Citations

Objectives To evaluate the pre‐ and intraoperative variables that impact the integrity of the corporal bodies over time after inflatable penile prosthesis (IPP) placement, as predictors of intraoperative corporal perforation and delayed cylinder complications have not been well characterized. Patients and Methods We retrospectively reviewed a 16‐centre multi‐institutional database of IPP surgeries performed by experienced implanters from 2016 to 2021. Poor corporal integrity (PCI) was defined as intraoperative (iPCI) corporal complications or postoperative (pPCI) corporal complications. Multivariable analysis was performed to identify independent predictors of PCI, iPCI, and pPCI. Primary outcomes included intra‐ and postoperative corporal complications. Results We identified 5153 patients for analysis from 5406 IPP cases, finding 152 (2.95%) cases of PCI. On multivariable analysis, predictors of PCI included revision IPP surgery (odds ratio [OR] 8.16, 95% confidence interval [CI] 5.15–12.92; P < 0.001), sequential dilatation (OR 2.12, 95% CI 1.32–3.39; P = 0.002), coronary artery disease (CAD)/peripheral vascular disease (PVD) (OR 1.81, 95% CI 1.18–2.77; P = 0.006), older age (OR 1.02, 95% CI 1.01–1.04; P = 0.013), and corporal scarring (OR 1.58, 95% CI 1.0–2.5; P = 0.049). Predictors of iPCI included revision IPP surgery (OR 7.34, 95% CI 4.18–12.88; P < 0.001), corporal scarring (OR 2.77, 95% CI 1.64–4.69; P < 0.001), radiation therapy (OR 2.25, 95% CI 1.0–5.04; P = 0.049), and older age (OR 1.03, 95% CI 1.0–1.05; P = 0.025). Revision IPP surgery (OR 7.92, 95% CI 3.69–17.01; P < 0.001), sequential dilatation (OR 3.4, 95% CI 1.61–7.19; P = 0.001), CAD/PVD (OR 2.98, 95% CI 1.56–5.72; P = 0.001), and history of priapism (OR 3.59, 95% CI 1.08–11.99; P = 0.038) were predictive of pPCI. Conclusion Coronary artery disease/PVD, being of older age, having corporal scarring, undergoing IPP revision surgery and sequential dilatation were predictive risk factors for complications associated with PCI. Identifying patients who are at risk of having PCI may improve patient‐specific counselling, consideration of referral to more experienced implanters, and surgical planning to potentially promote longer‐term device viability.

Abstract Objectives Fluorescence resonance energy transfer (FRET)–based ADAMTS13 activity assays are critical for the diagnosis of thrombotic thrombocytopenic purpura. However, these assays are susceptible to interference. As iodide has been suggested to interfere in laboratory testing via fluorophore quenching or promotion, we aimed to determine whether iodinated contrast (Omnipaque) interferes with the ATS-13 ADAMTS13 Activity Assay 2.0. Methods We evaluated the excitation, emission, and absorbance spectrum of Omnipaque alone and spiked in patient plasma with known ADAMTS13 activity and ADAMTS13 activity on Omnipaque alone, an abnormal control of patient plasma previously observed to display elevated baseline relative fluorescent units, and variable concentrations of patient plasma with known ADAMTS13 activity spiked with Omnipaque. Results No atypical fluorescent peaks were observed on any sample (Omnipaque alone or spiked in plasma) between 250 and 700 nm. There was no difference in the mean ADAMTS13 activity among the various concentrations of plasma spiked with Omnipaque or plasma spiked with saline. Conclusions Iodinated contrast does not appear to interfere—either via spectral overlap of the fluorophore or through physiologic inhibition of the ADAMTS13 enzyme—with ADAMTS13 activity FRET-based assays based on the findings from this in vitro analysis. Delaying sample collection for ADAMTS13 activity testing from suspected patients with thrombotic thrombocytopenic purpura following administration of iodinated radiocontrast agents is not necessary, and recent contrast administration should not yield erroneous ADAMTS13 activity results.

Abstract Background The National Clinical Trials Network (NCTN) is the largest government-sponsored organization in the United States; it is tasked with funding randomized controlled trials in oncology. It is unknown whether there are differences in study design by treatment modality. We evaluated differences in methodology between trials testing radiation therapy (RT) vs systemic therapy. Methods The Clinical Trials Support Unit website was used to identify active randomized controlled trials of systemic therapy or RT across NCTN cooperative groups through December 31, 2023. Studies in disease sites with more than 5 RT trials were included. Each trial’s protocol was reviewed to obtain key design information that was descriptively compared: primary endpoint, hypothesis testing type (superiority vs noninferiority), noninferiority margin, hypothesized effect size, power, and statistical significance level. Results A total of 186 randomized controlled trials (142 systemic therapy, 44 RT) were examined. Comparing primary endpoints, 59.1% vs 26.8% of RT vs systemic therapy trials, respectively, had a primary endpoint of overall survival. Nearly one-third (31.2%) of RT trials were noninferiority vs 6.3% of systemic therapy trials. Among breast cancer trials, 75% of RT studies were noninferiority vs 11.1% systemic therapy. Target effect size, power, and statistical significance level were similar by treatment modality within tumor types and disease settings. Conclusion Among NCTN cooperative group randomized controlled trials, there were marked differences in study design between RT vs systemic therapy trials. A higher benchmark for defining success for RT interventions was observed, with greater emphasis on overall survival as the primary endpoint. This finding may reflect differences in therapeutic mechanism by modality and types of study questions posed.

Abstract Context Diagnosing adrenal insufficiency (AI) often requires complex testing, which can be time-consuming and expensive. Dehydroepiandrosterone sulfate (DHEAS) is a promising marker of hypothalamic-pituitary-adrenal axis function; however, its diagnostic performance has not yet been evaluated in a large-scale study. Objective Evaluate the performance of DHEAS and baseline cortisol in assessing AI. Design Single-center retrospective cohort study. Setting Referral center. Patients Adults who underwent cosyntropin stimulation testing (CST) between 2005 and 2023 and had DHEAS measured within 3 months prior to CST. Main Outcome Measures Area under receiver operating characteristic curve (AUROC) for DHEAS and baseline cortisol. Prevalence of AI based on various DHEAS and baseline cortisol concentrations. Results Among 1135 patients, 195 (17.2%) had AI. Both baseline cortisol and DHEAS independently had good diagnostic performance with AUROC 0.81 [95% confidence interval (CI) 0.77-0.84 and 0.81 (95% CI 0.78-0.85)], respectively. Time of CST performance had no significant effect on diagnostic accuracy of baseline cortisol while recent glucocorticoid use decreased diagnostic performance of DHEAS (AUROC 0.72 vs 0.83). Only 1.2% of patients with baseline cortisol ≥10 mcg/dL had AI based on CST. Among patients with baseline cortisol between 5 and 9.9 mcg/dL, only 1.3% had AI if DHEAS was ≥60 mcg/dL. Conversely, the majority (72.2%) of patients with both baseline cortisol &lt;5 mcg/dL and DHEAS &lt;25 mcg/dL were found to have AI. Conclusion DHEAS has good diagnostic performance in assessing AI. Measuring both baseline cortisol and DHEAS concentrations may eliminate the need for further dynamic testing in many patients.

Abstract Struma ovarii (SO) is a rare subtype of ovarian teratoma composed of more than 50% thyroid tissue. Extraovarian spread of SO, called peritoneal strumosis, was previously considered benign given the lack of histological malignant features. However, the 2020 World Health Organization Classification of Female Genital Tumors reclassified peritoneal strumosis as highly differentiated follicular carcinoma of ovarian origin (HDFCO), highlighting its low-grade malignant potential. We present a 38-year-old woman with SO treated initially with right salpingo-oophorectomy, with recurrence 2 years later with multifocal metastatic lesions in the abdomen and pelvis that was successfully treated with surgical resection, total thyroidectomy, and 157 mCi of I-131. Tumor molecular testing revealed a pathogenic DICER1 variant (c.5428G&gt;T, exon 25). A second variant (c.319delinsTGCTGGTTTGACA, exon 4) was of uncertain significance. Germline testing confirmed the second DICER1 variant and also identified an increased risk variant in the APC gene (c.3920T&gt;A). This is a rare case of extensive HFDCO with DICER1 variants, which has been associated with thyroid cancer. Given the germline DICER1 variant, this may also represent the first reported instance of DICER1 syndrome manifesting as HDFCO. Further research into the prognostic factors and optimal treatment of HFDCO is needed.

Abstract Background Sexual minority women (SMW) have worse mental and physical health outcomes compared to heterosexual women, but literature on sexual function in SMW compared to heterosexual women is lacking. Aim To evaluate sexual function and sexual distress in women across sexual orientations. Method Questionnaire data were analyzed for women aged 18 and older who presented to women’s health clinics at Mayo Clinic in Minnesota, Arizona, and Florida from 2016 to 2023. Female Sexual Function Index (FSFI) and Female Sexual Distress Scale–Revised (FSDS-R) scores assessed sexual dysfunction (FSFI ≤ 26.55 and FSDS-R ≥ 11). Multivariable logistic models adjusted for confounding factors. Outcomes Our main outcome was female sexual dysfunction as defined by a composite of FSFI ≤ 26.55 and FSDS-R ≥ 11 to include both sexual function and sexual distress. Results Of 6241 sexually active women, 3% were SMW and 97% were heterosexual women. The majority were White (93%), with average age 51.6 years old. There was no significant difference in sexual dysfunction rates between heterosexual and SMW by combined endpoint on univariate or multivariable analysis. SMW had higher total FSDS scores (17 vs 15, P = 0.037), indicating more sexual distress. Clinical Implications Sexual health concerns may differ between SMW and heterosexual women emphasizing the need for inclusive, culturally competent care. Strengths & Limitations This study assessed the association of sexual orientation and sexual dysfunction by incorporating sexual functioning problems and sexual distress. Limitations include a small number of SMW and a predominantly White, married, employed, and educated study sample, limiting the generalizability of the findings. Conclusion Rates of sexual dysfunction were similar between mostly White SMW and heterosexual women presenting to tertiary care centers. SMW reported more sexual distress than heterosexual women. Evaluating these variables in larger, more diverse cohorts is a critical next step.

Abstract Introduction Inflatable penile prosthesis (IPP) surgery is a well-established treatment for erectile dysfunction (ED). There is little information in the literature regarding the utilization of perioperative antimicrobial prophylaxis in primary and revision IPP surgeries. Objective We investigated the patterns of perioperative antimicrobial prophylaxis among a large multinational cohort of primary and revision IPP surgeries. Methods We conducted a retrospective analysis of 5400 patients (4187 primary IPP patients and 849 revision IPP patients) from our Prosthetic Urology Multi-Institutional Partnership (PUMP) institutions. Usage data for intravenous (IV), preoperative oral, and postoperative oral antimicrobials were analyzed. We specifically assessed patient profiles, antimicrobial selection, and antimicrobial duration. Multivariate statistical analyses were conducted to identify significant variations between primary and revision surgeries. Results For patients undergoing primary IPP placement, 81.9% received IV antibiotics for &lt;24 hours whereas 18.1% received IV antibiotics for &gt;24 hours. Preoperative oral antimicrobials were used in 59.4% of patients and 99.4% received postoperative oral antimicrobials. The overall infection rate for primary implants was 2%. Notably, quinolone administration shows a higher postoperative infection rate (11.4%) compared to gentamicin (1.9%), cephalosporin (0%), and vancomycin (1.0%). Multivariable regression analysis identifies factors such as a history of infection, diabetes, and priapism as predictors for postoperative infections. Furthermore, the study finds that perioperative antifungal use is associated with a decreased risk of infection. Conclusions This study provides valuable insights into the patterns of perioperative antimicrobial prophylaxis. Duration, type, and route of antibiotics given preoperatively or postoperatively do not affect postoperative infection rates among high volume prosthetic urologists. Giving IV antibiotics for more than 24 hours does not affect postoperative infection. Perioperative antifungals are a protective factor. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus.