cancer Network Guidelines Criteria for Inguinal and Pelvic Lymph Node Dissection in Penile Cancer Patients-A Survey Assessment in German-speaking Countries on Behalf of the European Prospective Penile Cancer Study Group.

BACKGROUND: Urologists' adherence to European Association of Urology and National Comprehensive Cancer Network guideline recommendations to perform inguinal (ILND) and pelvic (PLND) lymph node dissection in penile cancer (PC) patients is not known. OBJECTIVE: To assess a German-speaking European cohort of urologists based on their criteria to perform ILND and PLND in PC patients. DESIGN, SETTING, AND PARTICIPANTS: A 14-item survey addressing general issues of PC treatment was developed and sent to 45 clinical centers in Germany (n = 34), Austria (n = 8), Switzerland (n = 2), and Italy (n = 1). INTERVENTION: Two of the 14 questions assessed the criteria to perform ILND and ipsilateral PLND. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Correct responses for ILND and PLND criteria were assessed. Based on a multivariate logistic-regression-model, criteria independently predicting guideline adherence were identified. RESULTS AND LIMITATIONS: In total, 557 urologists participated in the survey, of whom 43.5%, 19.3%, and 37.2% were residents in training, certified, and in leading positions, respectively. ILND and PLND criteria were correctly identified by 35.2% and 23.9%, respectively. Of the participants, 23.3% used external sources for survey completion. The use of auxiliary tools (odds ratio [OR] 1.57; p[bootstrapped] = 0.028) and participants outside of Germany (OR 0.56; p[bootstrapped] = 0.006) were predictors of ILND guideline adherence. The number of PC patients treated yearly (p = 0.012; OR 1.06) and the use of auxiliary tools (p < 0.001; OR 5.88) were predictors of PLND adherence. Department size, healthcare status, professional status, and responsibility for PC surgery did not predict endpoints. Limitations include sample size and results in comparison with retrospective studies. CONCLUSIONS: Our results demonstrate overall suboptimal knowledge of the correct indications to perform ILND and PLND in PC patients among the surveyed urologists. We propose that governments and healthcare providers should be encouraged to centralize PC management. PATIENT SUMMARY: The management of inguinal and pelvic lymph nodes is crucial for the survival of penile cancer patients. Disease rarity mandates referral to clinical practice guidelines for appropriate treatment selection.

Radiomics Applications in Renal Tumor Assessment: A Comprehensive Review of the Literature.

Radiomics texture analysis offers objective image information that could otherwise not be obtained by radiologists' subjective radiological interpretation. We investigated radiomics applications in renal tumor assessment and provide a comprehensive review. A detailed search of original articles was performed using the PubMed-MEDLINE database until 20 March 2020 to identify English literature relevant to radiomics applications in renal tumor assessment. In total, 42 articles were included in the analysis and divided into four main categories: renal mass differentiation, nuclear grade prediction, gene expression-based molecular signatures, and patient outcome prediction. The main area of research involves accurately differentiating benign and malignant renal masses, specifically between renal cell carcinoma (RCC) subtypes and from angiomyolipoma without visible fat and oncocytoma. Nuclear grade prediction may enhance proper patient selection for risk-stratified treatment. Radiomics-predicted gene mutations may serve as surrogate biomarkers for high-risk disease, while predicting patients' responses to targeted therapies and their outcomes will help develop personalized treatment algorithms. Studies generally reported the superiority of radiomics over expert radiological interpretation. Radiomics provides an alternative to subjective image interpretation for improving renal tumor diagnostic accuracy. Further incorporation of clinical and imaging data into radiomics algorithms will augment tumor prediction accuracy and enhance individualized medicine.

Efficacy and Safety of Combination Pharmacotherapy for Patients with Overactive Bladder: A Rapid Evidence Assessment.

CONTEXT: Oral pharmacotherapy consisting of antimuscarinics, ß3-adrenoreceptor agonists, or combinations of these agents forms the mainstay of overactive bladder (OAB) management. OBJECTIVE: To evaluate the efficacy and safety of combination therapy in patients with OAB. EVIDENCE ACQUISITION: A literature search was conducted in June 2018 using Embase, MEDLINE, and Cochrane databases via Ovid and relevant congress abstracts. Studies reporting the efficacy/safety of two antimuscarinics or a ß3-adrenoreceptor agonist plus an antimuscarinic were included. EVIDENCE SYNTHESIS: Publications reported on clinical efficacy, safety, and health-related quality of life (HRQoL) for mirabegron (M) plus solifenacin (S) from three 12-wk randomised controlled trials (RCTs)-SYMPHONY, SYNERGY, and BESIDE-and a 12-mo RCT, SYNERGY II. SYMPHONY reported statistically significant improvements in clinical symptoms and HRQoL with combination therapy versus solifenacin 5 mg (S5) and placebo. In SYNERGY, there were consistent improvements in urinary incontinence (UI) episodes/24 h and micturitions/24 h (coprimary endpoints), and in secondary efficacy parameters with mirabegron 25 mg (M25) + S5 and mirabegron 50 mg (M50) + S5 versus respective monotherapies. In patients with an inadequate response to S5 monotherapy (BESIDE), greater improvements in UI (primary endpoint) were noted for M50 + S5 versus S5 (p = 0.001). Combination therapy was noninferior to solifenacin 10 mg (S10) for reduction in UI and superior to S10 for improvement in micturition frequency (p < 0.001), and resulted in greater improvements from baseline in OAB-5 Dimension scores versus S5 and S10 (p < 0.01). In SYNERGY II, clinically meaningful and sustained improvements in clinical outcomes were observed for M50 + S5 versus M50 or S5. Combination therapy was well tolerated in all four trials. The incidence of adverse events (AEs) was similar across groups, and there were no notable differences in the incidence of specific AEs. Positive efficacy outcomes were observed in five studies of dual antimuscarinic therapy (trospium + solifenacin). CONCLUSIONS: Mirabegron plus solifenacin provides effective, well-tolerated treatment for patients with OAB. Limited data for dual antimuscarinic therapy suggest a benefit in patients with moderate-to-severe symptoms. PATIENT SUMMARY: Overactive bladder (OAB) is treated with medicines called antimuscarinics, such as solifenacin, propiverine, or trospium, or another ß-adrenoreceptor agonist medicine called mirabegron, which works in a different way. We looked at published scientific studies of patients with OAB treated with mirabegron plus solifenacin together, or with two antimuscarinics. We found that mirabegron plus solifenacin can help reduce symptoms and improve quality of life. Patients tolerate this treatment well, with few patients experiencing side effects.

A comparative assessment of prostate positioning guided by three-dimensional ultrasound and cone beam CT.

BACKGROUND: The accuracy of the Elekta Clarity™ three-dimensional ultrasound system (3DUS) was assessed for prostate positioning and compared to seed- and bone-based positioning in kilo-voltage cone-beam computed tomography (CBCT) during a definitive radiotherapy. METHODS: The prostate positioning of 6 patients, with fiducial markers implanted into the prostate, was controlled by 3DUS and CBCT. In total, 78 ultrasound scans were performed trans-abdominally and compared to bone-matches and seed-matches in CBCT scans. Setup errors detected by the different modalities were compared. Systematic and random errors were analysed, and optimal setup margins were calculated. RESULTS: The discrepancy between 3DUS and seed-match in CBCT was -0.2 ± 2.7 mm laterally, -1.9 ± 2.3 mm longitudinally and 0.0 ± 3.0 mm vertically and significant only in longitudinal direction. Using seed-match as reference, systematic errors of 3DUS were 1.3 mm laterally, 0.8 mm longitudinally and 1.4 mm vertically, and random errors were 2.5 mm laterally, 2.3 mm longitudinally, and 2.7 mm vertically. No significant difference could be detected for 3DUS in comparison to bone-match in CBCT. CONCLUSIONS: 3DUS is feasible for image guidance for patients with prostate cancer and appears comparable to CBCT based image guidance in the retrospective study. While 3DUS offers some distinct advantages such as no need of invasive fiducial implantation and avoidance of extra radiation, its disadvantages include the operator dependence of the technique and dependence on sufficient bladder filling. Further study of 3DUS for image guidance in a large patient cohort is warranted.

EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction.

CONTEXT: Lower urinary tract symptoms (LUTS) represent one of the most common clinical complaints in adult men and have multifactorial aetiology. OBJECTIVE: To develop European Association of Urology (EAU) guidelines on the assessment of men with non-neurogenic LUTS. EVIDENCE ACQUISITION: A structured literature search on the assessment of non-neurogenic male LUTS was conducted. Articles with the highest available level of evidence were selected. The Delphi technique consensus approach was used to develop the recommendations. EVIDENCE SYNTHESIS: As a routine part of the initial assessment of male LUTS, a medical history must be taken, a validated symptom score questionnaire with quality-of-life question(s) should be completed, a physical examination including digital rectal examination should be performed, urinalysis must be ordered, post-void residual urine (PVR) should be measured, and uroflowmetry may be performed. Micturition frequency-volume charts or bladder diaries should be used to assess male LUTS with a prominent storage component or nocturia. Prostate-specific antigen (PSA) should be measured only if a diagnosis of prostate cancer will change the management or if PSA can assist in decision-making for patients at risk of symptom progression and complications. Renal function must be assessed if renal impairment is suspected from the history and clinical examination, if the patient has hydronephrosis, or when considering surgical treatment for male LUTS. Uroflowmetry should be performed before any treatment. Imaging of the upper urinary tract in men with LUTS should be performed in patients with large PVR, haematuria, or a history of urolithiasis. Imaging of the prostate should be performed if this assists in choosing the appropriate drug and when considering surgical treatment. Urethrocystoscopy should only be performed in men with LUTS to exclude suspected bladder or urethral pathology and/or before minimally invasive/surgical therapies if the findings may change treatment. Pressure-flow studies should be performed only in individual patients for specific indications before surgery or when evaluation of the pathophysiology underlying LUTS is warranted. CONCLUSIONS: These guidelines provide evidence-based practical guidance for assessment of non-neurogenic male LUTS. An extended version is available online (www.uroweb.org/guidelines). PATIENT SUMMARY: This article presents a short version of European Association of Urology guidelines for non-neurogenic male lower urinary tract symptoms (LUTS). The recommended tests should be able to distinguish between uncomplicated male LUTS and possible differential diagnoses and to evaluate baseline parameters for treatment. The guidelines also define the clinical profile of patients to provide the best evidence-based care. An algorithm was developed to guide physicians in using appropriate diagnostic tests.