bluuebunny/crossref_metadata_2025 huggingface dataset:
Compatibility of emerging AI regulation with GATS and TBT: the EU Artificial Intelligence Act
Authors: Soprana Marta
Published: December 2024

Governments have recently started to design policies that are specific to artificial intelligence (AI), which is projected to become the dominant technology in the decades to come. AI is increasingly permeating all aspects of the digital economy, including trade in goods and services, giving rise to concerns whether emerging AI-specific regulation may run afoul of international economic law (IEL). However, studies on the law of the World Trade Organization have yet to pay close attention to the European Union (EU) Artificial Intelligence Act (AI Act), the first binding regulation of its kind in the world. This paper seeks to address this gap in the literature. It examines the compatibility of emerging AI regulation with multilateral trade rules, using the EU AI Act as a case study. More specifically, it analyses to what extent the EU AI Act’s disciplines on prohibited AI systems are likely to violate the EU’s existing obligations and commitments enshrined in the Agreement on Technical Barriers to Trade and the General Agreement on Trade in Services. This paper demonstrates that there is potential for conflict between the EU regulation and these two multilateral trade agreements. It also suggests that, although emerging AI regulation can represent a challenge for the future of IEL, the latter can play a role in guiding and shaping AI-specific regulation moving forward.
Data ownership in genomic research consortia
Authors: Nielsen Jane , Nicol Dianne
Published: December 2024

Discourse around ownership of genomic sequence data has proliferated over recent years. There are likely to be few people who don’t feel a degree of connectedness to their genomic data. The inclusion of individuals’ genomic data in genomic datasets is critical to genomic research, and these datasets are most effective if shared widely. Genomic research consortia are an integral part of the genomic data sharing ecosystem, critical in facilitating data sharing among research groups. This article considers the property status of genomic data at various stages of the research life cycle, and the potential ‘ownership’ claims that may be made by various actors in data sharing networks. It does so by comparing the legal position with the findings of a study that examined policy documents and guidelines produced by international research consortia. This analysis enabled us to assess whether consideration of property interests is at the forefront of data sharing efforts, and if so, where such property interests are likely to reside.
Comorbidities in early-onset sporadic versus presenilin-1 mutation-associated Alzheimer disease dementia: Evidence for dependency on Alzheimer disease neuropathological changes
Authors: Sepulveda-Falla Diego , Villegas Lanau Carlos Andrés , White III Charles , Serrano Geidy E , Acosta-Uribe Juliana , Mejía-Cupajita Barbara , Villalba-Moreno Nelson David , Lu Pinzhang , Glatzel Markus , Kofler Julia K , Ghetti Bernardino , Frosch Matthew P , Restrepo Francisco Lopera , Kosik Kenneth S , Beach Thomas G
Published: December 2024

Studying comorbidities in early onset Alzheimer disease (AD) may provide an advantageous perspective on their pathogenesis because aging factors may be largely inoperative for these subjects. We compared AD comorbidities between early-onset sporadic cases and American and Colombian cases with PSEN1 mutations. AD neuropathological changes (ADNC) were very severe in all groups but more severe in the PSEN1 groups. Lewy body disease and cerebral white matter rarefaction were the most common (up to 60%) of AD comorbidities, followed by arteriolosclerosis (up to 37%), and large-vessel atherosclerosis (up to 20%). Differences between the 3 groups included earlier age of onset in the American PSEN1 cases, shorter disease duration in sporadic cases, and more frequent large-vessel atherosclerosis and cerebral amyloid angiopathy in the Colombian PSEN1 cases. Logistic regression models adjusted for age and sex found the presence of a PSEN1 mutation, an apolipoprotein ε4 allele and TDP-43 pathology to predict an earlier age of onset; Hispanic ethnicity and multiracial subjects were predictive of severe CAA. Comorbidities are common in early onset AD and should be considered when planning clinical trials with such subjects. However, they may be at least partially dependent on ADNC and thus potentially addressable by anti-amyloid or and/anti-tau therapies.
An analysis of RNA quality metrics in human brain tissue
Authors: Tian Jiahe , Lam Tiffany G , Ross Sophie K , Ciener Benjamin , Leskinen Sandra , Sivakumar Sharanya , Bennett David A , Menon Vilas , McKhann Guy M , Runnels Alexi , Teich Andrew F
Published: December 2024

Human brain tissue studies have used a range of metrics to assess RNA quality but there are few large-scale cross-comparisons of presequencing quality metrics with RNA-seq quality. We analyzed how postmortem interval (PMI) and RNA integrity number (RIN) before RNA-seq relate to RNA quality after sequencing (percent of counts in top 10 genes [PTT], 5′ bias, and 3′ bias), and with individual gene counts across the transcriptome. We analyzed 4 human cerebrocortical tissue sets (1 surgical, 3 autopsy), sequenced with varying protocols. Postmortem interval and RIN had a low inverse correlation (down to r = −0.258, P < .001 across the autopsy cohorts); both PMI and RIN showed consistent and opposing correlations with PTT (up to r = 0.215, P < .001 for PMI and down to r = −0.677, P < .001 for RIN across the autopsy cohorts). Unlike PMI, RIN showed consistent correlations with measurements of 3′ and 5′ bias in autopsies (r = −0.366, P < .001 with 3′ bias). RNA integrity number correlated with 3933 genes across the 4 datasets vs 138 genes for PMI. Neuronal and immune response genes correlated positively and negatively with RIN, respectively. Thus, different gene sets have divergent relationships with RIN. These analyses suggest that conventional metrics of RNA quality have varying values and that PMI has an overall modest effect on RNA quality.
Neurological Disorders and Use of Healthcare Services After Enteroviral Meningitis in Childhood: A Nationwide, Population-Based Cohort Study
Authors: Graham Emma E , Tetens Malte M , Bodilsen Jacob , Andersen Nanna S , Dessau Ram , Ellermann-Eriksen Svend , Franck Kristina , Midgley Sofie , Møller Jens Kjølseth , Nielsen Alex Christian , Nielsen Lene , Søgaard Kirstine K , Østergaard Christian , Lebech Anne-Mette , Nygaard Ulrikka , Omland Lars H , Obel Niels
Published: December 2024

Background

Nervous system infections are associated with long-term risks of neurological disorders and healthcare service utilization, but little data exist on the long-term risks of enteroviral meningitis in childhood.

Methods

We performed a population-based, nationwide registry-based matched cohort study (1997-2021). We included 925 children with enteroviral meningitis aged <17 years, a comparison cohort, and a cohort of siblings of all individuals. To illustrate short- and long-term risks of neurological disorders, we calculated 1-year cumulative incidences and age- and sex-adjusted hazard ratios (aHRs) with 95% confidence intervals (95% CIs) during years 1-20 of follow-up. We further calculated the annual proportion of individuals using antiepileptic medication and healthcare services.

Results

Young infants (0 to <90 days) and older children (≥90 days to <17 years) had slightly increased short- and long-term risks of neurological disorders after enteroviral meningitis compared to comparison cohort members (1-year cumulative incidence: 1.4% vs 0.6%, and 1.5% vs 0.4%, 1-20-year adjusted hazard ratio: 2.0 [95% CI: 1.2-3.2] and 1.7 [95% CI: 1.0-2.8]). Older children had increased use of antiepileptic medication, as well as the use of health care services both before and after enteroviral meningitis, with a similar trend among their siblings.

Conclusions

Enteroviral meningitis in childhood appears to be associated with increased risk of short- and long-term neurological morbidity, though our estimates in older children may be confounded by prior neurological morbidity or increased healthcare-seeking behavior. Our findings suggest a generally good prognosis after enteroviral meningitis, though clinicians should be aware of the risk of neurological disorders in selected patients.
(014) THE EVOLUTION OF PATIENT SATISFACTION AND WELL- BEING OVER TIME FOLLOWING INFLATABLE PENILE PROSTHESIS
Authors: Pinkhasov A , Guillen A , Bonakdarhashemi M , Helo S , Ziegelmann M , Kohler T
Published: December 2024

Introduction

Penile prosthesis (PP) implantation is associated with high patient satisfaction in patients with medically refractory erectile dysfunction (ED). There remains a paucity in the literature regarding the temporal evolution of patient satisfaction and well-being following PP surgery.

Objective

We aimed to identify factors responsible for patient satisfaction after surgery.

Methods

We initiated a registry of patients undergoing surgery for placement of a PP. After consent, perioperative study assessments and follow-ups were conducted. After surgery, patients were directed to a survey at 6 months and 12 months. Patients who completed both items were included in the analysis.

Results

A total of 304 patients had a PP placement, of these 101 completed the initial surveys. Overall patient satisfaction was favorable and durable and 6- and 12-months (87% and 82% respectively, p = 0.11). Confidence with device use was reported by 92% at 6 months, without significant change at 1 year (vs. 95%, p = 0.91). At 6 months, 81% of patients reported that their PP met or exceeded expectations, 83% of patients reported that they would undergo the procedure again, and 80% would recommend to a friend/family member. [Figure 1] At 6 months, 78 patients (77%) reported a moderate to high improvement in their overall sense of well-being related to their PP. This percentage further increased to 91% at 12-months (p < 0.001). Additionally, 36% of patients reported that they had made significant improvements to their overall lifestyle since receiving the PP, and this increased to 48% by 12 months post-operatively (p = 0.082).

Conclusions

Penile prosthesis satisfaction is evident and durable as early as 6 months following surgery. Factors such as perceived overall well-being continued to significantly improve past 6 months, and nearly half of patients reported overall lifestyle improvement following surgery.

Disclosure

Yes, this is sponsored by industry/sponsor: Coloplast.

Clarification: Industry funding only - investigator initiated and executed study.
(058) DOES TREATING OBSTRUCTIVE SLEEP APNEA HELP WITH STUTTERING PRIAPISM? A CASE STUDY
Authors: Tabei SS , Alvey L , Baas W
Published: December 2024

Introduction

Patients with sickle cell anemia are prone to developing stuttering priapism. Contributing factors include red blood cell deformation, vascular occlusion, nitric oxide dysregulation, endothelial dysfunction, and hypoxia. Some studies have indicated that oxyhemoglobin desaturation occurs at a higher rate during sleep and may lead to priapism episodes in patients with an underlying risk factor.

Objective

To assess the role of continuous positive airway pressure (CPAP) and improvement in obstructive sleep apnea symptoms in reducing night-time priapism episodes in a patient with sickle cell anemia.

Methods

A 43-year-old man who was a known case of sickle cell anemia presented to us with a 3-year history of recurrent episodes of stuttering priapism. Interestingly, these episodes occurred exclusively at night during his sleep which caused major disruption to the normal sleep pattern. The patient was initially commenced on hydroxyurea and pseudoephedrine which did not result in definitive improvement. Additional therapy such as adding terbutaline or increasing the dosage of hydroxyurea dosage by his hematology team was also inconclusive in reducing the burden of priapism. Other treatment options such as daily tadalafil was also trialed in this patient but did not show any improvement. At this stage, we decided to start the patient on bicalutamide which resulted in partial resolution of symptoms. A thorough review of the patient’s history revealed that he was a loud snorer and had not sought any treatment for this condition. We referred the patient for sleep evaluation and determined that he was suffering from concurrent obstructive sleep apnea. The patient was started on CPAP therapy and short-term follow-up at 3 months showed a resolution of priapism episodes following the addition of this treatment modality.

Results

Despite positive findings in our case, it cannot be fully determined whether or not the CPAP therapy was a definitive solution to relieving the priapism episodes. This improvement however warrants a closer look at the concurrent occurrence of obstructive sleep apnea and stuttering priapism in the setting of sickle cell anemia. Healthcare providers may inform sickle cell anemia patients regarding established obstructive sleep apnea screening protocols such as the STOP-BANG questionnaire.

Conclusions

The role of obstructive sleep apnea in the setting of sickle cell anemia-induced priapism is rather understudied. Further long-term trials are required to determine the definitive role of CPAP therapy in the setting of sickle cell anemia-induced stuttering priapism and obstructive sleep apnea.

Disclosure

No.
(062) THE RISK OF BIOCHEMICAL RECURRENCE OF PROSTATE CANCER IN MEN RECEIVING TESTOSTERONE REPLACEMENT THERAPY FOLLOWING RADICAL PROSTATECTOMY
Authors: Rust JO , Pereira TA , Smith R , Boris R , Egemba C , Green J , Koch M , Laniak L , Bahler C , Beneth Iv R , Spio M , Bernie HL
Published: December 2024

Introduction

Modern evidence and new theoretical frameworks have significantly challenged long-held beliefs about androgens and Prostate Cancer (PCa). However, there remain substantial controversies, especially concerning the use of testosterone therapy (TTh) in men with any history of PCa.

Objective

Analyze the risk of biochemical recurrence (BCR) of PCa in men who received TTh compared to men who did not receive TTh following radical RP.

Methods

Patients who underwent an RP from 2013-2023 with total testosterone (TT) and PSA levels were included. The risk groups were defined as the following: PSA <10 and grade group 1 (Gleason 6) as Low Risk; PSA is between 10 and 20, or grade group 2 or 3 (Gleason 7) as Intermediate Risk; PSA >20, or grade group 4 or 5 (Gleason 8 to 10), including T3b or T4 pathology as High Risk. BCR is defined as PSA > 0.2. Low testosterone (T) was described as a total T (TT) level < 300 ng/dL on two occasions using LCMS collected before noon. Men were grouped based on risk groups, and T levels and TTh use were recorded. Men were divided into TT >300 and no TTh (NT); TT <300, who did not receive TTh (LT-); TT <300, who received TTh (LT+); TT >300, who received TTh (NT+). Rates and time to BCR were recorded. Chi-square analysis and Fisher’s Exact test were performed for group comparisons. Kruskal Wallis Test was used to compare medians with log-rank (mantel-cox) significance reported. Kaplan Meier survival analysis was performed for time to BCR and time to follow-up. For all statistical analyses, clinical significance was assessed at p < 0.05. Individuals with missing values were not included in the analyses. All statistical analysis was conducted using SPSS.

Results

1105 men, with a median age of 63, were included. 1.6% had low risk (LR), 41.6% intermediate risk (IR), and 56.8% had high risk (HR) PCa. The median follow-up time was 50 months, and the median to BCR was ten months. 42% of patients were NT, 50.7% LT-, 3.4% LT+, and 3.9% were NT+. There was a significant difference in BCR rates between NT, LT-, LT+, and NT+ within the intermediate and high-risk groups (p < 0.001), with the HR PCa group having the highest BCR rate (46.9%). Within the HR PCa men, the LT- group had the highest BCR rate (61.5%) compared to the HR NT+, which had the lowest BCR at 20%. Lastly, LT- group had the lowest median time to recurrence (4 months) compared to LT+ which had the longest (51 months). (p = 0.020). (Figure 1).

Conclusions

TTh in men with PC does not increase rates of or time to BCR.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast; Boston Scientific; BK Ultrasound.
(071) NON-PROPRIETARY SUBCUTANEOUS TESTOSTERONE REPLACEMENT THERAPY FOR HYPOGONADAL MEN
Authors: Mossack S , Spellman A , Desouky E , Nabulsi O , Loos D , Levine L
Published: December 2024

Introduction

Advancement in the treatment for male hypogonadism involves investigation into safer, less expensive, and more effective alternatives than currently available treatment modalities, with subcutaneous testosterone replacement therapy (SubQ TRT) offering an attractive solution to several patient concerns.

Objective

To assess the use of non-proprietary SubQ TRT as treatment for hypogonadal men and its effect on HCT, PSA, and patient satisfaction.

Methods

This is a retrospective chart review of 93 men, mean age 60.6 years, receiving SubQ TRT with a mean follow up length of 17.9 months (range 0-52 months). Patient data was collected prior to initiation of therapy and at subsequent visits. Serum testosterone, HCT, and PSA were determined through regular blood draws, and patient demographics, AUA Symptom Index (AUA SI), Sexual Health Inventory for Men (SHIM) Scores, and patient satisfaction were collected at patient visits or via patient communication through email and phone. Univariate analysis and paired t-tests were used to analyze study variables.

Results

93 patients received SubQ TRT. Mean changes in total testosterone level (increased 125.77 ng/dL, p-value<0.001), hematocrit (increased 1.2%), PSA (increased 0.3 ng/dl), SHIM score (increased 0.9 points) and AUA symptom score (decreased 0.3 points) were calculated at the patients’ initial and follow up visits while on SubQ TRT. Sixty-eight (73%) patients had been on various combinations of TRT before switching to SubQ: IM, CC, Testopel, T-Gel, HCG, and Anastrozole. Patient satisfaction surveys were completed by 57 patients (61%), with 26 (78.9%) patients reporting satisfaction with SubQ TRT versus 28.1% with past forms of TRT. Patients reported SubQ TRT to be both easier (71.4%) and generally preferred (71.1%) over their previous form of TRT. Several patients stopped SubQ TRT including one patient with stroke. Lastly, a cost analysis using the average available GoodRx prices in the Chicagoland area showed that a 1-month supply of non-proprietary testosterone cypionate was $235.45 less than Xyosted (the only FDA-approved SubQ TRT for management of male hypogonadism).

Conclusions

Use of non-proprietary testosterone cypionate as TRT results in an elevation in serum testosterone with favorable side effect profiles and overall patient satisfaction.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant to Absorption Pharmaceuticals, Boston Scientific, Hybrid Medical, International Medical Devices and Irrimax Corp.
(076) THE MOBYUS CONSORTIUM: DEMOCRATIC, DECENTRALIZED, DYNAMIC MALE INFERTILITY RESEARCH
Authors: Naelitz B , Bushweller L , Nam C , Nicholson T , Deibert C , Andino J , Raheem O , Shin D , Doolittle J , Mehta A , Hehemann M , Campbell K , Eleswarapu S , Lundy S
Published: December 2024

Introduction

Despite a prevalence of nearly 1 in 10 men, male infertility remains incompletely understood and half of all diagnoses remain idiopathic despite extensive diagnostic workup. Even at large institutions, the rarity of many subpopulations of infertile men limits sample size and data quality.

Objective

We initiated an integrated multi-institutional research consortium to better under the pathogenesis of male infertility and improve our ability to conduct diverse, clinically relevant evidence-based research in this area.

Methods

A standardized 400-point database with advanced branching logic and automated calculation capabilities was generated and iteratively optimized using the HIPAA-compliant REDCap platform. Individual instruments were produced to capture demographic information, medical history, physical examination findings, lab and semen testing results, procedural and surgical data, and fertility outcomes. The database can be rapidly deployed at new institutions following completion of a standard data use agreement and is internally maintained by site investigators and exported at regular intervals for consortium-wide aggregation in a de-identified fashion.

Results

With the primary goal of pursuing collaborative and democratic research, the IRB-approved MOBYUS (Male Organ Biology Yielding United Science) consortium currently consists of at least twelve large US-based academic medical institutions. Data collection is ongoing with >4000 patients included to date with new projects are identified at regular monthly virtual meetings. The group has successfully published three proof-of-principle manuscripts to date.

Conclusions

As the field of urology and its subspecialties move towards collaboration and data-driven management, male infertility and its associated rare diseases may benefit from a decentralized network capable of leveraging large data sets. The MOBYUS Consortium aims to accomplish this goal for male infertility patients with an emphasis on generating the best possible clinical data for the patients suffering from this difficult condition. The collaborative approach adopted by the MOBYUS Consortium has the capability of rapidly generating a robust cohort for practice-shaping studies.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Fellow Health (Dr. David Shin, Stockholder); Posterity Health (Dr. Akanksha Mehta, Advisory Board Member); Boston Scientific Corporation (Dr. Marah Hehemann, Consultant); Coloplast Corporation (Dr. Marah Hehemann, Consultant); Endo International (Dr. Marah Hehemann, Speaker).
(079) RELIGION’S IMPACT ON DECISION MAKING AND COPING FOR MALE-FACTOR INFERTILITY COUPLES
Authors: Garcia Keeme-sayre A , Kassab J , Oppenheimer A , Duan M , Huang J , Stocks B , Lipshultz L
Published: December 2024

Introduction

With ideas such as God’s command to “be fruitful and multiply” in both Jewish and Christian texts and the Vatican’s disapproval of the use of in vitro fertilization (IVF), religious identities of male-factor infertility patients may affect how patients engage in reproductive health care.

Objective

The goal of this study is to assess the saliency of religious beliefs on the male-factor infertility patient.

Methods

A REDcap survey was sent to patients who presented for an infertility visit between 10/2/2022-10/2/2023. Using a 4-point Likert Scale and written responses, participants reflected on their religion’s role in their selection of treatment. Written responses were analyzed for common themes and results were reported using descriptive statistics.

Results

73% of respondents (n = 285/392) identified with a religion (90% a form of Christian, 3.2% Non-Orthodox Jewish, 3.2% Muslim, and 3.6% Other Religions). Non-Denominational (ND) or Protestant (P) Christians, Catholics, and Muslims reported that their religion encouraged the use of expanded infertility treatment rather than caused hesitancy (Table 1). Among written responses, IVF or Intrauterine Insemination was the most suggested infertility treatment (47.5% (n = 19/40)), and donor sperm or egg was the most discouraged (52% (n = 12/23)). Muslims were most likely to report discouragement of donor sperm or egg (n = 6/9 (66.7% of Muslims)). 243 participants provided written insight into their religious views of infertility treatment. Aside from no religious impact (45.7%), the most common themes were: no personal conflict with religious views (20.7%), reproduction as a core religious tenet (10.7%), and the unity of religion and science (9.9%). A small number of participants (7.9%) discussed having disagreed with or gone against their religion’s views, the majority of which were Catholic (n = 13/17 (76.5%)).

Conclusions

Religion was an encouraging factor for most male patients seeking infertility treatment. However, physicians should still take care to acknowledge differences among religions, recognizing that certain treatment options may cause discomfort in religious patients.

Disclosure

No.
(081) EXTERNAL SCATTERED RADIATION FROM PROSTATE CARCINOMA THERAPY AFFECTS BOTH GERM AND SOMATIC HUMAN TESTICULAR CELLS
Authors: Caldeira- Brant A , Martello R , Campos L , Reis AB , Samesima ET , Reis FM , Orwig KE , Chiarini-Garcia H
Published: December 2024

Introduction

Prostate cancer (PC) is the leading cancer type among men. While external radiation therapy (RT) is commonly utilized and successful in eradicating prostate cancer cells, its scattered radiation can potentially harm male fertility. There is limited understanding of how scattered radiation from RT impacts both germ and somatic cells in the testis of men with prostate cancer.

Objective

This study aims to evaluate the germ and Sertoli cells of adult men diagnosed with PC and who underwent RT.

Methods

Five men, aged between 60 and 78, who were fertile and diagnosed with prostate cancer (PC), underwent total external radiation therapy with doses ranging from 64 to 72 Gy for 32 to 40 days. They were later castrated between 15 and 24 months after treatment due to cancer recurrence. Additionally, testes were collected from five other patients, aged between 48 and 62, with advanced PC who had not undergone any prior treatment before castration, serving as the control group (NoT). Analysis of sex hormone levels, along with histological and immunohistochemistry (IHC) examinations, was conducted.

Results

Despite similar testosterone serum levels, FSH and LH were augmented in the RT group (Fig. 1). While 100% of NoT seminiferous tubules presented VASA+ germ cells, only 9% of RT tubules had them, with 70% and 21% showing Sertoli cell (SOX9+) only and fibrotic phenotypes, respectively (Fig. 2). Regarding germ cells, types Adark, Apale and B spermatogonia, and preleptotene spermatocytes were lower in RT (Fig. 3A), which was confirmed by MAGEA-4 spermatogonial immunostaining (Fig. 3B). In terms of undifferentiated spermatogonia, despite being reduced in the RT group (Fig. 4A), UTF1+ cells presented higher mitotic activity after IHC for MCM7 (Fig. 4B). 85% of MAGEA-4+ spermatogonia were undergoing apoptosis (CASPASE3+) in RT patients, whereas only 1% were found in NoT (Fig. 5). Concerning SOX9+ Sertoli cells, their number was not only lower in the RT group (Fig. 6A), but also showed increased apoptosis (Fig. 6B) and proliferation (Fig. 6C). Claudin-11 immunostaining revealed the presence of a blood-testis barrier protein in RT Sertoli cells, despite being more evenly organized in NoT patients (Fig. 7). Υ-H2AX immunostaining revealed DNA damage in both somatic and germ cells of RT patients.

Conclusions

The scattered radiation from radiation therapy disrupts the process of spermatogenesis in adult men by impacting both germ and Sertoli cells. Additionally, these cells notably decreased in RT patients compared to NoT patients. Surprisingly, it was also observed that Sertolli cell proliferation and apoptosis, as well as DNA damage, occurred even 2 years post-irradiation. In addition, the blood-testis barrier was severely affected in post-irradiation patients. Future studies should be conducted to investigate Sertolli’s cell proliferation.

Disclosure

No.
(082) EFFICACY OF EMLA CREAM FOR OFFICE-BASED ANDROLOGY PROCEDURE UNDER LOCAL ANESTHETIC: A RANDOMIZED CONTROLLED STUDY
Authors: Chung D , Bal D , Morra M , Shah J , Fidel M , Dhillon H , Nayak J , Patel P
Published: December 2024

Introduction

There has been an increasing number of office base urology procedure performed under local anesthesia (LA), although it can be associated with needle phobia and pain. EMLA (Eutectic Mixture of Local Anesthetic) is a topical anesthetic cream that is used in office-based urology procedures. However, its use in more involved/invasive andrology and male-infertility procedures such as hydrocelectomy, spermatocelectomy, and others remain poorly studied.

Objective

We hypothesized that pre-application of EMLA cream in office-based andrology and male-infertility procedures may provide better pain control and overall experience for patients.

Methods

A double-blinded randomized controlled trial was conducted for patients undergoing scrotal andrology surgeries under LA. Power calculation was performed with an estimated sample size of 72. Participants were randomly assigned in a 1:1 ratio to topical EMLA + LA vs LA alone. In the post-operative recovery area, patient will be asked to complete a VAS questionnaire rating pain with LA administration and pain with procedure. Analysis comparing VAS pain scores of both groups was performed using the independent sample t-test method.

Results

72 patients were included in our analysis, with 36 in the control and 36 in the intervention arm. For patient pain with administration of LA, the control arm reported an average VAS pain score of 4.31, compared to 3.72 in the intervention arm (p = 0.319). For patient pain with procedure, patients in the control arm reported a median VAS pain score of 3.47 compared to 3.03 (p = 0.432) in the intervention arm. Overall, 86% (62/72) of patients reported that they would either be “very likely” (4/5) or “highly likely” (5/5) to undergo future procedures under local anesthetic.

Conclusions

Performing scrotal surgeries under LA appears to be well tolerated and feasible option. Pre-application of EMLA cream does not appear to significantly patient reported outcomes.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific.
(088) TRENDS IN VARICOCELE SURVEILLANCE AND SURGICAL INTERVENTION IN CHILDREN AND ADOLESCENTS
Authors: Sweeney I , Chang J , Wiseman B , Merheb S , Sharadin C , Demarco R , Campbell K
Published: December 2024

Introduction

Varicocelectomy is often recommended in the setting of abnormal semen analyses, testicular atrophy, or associated testicular discomfort. Managing varicoceles in the adolescent populations is less clear because of the unknown impact on fertility. Expert consensus recommends adolescent patients diagnosed with varicocele undergo further evaluation to assess testicular growth. Varicocele surveillance trends including prevalence, length of follow-up, and indications for intervention are underreported. We report our experience with varicocele surveillance and the triggers for surgical intervention in the pediatric population at our institution.

Objective

We aim to characterize the selection of adolescent patients with varicocele participating in surveillance and the triggers for proceeding to varicocelectomy.

Methods

A single institutional retrospective review of electronic medical records from a tertiary referral center was performed. We evaluated pediatric patients ≤18 years old diagnosed with varicocele from 5/1/1993 to 5/31/2023. Varicocele diagnosis was identified using ICD 9 and 10 codes. Surveillance was defined as having at least one additional encounter for varicocele evaluation following the initial diagnosis. Testicular volumes were obtained by scrotal ultrasound and clinical assessment.

Results

96% of patients (380 of 395) had no varicocelectomy. 209 (53%) patients participated in surveillance. 9 of these patients eventually had a varicocelectomy. Indications for surgery in patients being surveilled included testicular pain (n = 4), testicular volume difference (n = 3 with a median testicular volume difference of 2.7 mL), and 2 patients with no reported indication. 186 (47%) patients had no surveillance period, 6 of which had a varicocelectomy. Indications for surgery in these patients included testicular pain (n = 2), testicular volume difference (n = 3 with a median testicular volume difference of 2.4 mL), and bilateral testicular hypotrophy (n = 1) with a total testicular volume of 10 mL. The median age at diagnosis was 15.05 years in the surveillance group and 15.5 years in the non-surveillance group.

Conclusions

Following diagnosis, only half of children and adolescent patients participated in surveillance of their varicocele. Rates of boys proceeding to varicocelectomy were very low and did not differ between patients seen at the primary visit and those who were followed for their varicocele. Our findings highlight the importance of maximizing patient counseling about varicoceles at diagnosis. Surveillance of young males with varicoceles requires patient, guardian, and provider education to counsel patients who may not otherwise undergo evaluation until infertility is encountered.

Disclosure

No.
(097) IMPACT OF PROSTATE CANCER ON SEXUAL QUALITY OF LIFE FOR FEMALE PARTNERS OF PATIENTS
Authors: Loeb S , Gupta N , Wittmann D , Nelson CJ , Salter CA , Rivera A , Byrne N , Sanchez Nolasco T , Zebib L , Garrett L , Schofield E , Mulhall J
Published: December 2024

Introduction

Prostate cancer diagnosis and treatment can have a significant impact on sexual quality of life for patients and their partners. We developed and validated a new instrument, the Sexual Concerns In Partners of Patients with Prostate cancer (SCIPPP-F), to measure sexual quality of life among female partners of patients with prostate cancer.

Objective

To examine scores on the SCIPPP-F questionnaire in 200 female partners from across the U.S. and factors associated with worse scores.

Methods

The SCIPPP-F survey includes 19 questions in 7 domains: 1) distress/satisfaction, 2) loss of connection as a couple, 3) active communication, 4) discomfort with communication, 5) frustration with sexual counseling, 6) expansion of sexual repertoire, and 7) non-penetrative sexual activity. All questions have 5 response choices (not at all, a little bit, somewhat, quite a bit, very much). Descriptive statistics were used to examine the distribution of survey responses, and the Mann–Whitney U test was used to compare median scores between subgroups of partners based on demographics and relationship characteristics.

Results

Results of the survey are shown in the table. More than half of partners (53%) felt their sex life is quite a bit or very much worse since the prostate cancer diagnosis and/or treatment, and 35% were not at all satisfied with their current sex life. Loss of intimacy was a common complaint. Additionally, approximately 1/3 of partners were at least somewhat uncomfortable talking to their partner about sexual problems and frustrated/angry about the lack of information they received about sexual health from clinicians, with 51 partners (26%) reporting that they were not at all prepared for sexual side effects. Notably, the majority of partners were at least somewhat comfortable trying new ways to achieve intercourse and at least somewhat satisfied with hugging, kissing, and other intimate activities rather than intercourse. There were no significant differences in median overall SCIPPP-F scores based on partners’ marital status, relationship length (>30 vs < =30 years), or menopausal status; however, there was a trend toward lower (better) SCIPPP-F scores among non-white partners (p = 0.07).

Conclusions

These results identify multiple actionable gaps in sexual quality of life for female partners of patients with prostate cancer, including a need for more comprehensive sexual counseling prior to treatment and interventions to improve sexual quality of life, such as individual/couples counseling and/or sex therapy. Funding acknowledgement: Department of Defense.

Disclosure

No.
(100) DEPRESSION IN MEN UNDERGOING FERTILITY TESTING IS NEGATIVELY ASSOCIATED WITH SEXUAL FUNCTION
Authors: Seyer A , Nolte D , Kenfield S , Belarmino A , Civello D , Smith J , Helo S
Published: December 2024

Introduction

Depression is a common mental health disorder affecting men of reproductive age. Depression or depressive symptoms may impact a variety of health factors, including sexual function. Trying to conceive may contribute to additional stress and negative emotions for the couple.

Objective

To determine the rate of sexual dysfunction in men with depression who are undergoing fertility testing.

Methods

A review was performed of a prospectively maintained database of men utilizing a mail-in semen analysis test system developed by Fellow Health, Inc. Men ≥18 years were included if they consented to participate in research and completed survey questionnaires on both their quality of life and sexual function. Depression level (normal, mild, moderate, or severe) was derived via the short-form depression assessment developed by the Patient Reported Outcomes Measurement Information System (PROMIS). The sexual function survey assessed libido, orgasmic and ejaculatory dysfunction, intercourse frequency, Erection Hardness Score, and IIEF-5 score. Descriptive statistics were reported and chi-squared tests were used to determine statistical significance at the 0.05 alpha level.

Results

Of the 2125 men included, 15.2% reported mild depression and 12.8% moderate or severe depression. The presence of depression was negatively associated with libido, with 11.2% of men with normal levels of depression reporting terrible or poor libido compared to 18.7% with mild depression and 22.2% with moderate or severe depression, p < 0.001. Compared to men without depression, those with moderate or severe depression were nearly twice as likely to report ejaculatory dysfunction (17.2% vs. 29.7%) and three times as likely to report orgasmic dysfunction (3.9% vs. 13.0%), p < 0.001 for all. Severity of depression was also predictive of an erection sufficient for penetration: whereas 96.8% of those with normal levels of depression reported an erection sufficient for penetration, the same could be said for only 94.5% of those with mild depression and 92.5% of those with moderate or severe depression (p < 0.001). Only 53.1% of men with moderate or severe depression had an IIEF-5 score greater than 21 (i.e., “No signs of ED”), compared to 60.9% with mild depression and 75.8% without depression, p < 0.001. Importantly, men with moderate to severe depression were more than twice as likely to report intercourse frequency less than once weekly (18.0%) as opposed to men without depression (7.4%), p < 0.001.

Conclusions

The presence of depression in men undergoing fertility testing is negatively associated with libido, ejaculatory, orgasmic, and erectile function.

Disclosure

Any of the authors act as a consultant, employee or shareholder of an industry for: Fellow Health.
(107) IDENTIFYING PREDICTORS OF LOW TESTOSTERONE LEVELS IN MEN WITH TESTICULAR CANCER AFTER RADICAL ORCHIECTOMY
Authors: Flores Martinez J , Ljubetic BM , Liso N , Mulhall JP
Published: December 2024

Introduction

It is well known that there is a risk of low testosterone (T) after radical orchiectomy (RO) in men with testicular cancer (TC).

Objective

We aimed to identify predictors of low T levels in men after RO for TC.

Methods

Men treated with RO for TC who had a total testosterone (T) level measured before surgery and within 12 months after RO were included. Men with chemotherapy after surgery, a history of T replacement, and men with synchronous or metachronous bilateral TC were excluded. Additional parameters of interest included patient demographics, and testis ultrasound (TUS) factors: volume of non-cancerous testis, number of tumors, tumor laterality, presence of microcalcifications, TC markers, and TC pathology. LCMS was used to measure total T. Low T was defined as a total T level < 300 ng/dL. A significant difference between pre and post-RO was any increase/decrease ≥100 ng/dL. Multivariable analysis (MVA) explored predictive factors associated with low T in this population.

Results

120 men were included. The median age was 34 (28, 38) years. Median baseline total T levels were 467 (324, 699) ng/dL. 22% had low T prior to surgery. Median beta-HCG, alpha-fetoprotein, and lactate dehydrogenase were 2.3 (0.8, 24) mIU/mL, 3.7 (2.4, 13.5) ng/mL, 191 (164, 242) U/L. TUS: median testis volume 15 (11, 21) cc. 43% had right RO, 57% left RO, 72% had a single mass, 28% ≥2 masses. 43% of the TUS showed microcalcifications. 81% had seminoma, 38% embryonal carcinoma, 29% Yolk sac tumor, 26% teratoma, 3% choriocarcinoma, and 3% other findings. Median total T levels after surgery were 457 (306, 636) ng/dL. Median time T levels measured after RO was 6 (3, 12) months. 23% had low T postop. 13% of individuals who did not exhibit low T prior to RO subsequently developed low T, 54% of those initially presenting with low T continuing to experience this condition post-surgery, while 46% of the low T before surgery cases resolved after RO. Median change in T levels pre vs post-RO was –20 (-159, 180) ng/dL. Post-surgery, total T levels increased significantly in 29% and decreased significantly in 33%. On MVA, only pre-RO low T was a predictor of low T after surgery in men with TC. (Table).

Conclusions

Around a quarter of men have low T before and after RO in men with TC, and pre-RO low T is a significant predictor of low T after surgery.

Disclosure

No.
(108) SERUM TESTOSTERONE LEVEL AS A PREDICTOR OF BIOCHEMICAL RECURRENCE IN MEN WITH PROSTATE CANCER
Authors: Mulhall J , Liso N , Elshafei A , Flores J
Published: December 2024

Introduction

The literature has engaged in a discussion regarding the potential connection between total testosterone (TT) levels and biochemical recurrence (BCR) in individuals diagnosed with prostate cancer (PC).

Objective

We herein explore the relationship between preoperative TT levels and the BCR rates in these men.

Methods

We retrospectively reviewed the records of 1599 men with PC treated by RP. We excluded men who had androgen deprivation therapy (ADT) prior to RP or within 3 months after RP from the study. Morning TT levels measured by LCMS within 3 months of RP with low TT defined as <300 ng/dl. BCR defined by two consecutive postoperative prostate specific antigen (PSA) levels of ≥0.1. Univariate analysis (UVA) was used to examine predictors of BCR. Variables included in the analysis were age, comorbid conditions pretreatment PSA, clinical T stage, biopsy GG, peri-operative TT, and adverse pathological features at RP (extracapsular extension (ECE), seminal vesical invasion (SVI), positive surgical margins (PSM), lymph node invasion (LNI)). Multivariable analysis (MVA) was conducted using those factors found to be significant on UVA.

Results

1599 men analyzed. Median age 63 (57, 68) years, median follow up of 62 (18115) months. Pre-RP PSA 6 (4,9) ng/ml, TT 447 (343, 575) ng/dl. Median GGG 2 (2, 3). 57% had ECE, 12% SVI, 22% PSM, 14% LNI. BCR occurred in 26% of men with a median time of 28 (5.7, 66.6) months. On MVA, higher biopsy GGG, clinical stage ≥T2b, higher pre-RP PSA, and adverse pathological features at RP were independent predictors of BCR, while peri-operative TT (≤300 ng/dl) was not associated with BCR. (Table) Additionally, we did not identify any association between extremely low TT levels (≤200 ng/dl) and BCR.

Conclusions

TT was not associated with biochemical recurrence in men after RP.

Disclosure

No.
(113) WHY DO NEOURETHRAL STRICTURES COMMONLY OCCUR AT THE PROXIMAL NEOURETHRA? A NOVEL THEORY, AND SIGNIFICANT REDUCTION IN STRICTURE INCIDENCE AFTER INITIATING USE OF A NEW POST-SURGERY DEVICE
Authors: Lin J , Sandhu S , Mallavarapu S , Smith S , Ray E , Garcia M
Published: December 2024

Introduction

Transgender men (TM) seeking phalloplasty must choose between phalloplasty with- (P + UL) and without urethral lengthening (P-UL). Those seeking P + UL must be counselled about the risks of neourethral strictures (NUS) and urethrocutaneous fistulae (UCF), whose incidence is reported at 25-63% and 22-75%, respectively. A decision-making tool to aid in surgical decision-making has not been described. Because tissue ischemia commonly causes NUS and UCF, strategies must be implemented to prevent this.

Objective

1) Develop a decision-making tool comparing P + UL/P-UL. 2) Evaluate what proportion of our TM choose P + UL/P-UL before and after implementation of our decision-making tool. 3) Develop a means to reduce neourethral ischemia postoperatively. 4) Evaluate NUS and UCF requiring surgical repair after P + UL, before and after initiating our “Manny Pack” protocol.

Methods

Single-center, retrospective, chart review of all patients undergoing phalloplasty from July/2017–May/2024. Subjects were divided based on urethral lengthening status before and after implementing our decision-making tool (comparison-table of each option’s pro’s/con’s). We report the incidence of NUS and UCF before and after initiation of our “Manny-pack” to support the neophallus for 3-months postoperatively.

Results

67 patients underwent phalloplasty over ~6-years. 35/67(51.6%) patients underwent P + UL. After initiation of our decision-making tool, the proportion of TM choosing P + UL decreased significantly from 30/49(61.2%) to 5/18(27.8%) (p = 0.009). Our incidence of NUS and UCF was 3/32 (9.4%) and 7/32 (21.9%), respectively. After initiation of our “Manny-pack” (Fig. 1) protocol, the incidence of NUS and UCF requiring surgical intervention decreased to zero (0%).

Conclusions

Debut of our decision-making tool significantly increased the proportion of TM who chose lower-risk P-UL. Our “Manny Pack” supports the neophallus and proximal neourethra for 3-months after surgery with privacy, and promotes normal activity (Fig. 1). This is the first report to propose that supporting the phallus reduces kinking of the proximal neourethra, causing ischemia exactly where NUS typically occur. (Figure 2) The significantly decreased incidence of NUS and UCF requiring surgery that we observed supports this theory.

Disclosure

No.