A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany).

Background: CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW). Methods: Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.9% NaCl). The primary objectives were to expand the safety database of CVnCoV and assess antibody responses against SARS-CoV-2. Primary safety and reactogenicity outcomes included solicited adverse events (AEs) within 7 days after each dose and unsolicited AEs within 28 days after each dose, with safety follow-up for 13 months after first vaccination. Since HCWs became eligible to receive an authorised vaccine during enrolment and efficacy results from HERALD CVnCoV trial were made available on 30th of June 2021, this study was unblinded and converted to an open label design. Results: Most participants in the CVnCoV group reported at least one solicited AE, a relatively high number being Grade 3 (43.3% in CVnCoV group and 6.4% in placebo group). Most AEs were short in duration and did not affect vaccine compliance. The percentage of participants with unsolicited AEs up to 28 days after any dose was slightly higher in CVnCoV group (37.0%) compared with placebo group (31.2%). IgG binding antibodies against the receptor binding domain of the SARS-CoV-2 spike protein were observed after vaccination, with higher seroconversion rates and antibody levels after the second dose. Conclusion: No safety concerns for CVnCoV were identified up to 1 year post second dose. IgG responses against SARS-CoV-2 were observed after two doses, with a higher seroconversion rate and antibody levels observed after second vaccination.Study registration: ClinicalTrials.gov NCT04674189, study period: 23rd of December 2020 to 8th of June 2022.

Male fertility restoration: in vivo and in vitro stem cell-based strategies using cryopreserved testis tissue: a scoping review.

IMPORTANCE: Advances in the treatment of childhood cancer have significantly improved survival rates, with more than 80% of survivors reaching adulthood. However, gonadotoxic cancer treatments endanger future fertility, and prepubertal males have no option to preserve fertility by sperm cryopreservation. In addition, boys with cryptorchidism are at risk of compromised fertility in adulthood. OBJECTIVE: To investigate current evidence for male fertility restoration strategies, explore barriers to clinical implementation, and outline potential steps to overcome these barriers, a scoping review was conducted. This knowledge synthesis is particularly relevant for prepubertal male cancer survivors and boys with cryptorchidism. EVIDENCE REVIEW: The review was conducted after the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews criteria and previously published guidelines and examined studies using human testis tissue of prepubertal boys or healthy male adults. A literature search in PubMed was conducted, and 72 relevant studies were identified, including in vivo and in vitro approaches. FINDINGS: In vivo strategies, such as testis tissue engraftment and spermatogonial stem cell transplantation, hold promise for promoting cell survival and differentiation. Yet, complete spermatogenesis has not been achieved. In vitro approaches focus on the generation of male germ cells from direct germ cell maturation in various culture systems, alongside human induced pluripotent stem cells and embryonic stem cells. These approaches mark significant advancements in understanding and promoting spermatogenesis, but achieving fully functional spermatozoa in vitro remains a challenge. Barriers to clinical implementation include the risk of reintroducing malignant cells and introduction of epigenetic changes. CONCLUSION: Male fertility restoration is an area in rapid development. On the basis of the reviewed studies, the most promising and advanced strategy for restoring male fertility using cryopreserved testis tissue is direct testis tissue transplantation. RELEVANCE: This review identifies persistent barriers to the clinical implementation of male fertility restoration. However, direct transplantation of frozen-thawed testis tissue remains a promising strategy that is on the verge of clinical application.

Acute postoperative pain and catastrophizing in unicompartmental knee arthroplasty: a prospective, observational, single-center, cohort study.

BACKGROUND AND OBJECTIVES: Pain catastrophizing is associated with acute pain after total knee arthroplasty. However, the association between pain catastrophizing and acute pain after unicompartmental knee arthroplasty (UKA) remains unclear. METHODS: We investigated the incidence of predicted high-pain and low-pain responders, based on a preoperative Pain Catastrophizing Scale score >20 or ≤20, respectively, and the acute postoperative pain course in both groups. Patients undergoing UKA were consecutively included in this prospective observational cohort study. Pain at rest and during walking (5 m walk test) was evaluated preoperatively, at 24 hours postoperatively, and on days 2-7 using a pain diary. RESULTS: 125 patients were included, with 101 completing the pain diary. The incidence of predicted high-pain responders was 31% (95% CI 23% to 40%). The incidence of moderate to severe pain during walking at 24 hours postoperatively was 69% (95% CI 52% to 83%) in predicted high-pain responders and 66% (95% CI 55% to 76%) in predicted low-pain responders; OR 1.3 (95% CI 0.5 to 3.1). The incidence of moderate to severe pain at rest 24 hours postoperatively was 49% (95% CI 32% to 65%) in predicted high-pain responders and 28% (95% CI 19% to 39%) in predicted low-pain responders; OR 2.6 (95% CI 1.1 to 6.1; p=0.03). Pain catastrophizing was not associated with increased cumulated pain during walking on days 2-7. CONCLUSIONS: The incidence of predicted high-pain responders in UKA was slightly lower than reported in total knee arthroplasty. Additionally, preoperative pain catastrophizing was not associated with acute postoperative pain during walking.

Data Availability Statements and Data Sharing in Urology: A False Promise?

BACKGROUND AND OBJECTIVE: It is considered standard for authors of scientific papers to provide access to their raw data. The purpose of this study was to investigate data availability statements (DAS) and the actual availability of data in urology. METHODS: The DAS policies of the top ten urology journals were retrieved. Then 190 selected papers were classified according to their DAS status. Finally, we contacted the corresponding authors of papers that stated that data were available on request to enquire about this possibility. KEY FINDINGS AND LIMITATIONS: All journals either required or highly recommended a DAS. Among the selected articles, 52% (99/190) included a DAS stating data availability, most often on reasonable request to the corresponding author. A formal DAS was lacking in 29.5% (56/190) of the articles, with an additional 18.3% (35/190) citing various reasons for data unavailability. On contact, 23.4% (15/64) of corresponding authors indicated a willingness to share their data. Overall, data were unavailable in 73.7% (140/190) of cases. There was no difference between papers dealing with malignant and benign diseases. CONCLUSIONS AND CLINICAL IMPLICATIONS: There is a gap between the intention to share data and actual practice in major urological journals. As data sharing plays a critical role in safeguarding the reliability of published results and in the potential for reanalysis and merging of datasets, there is a clear need for improvement. Easier access to data repositories and stronger enforcement of existing journal policies are essential. PATIENT SUMMARY: To ensure the reliability of data and allow further analyses, major urology journals require authors to make their data available to other researchers when possible. However, in practice we found that data were only accessible for about a quarter of published scientific papers.

Platelet-rich plasma therapy in erectile dysfunction and Peyronie's disease: a systematic review of the literature.

PURPOSE: Platelet-rich plasma (PRP) as a regenerative therapy has gained interest in the field of andrology for the treatment of erectile dysfunction (ED) and Peyronie's disease (PD). This systematic review aims to critically evaluate the current evidence on the use of PRP for these conditions. METHODS: We performed a systematic literature search according to the PRISMA guidelines using PubMed and Scopus databases in December 2023. Studies were included if they evaluated the effect of PRP therapy for ED or PD in humans. RESULTS: We identified 164 articles, 17 of which were included, consisting of 11 studies on ED, 5 studies on PD, and 1 study on both. We included four randomized controlled trials, 11 prospective cohort studies, and three retrospective cohort studies including a total of 1099 patients. The studies on ED and PD generally showed small to moderate benefits with mild and transient side effects and no major adverse events were reported. General limitations included variations in PRP protocols, small sample sizes, short follow-up periods, and lack of control groups except in the three randomized trials on ED and the one on PD. CONCLUSION: The literature on PRP therapy in andrology is limited and difficult to interpret due to variations in protocols and methodological drawbacks. Further research is necessary to determine the optimal preparation and treatment protocols for PRP therapy and clarify its effectiveness in andrology.

Implementation of outpatient hip and knee arthroplasty in a multicenter public healthcare setting.

BACKGROUND AND PURPOSE: Length of hospital stay after hip and knee arthroplasty is about 1 day in Denmark with few patients discharged on the day of surgery. Hence, a protocol for multicenter implementation of discharge on day of surgery has been instituted. We aimed to describe the implementation of outpatient hip and knee arthroplasty in a multicenter public healthcare setting. METHODS: We performed a prospective multicenter study from 7 public hospitals across Denmark. Patients were screened using well-defined in- and exclusion criteria and were discharged on day of surgery when fulfilling functional discharge criteria. The study period was from September 2022 to February 2023 with variable start of implementation. Data from the same centers in a 6-month period before the COVID pandemic from July 2019 to December 2019 was used for baseline control. RESULTS: Of 2,756 primary hip and knee arthroplasties, 37% (95% confidence interval [CI] 35-39) were eligible (range 21-50% in centers) and 52% (range 24-62%) of these were discharged on day of surgery. 21% (CI 20-23) of all patients (eligible and non-eligible) were discharged on day of surgery with a range of 10-31% within centers. This was an additional 15% (CI 13-17, P < 0.001) compared with patients discharged in the control period (6% in 2019). CONCLUSION: We found it possible to perform outpatient hip and knee replacement in 21% of patients in a public healthcare setting, probably to be increased with further center experience.

Electrocardiographic markers in patients with type 2 diabetes and the role of diabetes duration.

BACKGROUND: The association between type 2 diabetes and electrocardiographic (ECG) markers are incompletely explored and the dependence on diabetes duration is largely unknown. We aimed to investigate the electrocardiographic (ECG) changes associated with type 2 diabetes over time. METHODS: In this cross-sectional study, we matched people with type 2 diabetes 1:1 on sex, age, and body mass index with people without diabetes from the general population. We regressed ECG markers with the presence of diabetes and the duration of clinical diabetes, respectively, adjusted for sex, age, body mass index, smoking, heart rate, diabetes medication, renal function, hypertension, and myocardial infarction. RESULTS: We matched 988 people with type 2 diabetes (332, 34% females) with as many controls. Heart rate was 8 bpm higher (p < 0.001) in people with vs. without type 2 diabetes, but the difference declined with increasing diabetes duration. For most depolarization markers, the difference between people with and without type 2 diabetes increased progressively with diabetes duration. On average, R-wave amplitude was 6 mm lower in lead V5 (p < 0.001), P-wave duration was 5 ms shorter (p < 0.001) and QRS duration was 3 ms (p = 0.03). Among repolarization markers, T-wave amplitude (measured in V5) was lower in patients with type 2 diabetes (1 mm lower, p < 0.001) and the QRS-T angle was 10 degrees wider (p = 0.002). We observed no association between diabetes duration and repolarization markers. CONCLUSIONS: Type 2 diabetes was independently associated with electrocardiographic depolarization and repolarization changes. Differences in depolarization markers, but not repolarization markers, increased with increasing diabetes duration.

Patients' Experiences With Digitalization in the Health Care System: Qualitative Interview Study.

BACKGROUND: The digitalization of public and health sectors worldwide is fundamentally changing health systems. With the implementation of digital health services in health institutions, a focus on digital health literacy and the use of digital health services have become more evident. In Denmark, public institutions use digital tools for different purposes, aiming to create a universal public digital sector for everyone. However, this digitalization risks reducing equity in health and further marginalizing citizens who are disadvantaged. Therefore, more knowledge is needed regarding patients' digital practices and experiences with digital health services. OBJECTIVE: This study aims to examine digital practices and experiences with public digital health services and digital tools from the perspective of patients in the neurology field and address the following research questions: (1) How do patients use digital services and digital tools? (2) How do they experience them? METHODS: We used a qualitative design with a hermeneutic approach. We conducted 31 semistructured interviews with patients who were hospitalized or formerly hospitalized at the department of neurology in a hospital in Denmark. The interviews were audio recorded and subsequently transcribed. The text from each transcribed interview was analyzed using manifest content analysis. RESULTS: The analysis provided insights into 4 different categories regarding digital practices and experiences of using digital tools and services in health care systems: social resources as a digital lifeline, possessing the necessary capabilities, big feelings as facilitators or barriers, and life without digital tools. Our findings show that digital tools were experienced differently, and specific conditions were important for the possibility of engaging in digital practices, including having access to social resources; possessing physical, cognitive, and communicative capabilities; and feeling motivated, secure, and comfortable. These prerequisites were necessary for participants to have positive experiences using digital tools in the health care system. Those who did not have these prerequisites experienced challenges and, in some cases, felt left out. CONCLUSIONS: Experiences with digital practices and digital health services are complex and multifaceted. Engagement in digital practices for the examined population requires access to continuous assistance from their social network. If patients do not meet requirements, digital health services can be experienced as exclusionary and a source of concern. Physical, cognitive, and communicative difficulties might make it impossible to use digital tools or create more challenges. To ensure that digitalization does not create inequities in health, it is necessary for developers and institutions to be aware of the differences in digital health literacy, focus on simplifying communication with patients and next of kin, and find flexible solutions for citizens who are disadvantaged.

Champions in usage of medial unicompartmental knee arthroplasty : The story behind the Danish success.

Historically, the use of medial unicompartmental knee arthroplasty (mUKA) as treatment for end-stage anteromedial osteoarthritis (AMOA) of the knee was limited by contraindications due to age, weight, and activity level; however, now evidence-based, validated, and less selective criteria are used rendering nearly 50% of end-stage OA patients eligible for mUKA. Recent studies have showcased benefits, such as shorter hospital stays, cost efficiency, and comparable functional outcomes to total knee arthroplasty (TKA). Notably, revision rates have been shown to markedly decrease with increased usage, with an ideal usage of > 30% but an acceptable usage of 20-60%. The usage of unicompartmental knee arthroplasty (UKA) varies among countries, with Denmark achieving a notably higher usage compared to Sweden, the UK, the Netherlands, the USA and Germany. This article investigates potential factors contributing to Denmark having a higher national usage of mUKA, surpassing the recommended threshold of a usage > 20%. We explore the tradition for national alliances and streamlined surgical education as possible explanations of this development. These insights offer valuable perspectives for potentially optimizing surgical approaches and implant choices in the surgical treatment of end-stage AMOA of the knee across diverse healthcare settings, underscoring the impact of collective strategies in advancing knee arthroplasty practices, ultimately benefiting patients.

Percutaneous Image-Guided Cryoablation of Endophytic Renal Cell Carcinoma.

PURPOSE: Endophytic renal cancer treatment is a challenge. Due to difficulties in endophytic tumor visualization during surgical extirpation, image-guided percutaneous cryoablation (PCA) is an attractive alternative. The minimally invasive nature of PCA makes it favorable for comorbid patients as well as patients in which surgery is contraindicated. Oncological outcomes and complications after PCA of endophytic biopsy-proven renal cell carcinoma (RCC) were reviewed in this study. MATERIALS AND METHODS: Patients were included after a multidisciplinary team conference from January 2015 to November 2021. Inclusion criteria were endophytic biopsy-proven T1 RCC treated with PCA with one year of follow-up. Complications were reported according to the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) classification system and the Clavien-Dindo classification (CDC) system. Major complications were defined as a grade ≥ 3 according to the CDC. RESULTS: Fifty-six patients were included with a total of 56 endophytic tumors treated during 61 PCA sessions. The median RENAL nephrometry score was 9 (IQR 2), and the mean tumor size was 25.7 mm (SD ± 8.9 mm). Mean hospitalization time was 0.39 (SD ± 1.1) days. At a mean follow-up of 996 days (SD ± 559), 86% of tumors were recurrence free after one PCA. No patients progressed to metastatic disease. According to the CIRSE classification, 10.7% (n = 6) had grade 3 complications, and 5.4% (n = 3) had CDC major complications. CONCLUSION: This study demonstrates that PCA of endophytic biopsy-proven T1 RCC is safe with few major complications and excellent local tumor control rates at almost three-year mean follow-up. LEVEL OF EVIDENCE 3: Retrospective cohort study.

Characterizing a standardized BioPart for BAG-specific expression in C. elegans.

Biological parts (BioParts) are modular and standardized DNA sequences that encode biological functions and contribute to the efficient biological engineering of complex systems. Here, we characterize a short BioPart (P flp-17 , 300 bp) for bright multicopy and single-copy BAG-specific expression starting from the gastrula stage in hermaphrodite and male C. elegans . We have generated standardized P flp-17 cloning vectors for BAG-specific gfp and mScarlet expression compatible with extra-chromosomal arrays and for single-copy transgene insertion. The short P flp-17 promoter is easy to generate by gene synthesis and has been incorporated into our online transgene design tool (www.wormbuilder.org/transgenebuilder ) .

Patient attitudes towards day-case hip and knee arthroplasty.

Aims: This study aimed to investigate patients' attitudes towards day-case hip and knee arthroplasty and to describe patient characteristics associated with different attitudes, with the purpose of providing an insight into the information requirements for patients that surgeons should address when informing patients about day-case surgery. Methods: A total of 5,322 patients scheduled for hip or knee arthroplasty between 2016 and 2022 were included in the study. Preoperatively, patients were asked if they were interested in day-case surgery ('Yes', 'Do not know', 'No'). Patient demographics including age, BMI, sex, and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) were examined within each attitude group. Additionally, changes in attitude were assessed among patients who had completed the questionnaire in association with prior hip or knee arthroplasty. Results: Of the surveyed patients, 41.8% were interested in day-case surgery (n = 2,222), 20.8% responded 'Do not know' (n = 1,105), and 37.5% were not interested (n = 1,995). Patients who were not interested had a higher mean age ('No', 70.2 years (SD 10.0) vs 'Yes', 65.2 years (SD 10.7)), with a majority being female ('No', 71.9% female (n = 1,434) vs 'Yes', 48.6% female (n = 1,081)). Approximately 20% of patients responded 'Do not know' regardless of age, sex, and PROMs. Patients reporting anxiety/depression based on EQ-5D-3L more frequently answered 'No' (56.9%; 66/116) compared to those not experiencing anxiety/depression (34.9%; 1,356/3,890). Among patients who responded 'Do not know' before their first surgery, over 70% changed their attitude to either 'Yes' (29.9%; 38/127) or 'No' (40.9%; 52/127) at their subsequent surgery. Conclusion: From 2016 to 2022, 58.3% of hip and knee arthroplasty patients expressed uncertainty or no interest in day-case surgery. In connection with current initiatives to increase the number of day-case arthroplasty procedures, there should be a focus on informing patients to address the prevalent negative or uncertain attitude. Further research is needed to investigate what preoperative information patients consider crucial in their decision-making process regarding day-case surgery.

Can nerve monitoring during radical prostatectomy improve functional outcomes? A randomised trial.

OBJECTIVE: To explore how the use of the ProPep® Nerve Monitoring System (ProPep Surgical, Austin, TX, USA) for intraoperative specific sparing of the pudendal nerve fibres influences postoperative functional outcomes after unilateral nerve-sparing (UNS) or non-nerve-sparing (NNS) robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: We randomised 100 men undergoing UNS or NNS RARP to ProPep nerve monitoring during RARP (intervention) or standard of care RARP (control). Functional outcomes were assessed at 3, 6, and 12 months using the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), the International Prostate Symptom Score, the Danish Prostate Symptom Score, the International Index of Erectile Function, the Erection Hardness Scale, and 24-h pad tests. The primary outcome was the difference in ICIQ-SF score between the groups at 12 months. Secondary outcomes included differences in the remaining outcome measures and continence rates at all time points. Continence was defined as the use of no pads and the answer 'Never' to the question: 'How often do you experience urinary incontinence?' or a urine loss of <8 g on the 24-h pad test. RESULTS: A total of 82 patients were included in the per-protocol analysis at 12 months with 41 in each group. At 12 months the mean ICIQ-SF scores were 5.37 (95% confidence interval [CI] 3.71-7.03) and 5.66 (95% CI 4.05-7.27) for the intervention and control groups, respectively (P = 0.8). There were no statistically significant differences in any of the remaining outcomes. However, the continence rate was higher in the intervention group at 6 months (63% vs 44%, P = 0.09). CONCLUSIONS: Intraoperative nerve monitoring did not result in better functional outcomes following UNS or NNS RARP. Larger studies are needed to explore if ProPep can reduce the time to continence after RARP.

Half of all hip and knee arthroplasty patients may be potential day-case candidates: a nationwide register study of 166,730 procedures.

BACKGROUND AND PURPOSE: The overall potential pool of day-case candidates on a national level in hip and knee arthroplasty is unknown. We aimed to estimate the proportion of hip and knee arthroplasty patients eligible for day-case surgery based on contemporary widely used criteria and determine whether there has been a change in the proportion of eligible patients over time and, secondarily, to investigate the proportion of eligible patients discharged on the day of surgery. METHODS: Based on data from the Danish National Patient Register, we identified all patients undergoing primary unilateral hip or knee arthroplasty from January 2010 to March 2020. Using a modification of day-case eligibility criteria proposed by a national multicenter collaboration, we sorted patients into either day-case eligible or ineligible. A day-case procedure was defined as discharge on the day of surgery. RESULTS: We included patients comprising a total of 166,730 primary total hip (THA), total knee (TKA), and unicompartmental knee arthroplasty (UKA). 48% (95% confidence interval [CI] 48-49) were eligible for day-case surgery, with a decline from 50% (CI 49-51) in 2010 to 46% (CI 46-47) eligible in 2019. More UKA patients were day-case eligible (55%, CI 54-56) than THA (47%, CI 47-48) and TKA patients (49%, CI 48-49). A maximum of 8.0% (CI 7.4-8.5) of eligible patients were discharged on the day of surgery in 2019. CONCLUSION: 48% of the Danish hip and knee arthroplasty patients were potential day-case candidates, with a small decline in eligibility from 50% in 2010 to 46% in 2019. Day of surgery discharge among day-case eligible patients peaked at 8% in 2019. Thus, the potential for more day-case surgery seems large.

Gonorrhoea on the rise in Denmark since 2022: distinct clones drive increase in heterosexual individuals.

A surge in gonorrhoea in Denmark has occurred since 2022, a 46% increase from 2021. National surveillance, leveraging mandatory reporting and epidemiological data, highlights three distinct clades linked to heterosexual transmission. Despite the rise, these exhibit high susceptibility, contrasting MSM-associated strains. Geographical hotspots and age-specific patterns further illuminate transmission dynamics. The combination of genomic and epidemiological data provides novel insights into the evolving landscape of gonorrhoea, indicating potential shifts in infection dynamics and transmissibility.

Testicular biopsies in men with testicular microlithiasis and additional risk factors for cancer: A case series.

BACKGROUND: Testicular microlithiasis is the presence of small calcifications in the testicular parenchyma. The association between testicular microlithiasis and germ cell neoplasia in situ, a precursor to testicular cancer, is still unclear. OBJECTIVES: To determine the incidence of germ cell neoplasia in situ in men with testicular microlithiasis and evaluate the indication for testicular biopsy according to risk factors in the form of male infertility/reduced semen quality, testicular atrophy, and history of cryptorchidism. MATERIALS AND METHODS: This retrospective case series included all patients diagnosed with testicular microlithiasis who underwent testicular biopsies at three hospitals in Denmark between 2007 and 2021. The medical records of 167 patients were reviewed, and data on patient demographics, testicular microlithiasis characteristics, risk factors, histological findings, and treatments were collected. The main outcome measure was the incidence of germ cell neoplasia in situ in relation to each risk factor. The data were analyzed using descriptive statistics. Logistic regression was used to examine the odds ratio of germ cell neoplasia in situ in patients with testicular microlithiasis and testicular atrophy. RESULTS: Germ cell neoplasia in situ was found in 13 out of 167 patients (7.8% [95% confidence interval: 4.3, 13.2]). Eleven of these had testicular atrophy resulting in a significantly higher incidence in this group than other risk factors (odds ratio 9.36 [95% confidence interval: 2.41, 61.88]; p = 0.004). DISCUSSION: The study comprises the largest cohort to date of men who have undergone testicular biopsies because of testicular microlithiasis and additional risk factors. Limitations include its retrospective design, and relatively low absolute numbers of patients with germ cell neoplasia in situ on biopsies. CONCLUSION: This study found that men with testicular microlithiasis and testicular atrophy are at an increased risk of germ cell neoplasia in situ. Additionally, our results indicate that biopsies should be considered in men with a combination of subfertility and bilateral testicular microlithiasis. Our findings do not support testicular biopsies for men with testicular microlithiasis and other risk factors.

A prospective cohort study of SARS-CoV-2 infection-induced seroconversion and disease incidence in German healthcare workers before and during the rollout of COVID-19 vaccines.

We assessed the seroepidemiology of SARS-CoV-2 infection and the incidence of coronavirus disease 2019 (COVID-19) before and during the rollout of COVID-19 vaccines, in a prospective observational cohort study on healthcare workers (HCWs) in a large tertiary hospital in Mainz, Germany. Antibody status was assessed during six visits between September 2020 and February 2022. Self-reported symptoms were collected using a smartphone application; symptomatic HCWs were tested using real-time polymerase chain reaction (RT-PCR) assays for SARS-CoV-2. Rates of virologically confirmed and severe COVID-19 were estimated using the U.S. Food and Drug Administration (FDA) and Coalition for Epidemic Preparedness Innovations (CEPI) case definitions, respectively, and were contrasted to background community transmission and circulating SARS-CoV-2 variants. A total of 3665 HCWs were enrolled (mean follow-up time: 18 months); 97 met the FDA definition of virologically confirmed COVID-19 (incidence rate (IR) 2.3/1000 person-months (PMs), one severe case). Most cases reported ≥2 symptoms, commonly, cough and anosmia or ageusia. Overall, 263 individuals seroconverted (IR 6.6/1000 PMs-2.9 times the estimated IR of COVID-19), indicating many cases were missed, either due to asymptomatic infections or to an atypical presentation of symptoms. A triphasic trend in anti-SARS-CoV-2 seroprevalence and seroconversion was observed, with an initial increase following the rollout of COVID-19 vaccines, a two-fold decline six months later, and finally a six-fold increase by the end of the study when Omicron was the dominant circulating variant. Despite the increase in infection rates at the end of the study due to the circulation of the Omicron variant, the infection and disease rates observed were lower than the published estimates in HCWs and rates in the general local population. Preferential vaccination of HCWs and the strict monitoring program for SARS-CoV-2 infection are the most likely reasons for the successful control of COVID-19 in this high-risk population.

Phosphodiesterase type 5 inhibitors do not prevent curvature progression but shorten pain duration in the active phase of Peyronie's Disease: A retrospective cohort study.

Treatment with Phosphodiesterase Type 5 inhibitors (PDE5is) has shown promise in managing Peyronie's disease (PD) during its active phase. In a retrospective cohort study of 133 PD patients, we compared daily PDE5i treatment (sildenafil 25 mg or tadalafil 5 mg) in Group 1 (n = 101) to no treatment in Group 2 (n = 32). The mean age ± SD was 58.5 ± 10, (range: 29-77) years in Group 1 and 59 ± 13.7 years (range: 23-80) in Group 2 (p = 0.5). Mean symptom onset-to-visit time was 10.6 ± 7.2 months (range: 1-37) in Group 1 and 11 ± 6.3 months (range 3-27) in Group 2 (p = 0.5). Mean penile curvature change was +0.87° (95% CI: -1.8, 3.5) in Group 1 and +5.72° (95% CI: 1.4, 10) in Group 2 (p = 0.07) between first and last observations. Group 1 experienced shorter mean pain duration (9.1 ± 4.7 months, range: 2.5-24) than Group 2 (12.2 ± 6.5 months, range: 5-28) (p = 0.04). When controlling for baseline curvature and symptom onset-to-visit time, there were no differences between groups (-4.7, 95% CI: -10, 0.6) (p = 0.08). In conclusion, continuous PDE5i treatment did not affect PD curvature progression but showed a promising effect on pain.