Fragility of overactive bladder medication clinical trials: A systematic review.

PURPOSE: Overactive bladder (OAB) syndrome significantly impairs quality of life, often necessitating pharmacological interventions with associated risks. The fragility of OAB trial outcomes, as measured by the fragility index (FI: smallest number of event changes to reverse statistical significance) and quotient (FQ: FI divided by total sample size expressed as a percentage), is critical yet unstudied. MATERIALS AND METHODS: We conducted a systematic search for randomized controlled trials on OAB medications published between January 2000 and August 2023. Inclusion criteria were trials with two parallel arms reporting binary outcomes related to OAB medications. We extracted trial details, outcomes, and statistical tests employed. We calculated FI and FQ, analyzing associations with trial characteristics through linear regression. RESULTS: We included 57 trials with a median sample size of 211 participants and a 12% median lost to follow-up. Most studies investigated anticholinergics (37/57, 65%). The median FI/FQ was 5/3.5%. Larger trials were less fragile (median FI 8; FQ 1.0%) compared to medium (FI: 4; FQ 2.5%) and small trials (FI: 4; FQ 8.3%). Double-blinded studies exhibited higher FQs (median 2.9%) than unblinded trials (6.7%). Primary and secondary outcomes had higher FIs (median 5 and 6, respectively) than adverse events (FI: 4). Each increase in 10 participants was associated with a +0.19 increase in FI (p < 0.001). CONCLUSIONS: A change in outcome for a median of five participants, or 3.5% of the total sample size, could reverse the direction of statistical significance in OAB trials. Studies with larger sample sizes and efficacy outcomes from blinded trials were less fragile.

Clinical applications of artificial intelligence in robotic surgery.

Artificial intelligence (AI) is revolutionizing nearly every aspect of modern life. In the medical field, robotic surgery is the sector with some of the most innovative and impactful advancements. In this narrative review, we outline recent contributions of AI to the field of robotic surgery with a particular focus on intraoperative enhancement. AI modeling is allowing surgeons to have advanced intraoperative metrics such as force and tactile measurements, enhanced detection of positive surgical margins, and even allowing for the complete automation of certain steps in surgical procedures. AI is also Query revolutionizing the field of surgical education. AI modeling applied to intraoperative surgical video feeds and instrument kinematics data is allowing for the generation of automated skills assessments. AI also shows promise for the generation and delivery of highly specialized intraoperative surgical feedback for training surgeons. Although the adoption and integration of AI show promise in robotic surgery, it raises important, complex ethical questions. Frameworks for thinking through ethical dilemmas raised by AI are outlined in this review. AI enhancements in robotic surgery is some of the most groundbreaking research happening today, and the studies outlined in this review represent some of the most exciting innovations in recent years.

Electric Bicycle Injuries and Hospitalizations.

This cross-sectional study investigates injury trends associated with electric bicycles in the US from 2017 to 2022.

Conservative Management of Penile and Urethral Lichen Sclerosus: A Systematic Review.

PURPOSE: We evaluate the efficacy and safety profiles of currently available conservative management options for penile and urethral lichen sclerosus. MATERIALS AND METHODS: A systematic review of existing literature on lichen sclerosus was conducted utilizing the PubMed, Embase, and Web of Science databases. References were assessed for relevance to nonsurgical management of male genital lichen sclerosus by title and abstract by 3 independent reviewers, then reviewed in full and in duplicate by 5 independent reviewers. RESULTS: Seventeen studies describing conservative management of histologically confirmed penile and urethral lichen sclerosus in male patients were included in the final review. We present available evidence supporting the use of 4 major treatment modalities represented in the existing literature: topical corticosteroids, tacrolimus, platelet-rich plasma, and CO2 laser. We also briefly discuss the limited studies on the use of oral acitretin and polydeoxyribonucleotide injections. Outcomes assessed include symptoms, clinical appearance, quality of life, sexual satisfaction, adverse effects, and long-term efficacy of treatment. CONCLUSIONS: Topical corticosteroids remain the mainstay of conservative management of penile and urethral lichen sclerosus, with current literature supporting the use of other therapies such as tacrolimus and platelet-rich plasma as alternatives or adjuvant treatments when escalation of treatment is necessary. Future research should further explore the efficacy and safety of newer therapies through additional controlled clinical trials in the targeted population.

Real-World Complications of the SpaceOAR Hydrogel Spacer: A Review of the Manufacturer and User Facility Device Experience Database.

OBJECTIVE: To characterize adverse events related to use of the perirectal spacing agent SpaceOAR, we examined the Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried for "SpaceOAR" and "Augmenix" from June 2015 (when SpaceOAR was approved by the Food and Drug Administration) to October 2022. Reports were reviewed for adverse events (AEs), operative procedures performed because of the AE, and changes to the radiation plan. AEs were categorized using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. RESULTS: Six hundred fifty-four reports were reviewed. Eighty-four were excluded and 4 reports reviewed 2 separate cases of SpaceOAR administration. Five hundred seventy-four cases were ultimately included. Three deaths were reported (0.5% of all AEs). One point six percent of cases represented CTCAE grade 4 injuries (life-threatening consequences; urgent intervention indicated), 15.9% grade 3 (severe but not immediately life-threatening; hospitalization), 24.2% grade 2 (moderate; local/noninvasive intervention), and 57% of events were CTCAE grade 1 (mild; asymptomatic or mild symptoms). Bowel diversion occurred in 29 cases (9%). CONCLUSION: Both asymptomatic (n = 311) and debilitating (n = 12) complications of SpaceOAR hydrogel use were identified. Death, gel embolization, anaphylaxis, rectal ulcerations, and infections requiring bowel or urinary diversions were among the complications reviewed. Providers should consider these potential complications before perirectal spacer administration and during patient counseling.

Rheumatic masqueraders: mimics of primary vasculitis - a case-based review.

INTRODUCTION: Vasculitis conditions are often serious and sometimes fatal diseases, therefore it is paramount to diagnose correctly and treat appropriately. Mimics of primary vasculitis can include either non-inflammatory syndromes or secondary vasculitis where the underlying etiology of the vasculitis is being driven by infection, malignancy, drug-effect or other. AREAS COVERED: This review comprises six individual cases of vasculitis mimics. Each case is presented and the clinical, radiographic, and histological features that distinguish the case from primary vasculitis are highlighted. Key mimics in large, medium and small vessel vasculitis are outlined. EXPERT OPINION: The diagnosis of vasculitis requires a comprehensive assessment of clinical, radiographic, and histologic features. Clinicians should be familiar with mimics of primary vasculitis conditions. In the case of non-inflammatory mimics, it is important to differentiate from primary vasculitides in order to avoid unnecessary and potentially harmful immunosuppression. For cases of secondary vasculitis, identification of the correct etiologic cause is critical because treatment of the underlying stimulus is necessary for successful management and outcomes.

Safety and Feasibility Study of Autologous Engineered Urethral Constructs for the Treatment of Strictures: Clinical Trial Update.

Autologous engineered urethral constructs are a promising treatment option for definitive management of long and complex urethral strictures, with the prospect of eliminating stricture recurrence.

Large vessel involvement in antineutrophil cytoplasmic antibody-associated vasculitis.

OBJECTIVES: Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is currently categorized under the small vessel vasculitides. There is limited knowledge about large vessel involvement in AAV (L-AAV), mainly described in case reports and small series. L-AAV can involve temporal arteries (TA-AAV), aorta (A-AAV), and periaortic soft tissue (PA-AAV). We sought to characterize the features of patients with L-AAV. METHODS: Patients older than 18 years at diagnosis of TA-AAV, A-AAV and PA-AAV seen at the Mayo Clinic, Rochester between January 1, 2000, and December 31, 2021, were identified through a proprietary medical text search algorithm. Patients were included if diagnosed with L-AAV, fulfilled 2022 ACR/EULAR classification criteria for GPA, MPA, or EGPA, had positive ANCA test results, and had more than one outpatient or inpatient visit. RESULTS: The study cohort consists of 36 patients with L-AAV. Of those, 23 had p-ANCA and/or MPO-ANCA; 13 had c-ANCA and/or PR3-ANCA. Mean (SD) age at AAV diagnosis was 63.4 (12.79); 20 (56%) were male. Seventeen patients had TA-AAV, 10 had A-AAV and 9 had PA-AAV. Most patients (n = 25, 69%) were diagnosed with large vessel vasculitis and AAV within a one-year timespan. Twenty-five (69%) patients had histopathologic confirmation of AAV diagnosis in a location other than temporal artery, aorta, or periaortic soft tissue. Glucocorticoids (36/36), rituximab (19/36), and methotrexate (18/36) were the most frequent treatments. CONCLUSIONS: This is the largest single-center cohort of patients with L-AAV to date. AAV can involve large arteries, albeit infrequent. AAV-targeted therapy should be considered in patients with L-AAV.

Urethral Slings for Irradiated Patients With Male Stress Urinary Incontinence: A Meta-analysis.

OBJECTIVE: To systematically compare success, cure and complication rates of urethral sling surgeries in stress urinary incontinence patients with and without a history of pelvic radiotherapy (RT). MATERIALS AND METHODS: We searched PUBMED, EMBASE, and Web of Science to identify relevant articles. The primary outcomes were the success and cure rates. The secondary outcomes included the rates of infection, urethral erosion, total complications, explantation, and satisfaction. Outcomes were analyzed using a random-effects model to calculate the unadjusted odds ratio (OR) in patients with a history of RT compared with those without prior RT. RESULTS: On pooled analysis, we found significantly lower odds of success (OR 0.68; 95% confidence interval [CI] 0.53-0.87, P < .001) and cure (OR 0.67; 95% CI 0.55-0.82, P < .001) in radiated patients than in nonirradiated patients. Subgroup analysis by type of sling showed significantly lower odds of success in Advance subgroup (OR 0.66; 95% CI 0.45-0.95, P < .001) and significantly lower odds of cure in Advance (OR 0.59; 95% CI 0.36-0.95, P < .001) and Atoms subgroups (OR 0.70; 95% CI 0.54-0.93, P < .001). We also found significantly greater odds of sling explantation (OR 2.93; 95% CI 1.62-5.29, P < .001) and infection (OR 3.06, 95% CI 1.03-9.07, P < .001) in radiated patients than in nonradiated patients. CONCLUSION: Patients with a history of pelvic RT have lower odds of success and cure and higher odds of infection and sling explantation than those without a history of pelvic RT.

Impact of sex and comorbid diabetes on hospitalization outcomes in acute pancreatitis: A large United States population-based study.

Backgrounds: Data on the association between comorbid diabetes mellitus (DM) and acute pancreatitis (AP) remains limited. Utilizing a large, nationwide database, we aimed to examine the impact of comorbid diabetes mellitus on patients admitted for acute pancreatitis. Methods: This was a retrospective case-control study of adult patients with AP utilizing the National Inpatient Sample from 2015-2018, using ICD-10 codes. Hospitalization outcomes of patients admitted for AP with comorbid DM were compared to those without comorbid DM at the time of admission. The primary outcome was a mortality difference between the cohorts. Multivariable-adjusted cox proportional hazards model analysis was performed. Data was analyzed as both sex aggregated, and sex segregated. Results: 940,789 adult patients with AP were included, of which 256,330 (27.3%) had comorbid DM. Comorbid DM was associated with a 31% increased risk of inpatient mortality (aOR: 1.31; p = 0.004), a 53% increased risk of developing sepsis (aOR: 1.53; p = 0.002), increased hospital length of stay (LOS) (4.5 days vs. 3.7 days; p < 0.001), and hospital costs ($9934 vs. $8486; p < 0.001). Whites admitted for AP with comorbid DM were at a 49% increased risk of mortality as compared to Hispanics (aOR: 1.49; p < 0.0001). Different comorbidities had sex-specific risks; men admitted for AP with comorbid DM were at a 28% increased risk of mortality (aOR: 1.28; p < 0.0001) as compared to women. Men with comorbid DM plus obesity or hypertension were also at increased risk of mortality as compared to women, whereas women with comorbid DM plus renal failure were at greater risk of mortality as compared to men. Conclusions: Comorbid DM appears to be a risk factor for adverse hospitalization outcomes in patients admitted for AP with male sex and race as additional risk factors. Future prospective studies are warranted to confirm these findings to better risk stratify this patient population.

WITHDRAWN: Non-Anti-TNF Biologics as Salvage Therapy for Refractory Acute Severe Ulcerative Colitis, A Systematic Review

Since the authors are not responding to the editor's requests to fulfill the editorial requirement, therefore, the article has been withdrawn.Bentham Science apologizes to the readers of the journal for any inconvenience this may have caused.The Bentham Editorial Policy on Article Withdrawal can be found at https://benthamscience.com/editorial-policies-main.php BENTHAM SCIENCE DISCLAIMER: It is a condition of publication that manuscripts submitted to this journal have not been published and will not be simultaneously submitted or published elsewhere. Furthermore, any data, illustration, structure or table that has been published elsewhere must be reported, and copyright permission for reproduction must be obtained. Plagiarism is strictly forbidden, and by submitting the article for publication the authors agree that the publishers have the legal right to take appropriate action against the authors, if plagiarism or fabricated information is discovered. By submitting a manuscript, the authors agree that the copyright of their article is transferred to the publishers if and when the article is accepted for publication.

Dual Antiplatelet Therapy Does Not Increase Bleeding Risk in Percutaneous Gastrostomy Tube Placement: Network Meta-Analysis.

BACKGROUND/OBJECTIVE: Gastrostomy tube (G tube) is a commonly performed procedure for nutritional support. Current guidelines recommend discontinuation of dual antiplatelet therapy (DAPT) prior to G tube placement to reduce bleeding risk. AIMS: We aim to compare bleeding risk in single, dual and no antiplatelet therapy during G tube placement. METHODS: We searched PubMed, Embase, Cochrane, and Web of Sciences to include comparative studies evaluating single antiplatelet (aspirin, clopidogrel), dual antiplatelet (DAPT, aspirin and clopidogrel), and no antiplatelet therapy. Direct as well as network meta-analyses comparing these arms were performed. Risk Differences (RD) with confidence intervals were calculated. RESULTS: 12 studies with 8471 patients were included. On direct meta-analysis, there was no significant difference noted between DAPT compared to Aspirin (RD 0.001 95% CI - 0.012 to 0.014, p = 0.87), Clopidogrel (RD 0.001 95% CI - 0.009 to 0.010, p = 0.92) or no antiplatelet group (RD 0.007 95% CI - 0.011 to 0.026, p = 0.44). Results were consistent on network meta-analysis and no difference was noted in bleeding rates when comparing DAPT with Aspirin (RD 0.001, 95% CI - 0.007 to 0.01, p = 0.76), Clopidogrel (RD 0.001, 95% CI - 0.01 to 0.011, p = 0.90) and no antiplatelet group (RD 0.002, 95% CI - 0.007 to 0.012, p = 0.62). CONCLUSION: There is no significant difference in bleeding risk between DAPT, single antiplatelet or no antiplatelet therapy on a population level. On an individual level, risk of ischemic events should be weighed against the risk of bleeding based on patient circumstances and risk profile. Our findings offer to provide additional data to make an informed decision between patients and physicians to make clinical decisions by assessing individual risks and benefits for optimal care of complex patients.

Prescribing patterns of SGLT-2 inhibitors for patients with heart failure: A two-center analysis.

Background: Sodium glucose co-transporter 2 inhibitors (SGLT2i) have been proven to reduce the combined risk of cardiovascular death and hospitalizations in patients with heart failure (HF), irrespective of the presence or absence of diabetes. Despite class 1 and class 2A recommendations for their usage in HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF) respectively by the American College of Cardiology, their prescription rate has remained low. Objective: The aim of this study is to analyze SGLT2i prescription patterns at two academic institutions, with the goal of identifying barriers to implementation. Design: A two-center retrospective analysis was conducted on patients ≥18 years old with a diagnosis of heart failure who were admitted to one of two hospital systems between 5/1/21 and 5/31/22. Patients with an eGFR ≥20 mL/min/1.73m2 and BNP ≥ 100 pg/mL were included. Results: SGLT2i was prescribed in only 19 out of 1081 HFpEF patients (1.8 %) and 51 out of 1596 HFrEF patients (3.2 %). A majority of SGLT2i prescriptions for the HFpEF population came from general medicine services (57.9 %) after obtaining approval from a cardiologist, which was required at our institutions. Adverse effects such as hypoglycemia and urinary tract infections were not significantly associated with SGLT2i use. Conclusions: Despite proven benefits of this class of medications as witnessed in large-scale clinical trials, the implementation of this drug class continues to be low.

Impact of Hypertensive Disorders of Pregnancy on Stillbirth and Other Perinatal Outcomes: A Multi-Center Retrospective Study.

OBJECTIVE: The aim of the study is to assess the impact of hypertensive disorders of pregnancy on stillbirths and other perinatal outcomes among women in Karachi, Pakistan. METHODOLOGY: This was a retrospective cohort study conducted at two tertiary care hospitals, Aga Khan Hospital (AKU) and Liaquat National Hospital (LNH) in Karachi, Pakistan. The primary outcome variable of this study was stillbirth. Other outcomes assessed in this study included preterm birth, low birth weight, and early neonatal death. RESULTS: Data of a total of 840 women were included in this study; 280 (33.33%) women had hypertensive disorders of pregnancy and 560 (66.67%) were normotensive. Among women who had hypertensive disorders of pregnancy, the adjusted odds ratio (AOR) of having a stillbirth was two times more than that for normotensive women (AOR=2.62, 95% CI=1.46-4.40), four times for low birth weight (AOR=4.23, 95% CI=2.88-6.20), five times for early neonatal death (AOR=5.03, 95% CI=2.40-10.50) and six times for pre-term birth (AOR=5.16, 95% CI=3.42-7.79). CONCLUSION: The current study found that incidence of stillbirth, low birth weight, pre-term birth, and neonatal mortality is higher in mothers with hypertensive disorders of pregnancy than normotensive mothers.

Incidence, prevalence and mortality of chronic periaortitis: a population-based study.

OBJECTIVES: To evaluate the epidemiology, presentation and outcomes of patients with chronic periaortitis from 1998 through 2018. METHODS: An inception cohort of patients with incident chronic periaortitis from January 1, 1998 through December 31, 2018, in Olmsted County, Minnesota was identified based on comprehensive individual medical record review utilising the Rochester Epidemiology Project medical record linkage system. Inclusion required radiographic and/or histologic confirmation of periarterial soft tissue thickening around at least part of the infra-renal abdominal aorta or the common iliac arteries. Data were collected on demographic characteristics, clinical presentation, renal and radiographic outcomes, and mortality. Incidence rates were age and sex adjusted to the 2010 United States white population. RESULTS: Eleven incident cases of chronic periaortitis were identified during the study period. Average age at diagnosis was 61.8±13.4 years. The cohort included 9 men (82%) and 2 women (18%). Age- and sex-adjusted incidence rates per 100,000 population were 0.26 for females, 1.56 for males and 0.87 overall. Overall prevalence on January 1, 2015 was 8.98 per 100,000 population. Median (IQR) length of follow-up was 10.1 (2.5, 13.8) years. Overall mortality was similar to the expected age, sex, and calendar estimates of the Minnesota population with standardised mortality ratio (95% CI) for the entire cohort 2.07 (0.67, 4.84). CONCLUSIONS: This study reports the first epidemiologic data on chronic periaortitis in the United States. In this cohort of patients with chronic periaortitis, men were 4 times more commonly affected than women. Mortality was not increased compared to the general population.

Hyponatremia and Its Correlation With Hepatic Encephalopathy and Severity of Liver Disease.

Background and objective Hepatic cirrhosis is one of the leading causes of morbidity and mortality worldwide. Patients with cirrhosis frequently develop complications such as ascites, variceal bleeding, and hepatic encephalopathy (HE). The clinical manifestations of HE range from the mildly altered level of sensorium to severely altered consciousness levels, difficulty in judgment, the day-night reversal of sleep, flapping tremor of hands, and irrelevant talking or speech. Patients with hyponatremia are at a higher risk of developing HE and electroencephalographic abnormalities. The severity of hyponatremia is directly related to the deterioration in terms of grades of HE. Our study sought to determine the frequency of hyponatremia in cirrhotic patients and its correlation with the frequency and severity of HE. Methodology This study was carried out at the inpatient department of medicine in a tertiary care hospital in Pakistan. A total of 260 patients of both genders with hepatic cirrhosis were approached. After taking relevant history and physical examination, the venous blood sample of each patient was drawn and sent to the institutional laboratory for estimation of serum electrolytes, liver function tests (LFTs), renal parameters (RPMs), prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR). We classified the HE according to the West Haven classification system. Mild to moderate encephalopathy was classified under grades I-II, while severe encephalopathy was classified under grades III-IV. We documented the severity of liver disease according to the Child-Pugh score criteria. All data were analyzed by using SPSS Statistics version 25.0 (IBM, Armonk, NY). We reported the data as means along with the standard error. Results Overall, the serum sodium levels of the subjects ranged from 115 to 142 meq/L with a mean of 129.11 ±6.53 meq/L. In patients with hyponatremia, it ranged from 115 to 127 meq/L (mean 121.41 ±5.17 meq/L). Hyponatremia was present in 96 (36.9%) patients. Among these, 51 (53.12%) were male and 45 (46.8%) were female; 24 (9.2%) patients had mild hyponatremia, 56 (21.5%) had moderate, and 16 (6.2%) had severe hyponatremia. HE was present in 176 (67.7%) patients. HE grade I was present in 54 (20.8%), grade II in 62 (23.8%), grade III in 32 (12.3%), and grade IV in 28 (10.8%) patients. In 96 patients with hyponatremia, 84 were found to have HE (p-value: <0.001). Conclusion Based on our findings, cirrhotic patients with chronic hepatitis infections have a variable presence of low sodium levels. Sodium levels of <130 meq/L were associated with higher morbidity and mortality rate. Moreover, patients with lower levels of sodium had higher grades of HE.