Urology Commons^™

Do You Want To Be A Urologist? Gender Differences For Medical Student Perception Of Urology, David Chung, Suvig Dua, Michael Morra, Karim Sidhom, Kunal Jain, Gregory Hosier

Faculty, Staff and Student Publications

INTRODUCTION: Gender inequality has been prevalent in the history of medicine, specifically within surgical specialties. Though there have been advances, urology has remained overwhelmingly male-dominant, with slow growth in female recruitment. This survey study evaluated whether gender-related differences in the perception of urology are present among future applicants that could account for gender disparity seen in recruitment.

METHODS: An anonymized, online survey was distributed to medical students enrolled at the Max Rady College of Medicine during the 2022-2023 semester. Attracting and deterring survey statements were created using current literature to guide topics of interest. Participants rated each statement using a …

Risk Of Secondary Malignancies After Pelvic Radiation: A Population-Based Analysis, Connor Mcpartland, Andrew Salib, Joshua Banks, James R. Mark, Costas D. Lallas, Edouard J. Trabulsi, Leonard G. Gomella, Hannan Goldberg, Benjamin Leiby, Robert Den, Thenappan Chandrasekar

Department of Urology Faculty Papers

Background and objective

Radiation therapy has increasingly been used in the management of pelvic malignancies. However, the use of radiation continues to pose a risk of a secondary malignancy to its recipients. This study investigates the risk of secondary malignancy development following radiation for primary pelvic malignancies.

Methods

A retrospective cohort review of the Surveillance, Epidemiology, and End Results database from 1975 to 2016 was performed. Primary pelvic malignancies were subdivided based on the receipt of radiation, and secondary malignancies were stratified as pelvic or nonpelvic to investigate the local effect of radiation.

Key findings and limitations

A total of …

Ensuring Successful Biomarker Studies In Bladder Preservation Clinical Trials For Non-Muscle Invasive Bladder Cancer, David J. Mcconkey, Brian C. Baumann, Stephanie Cooper Greenberg, David J. Degraff, Scott E. Delacroix, Jason A. Efstathiou, Jared Foster, Susan Groshen, Edward E. Kadel, Francesca Khani, William Y. Kim, Seth P. Lerner, Trevor Levin, Joseph C. Liao, Matthew I. Milowsky, Joshua J. Meeks, David T. Miyamoto, Kent W. Mouw, Eugene J. Pietzak, David B. Solit, Debasish Sundi, Abdul Tawab-Amiri, Pamela J. West, Sara E. Wobker, Alexander W. Wyatt, Andrea B. Apolo, Peter C. Black

School of Medicine Faculty Publications

Recent technological advances have created new opportunities for performing biomarker studies within the National Cancer Institute’s (NCI’s) National Clinical Trials Network (NCTN) clinical trials. These new platforms yield more robust measurements when tissue and blood handling is optimized. At the same time, there is a strong interest in banking tissue and derivatives, such as DNA and RNA, for future biomarker studies using novel platforms that may emerge during the intervening time to trial completion. The NCI recently hosted a Clinical Trials Planning Meeting focused on two trial concepts for bladder preservation in patients with high-risk non-muscle invasive bladder cancer (NMIBC) …

Target: A Randomized, Noninferiority Trial Of A Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling For Prostate Cancer Germline Testing, Stacy Loeb, Scott Keith, Heather Cheng, Amy Leader, Laura Gross, Tatiana Sanchez Nolasco, Nataliya Byrne, Rebecca Hartman, Lauren Brown, Christopher Pieczonka, Leonard Gomella, William Kevin Kelly, Costas Lallas, Nathan Handley, Patrick Mille, James Mark, Gordon Brown, Sameer Chopra, Alexandra Mcclellan, David Wise, Lucas Hollifield, Veda Giri

Department of Urology Faculty Papers

PURPOSE: Germline genetic testing (GT) is important for prostate cancer (PCA) management, clinical trial eligibility, and hereditary cancer risk. However, GT is underutilized and there is a shortage of genetic counselors. To address these gaps, a patient-driven, pretest genetic education webtool was designed and studied compared with traditional genetic counseling (GC) to inform strategies for expanding access to genetic services.

METHODS: Technology-enhanced acceleration of germline evaluation for therapy (TARGET) was a multicenter, noninferiority, randomized trial (ClinicalTrials.gov identifier: NCT04447703) comparing a nine-module patient-driven genetic education webtool versus pretest GC. Participants completed surveys measuring decisional conflict, satisfaction, and attitudes toward GT at …

Evaluating The Management Trends For Priapism And Assessing The Risk Of Priapism After In-Office Intracavernosal Injections: A Cross-Sectional Analysis, Joon Yau Leong, Zachary J. Prebay, David Ebbott, Michael Li, Paul H. Chung

Department of Urology Faculty Papers

We describe the management trends of patients suffering from any priapism and evaluate the risks of developing priapism after intracavernosal injections (ICI) performed in office. We queried TriNetX for two separate male adult cohorts - those presenting with any priapism based on International Classification of Disease code, N48.3 (priapism) and those who underwent ICI in office based on Current Procedural Terminology code, 54235 (injection of corpora cavernosa with pharmacologic agent[s]). We evaluated treatment options for these patients after any priapism and described demographic risks for developing priapism after ICI performed in office. There were 17,545 priapism encounters and 26,104 usages …

Pessary Use In Urology Clinics, Kathy Z. Lu Bs, Emily Brodowsky Md, Alex Stephens Ms, Samantha Raffee Md, Humphrey Atiemo Md

Medical Student Research Symposium

Introduction: Pessaries are a non-invasive treatment option for patients with pelvic organ prolapse (POP) or stress urinary incontinence (SUI). There is currently limited data regarding pessary usage among urology patients. The aim of this study is to determine the patient characteristics that predict long term pessary usage versus surgical intervention.

Methods: A 10-year retrospective review of pessary usage in women with either SUI or POP was performed. Patients were stratified into pessary longevity of less than or greater than one year. Quality of life measures before and after pessary use included pads per day, incontinence symptom index (ISI) scores, and …

Amniotic Bladder Therapy In Patients With Interstitial Cystitis/Bladder Pain Syndrome, Jack Considine, Codrut Radoiu, Sophie Wittenberg, Nivedita Dhar Md, Raghav Madan Md, Jack Vernocke Md, Aron Liaw Md, Alaa Hamada Md

Medical Student Research Symposium

Introduction and Objectives: Our study hypothesis postulates that if patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) bladders exhibit increased inflammation, fibrosis, and urothelial dysfunction, then treatment modalities that modulate inflammation and fibrosis, while promoting a regeneration may have a therapeutic effect in such patients. Amniotic membrane (AM) has been shown to foster a regenerative wound-healing environment. This study investigates the safety and efficacy of bladder injections of AM in patients with treatment resistant IC/BPS.

Methods: Fifteen consecutive treatment resistant IC/BPS patients (mean age 50.7 ± 14.4 years) with a median disease duration of 7 years (5-12 years) were …

Exploring The Effects Of Amniotic Bladder Therapy On Female Sexual Dysfunction In Interstitial Cystitis/Bladder Pain Syndrome Patients, Jonathan D. Lutchka, Jack Vercnocke Md, David Pearlman Md, Aron Liaw Md, Nivedita Dhar Md

Medical Student Research Symposium

Introduction and Objectives: Female sexual dysfunction (FSD) is commonly associated with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). FSD manifests as abnormalities in sexual desire, arousal, orgasm, pain, distress, and satisfaction. Our primary objective was to assess the impact of micronized amniotic membrane injections (AM) on FSD and lower urinary tract symptoms using comprehensive measures, including the multi-domain Female Sexual Function Index (FSFI), the Pain Visual Analog Scale (VAS), and the Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI).

Methods: Study participants included patients diagnosed with IC/BPS and FSD refractory to traditional therapies. Under general anesthesia, these …

Hif Expression In Clear-Cell Renal Cell Carcinoma (Ccrcc) Tumors Of Adults With And Without Obstructive Sleep Apnea (Osa), Olivia Heppell, Carlos Guerra Londono, Nilesh Gupta

Medical Student Research Symposium

Introduction: Upregulation of hypoxia-inducible factors (HIF) is an important pathological feature shared by clear cell renal cell carcinoma (ccRCC) and obstructive sleep apnea (OSA). However, it is unclear whether OSA alters the pathogenesis of ccRCC via HIF expression.

Methods: A retrospective cohort of adults undergoing nephrectomy for ccRCC was identified electronically (IRB#16040-1). The diagnosis of OSA was established with preoperative STOP-BANG scores or polysomnography. A consecutive sample of 20 individuals with and 20 without OSA was selected. Clinical characteristics and pathology results were reviewed. Resected tumor sections were immunohistochemically stained for HIF-1& HIF-2 at antibody dilutions of 1:150. Intensity and …

Clinical Pathway Using Arabic Written Medical Information To Improve Incontinence Healthcare Utilization, John F. Knapp, Codrut Radoiu, Emma Ross, Jack Vercnocke Md, Aron Liaw Md, Nivedita Dhar

Medical Student Research Symposium

Introduction and Objective: Metro Detroit holds ~13% of all Arabic speakers in the U.S.A. and 91% of those in Michigan. Evidence supports that patients who do not speak the local language have poor access to healthcare. This study describes our preliminary experience of managing Arabic only speaking women with bothersome stress urinary incontinence (SUI) from May 2022 to October 2023. These women routinely request same-sex interpreters, which is not always possible, leading to a lack of detailed translation. A potential solution is to use Arabic written medical information (AWMI). The purpose of the study was to retrospectively look at the …

The Utility Of Interventional Anesthesia, Kylie Daguio, Kiley Jackson, Samantha Boever, Andrew Chang, James Keane, Leonard B. Goldstein

SOMA Faculty Publications

no abstract

Spectrophotometric Analysis Of Purple Urine Secondary To Methylene Blue And Hydroxocobalamin Co-Administration, Jeremy Hardin, Henrik Galust, Richard Franklin Clark, Binh Ly, Raymond Theodore Suhandynata

Faculty, Staff and Student Publications

BACKGROUND: The development of purple urine after methylene blue (methylthioninium chloride) and hydroxocobalamin co-administration is a rare clinical entity that has not been fully elucidated. A 47-year-old male presented to the emergency department with hypotension, cyanosis, and depressed mental status. The patient was noted to have profound peripheral and central cyanosis, as well as chocolate-colored arterial blood. He was treated with both methylene blue and hydroxocobalamin and developed purple urine for approximately 1 week.

METHODS: Color chromatography was performed by placing the patient's urine directly onto absorbent filter paper. Urine spectrophotometry was performed utilizing the NanoDrop One/One C UV-Vis Spectrophotometer. …

Validation Of Distinct Bladder Pain Phenotypes Utilizing The Mapp Research Network Cohort, Oluwarotimi Sewedo Nettey, Cindy Gu, Nicholas James Jackson, A Lenore Ackerman

Faculty, Staff and Students Publications

Introduction and hypothesis: As interstitial cystitis/bladder pain syndrome (IC/BPS) likely represents multiple pathophysiologies, we sought to validate three clinical phenotypes of IC/BPS patients in a large, multi-center cohort using unsupervised machine learning (ML) analysis.

Methods: Using the female Genitourinary Pain Index and O'Leary-Sant Indices, k-means unsupervised clustering was utilized to define symptomatic phenotypes in 130 premenopausal IC/BPS participants recruited through the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) research network. Patient-reported symptoms were directly compared between MAPP ML-derived phenotypic clusters to previously defined phenotypes from a single center (SC) cohort.

Results: Unsupervised ML categorized IC/BPS participants into …

Evaluation Of Outcomes Between The Top-Down Versus The Bottom-Up Approach For Retropubic Midurethral Sling, Vidushri Mehrotra, John Pearl, David Sheyn, Susan D. Wherley

Student Scholarship

Introduction and hypothesis: Retropubic midurethral sling (MUS) placement is the gold standard for the treatment of stress urinary incontinence in the USA. The procedure can be approached from either a top-down or a bottom-up direction, but there is a paucity of contemporary data regarding outcomes between these approaches. The aim of this study was to provide updated clinical outcomes data. Methods: This was a retrospective cohort study of women undergoing the retropubic MUS procedure alone or at the time of pelvic organ prolapse repair between 2010 and 2020 at a single academic medical center. The electronic medical record was used …

Comparison Of Thulium Fiber Laser Versus Holmium Laser In Ureteroscopic Lithotripsy: A Meta-Analysis And Systematic Review, Xiaoyu Tang, Shaojie Wu, Zhilong Li, Du Wang, Cheng Lei, Tongzu Liu, Xinghuan Wang, Sheng Li

Faculty, Staff and Student Publications

OBJECTIVES: To compare the efficacy and safety of thulium fiber laser (TFL) to holmium: YAG (Ho: YAG) laser in ureteroscopic lithotripsy for urolithiasis.

METHODS: PubMed, Web of Science, Embase, CENTRAL, SinoMed, CNKI database, VIP and Wanfang Database were systematically searched for all relevant clinical trials until September 2023. References were explored to identify the relevant articles. Meta-analysis was carried out for the retrieved studies using RevMan5.4.1 software, and the risk ratio, mean difference and 95% confidence interval were expressed. Statistical significance was set at p < 0.05. The main outcomes of this meta-analysis were stone-free rate (SFR), perioperative outcomes and intraoperative or postoperative complications.

RESULTS: Thirteen studies, including 1394 patients, were included. According to the results of pooled analysis, …

The Il6/Jak/Stat3 Signaling Axis Is A Therapeutic Vulnerability In Smarcb1-Deficient Bladder Cancer, Chandra Sekhar Amara, Karthik Reddy Kami Reddy, Yang Yuntao, Yuen San Chan, Danthasinghe Waduge Badrajee Piyarathna, Lacey Elizabeth Dobrolecki, David J H Shih, Zhongcheng Shi, Jun Xu, Shixia Huang, Matthew J Ellis, Andrea B Apolo, Leomar Y Ballester, Jianjun Gao, Donna E Hansel, Yair Lotan, H Courtney Hodges, Seth P Lerner, Chad J Creighton, Arun Sreekumar, W Jim Zheng, Pavlos Msaouel, Shyam M Kavuri, Nagireddy Putluri

Faculty, Staff and Student Publications

SMARCB1 loss has long been observed in many solid tumors. However, there is a need to elucidate targetable pathways driving growth and metastasis in SMARCB1-deficient tumors. Here, we demonstrate that SMARCB1 deficiency, defined as genomic SMARCB1 copy number loss associated with reduced mRNA, drives disease progression in patients with bladder cancer by engaging STAT3. SMARCB1 loss increases the chromatin accessibility of the STAT3 locus in vitro. Orthotopically implanted SMARCB1 knockout (KO) cell lines exhibit increased tumor growth and metastasis. SMARCB1-deficient tumors show an increased IL6/JAK/STAT3 signaling axis in in vivo models and patients. Furthermore, a pSTAT3 selective inhibitor, TTI-101, reduces …

Advancing Virtual At-Home Care For Community Health Center Patients Using Patient Self-Care Tools, Technology, And Education [Letter], Cheryl Modica, Joy H. Lewis, Curtis Bay

SOMA Faculty Publications

Abstract

Introduction

Health centers are community-based, patient directed primary care providers that offer accessible, high-quality primary care within medically underserved communities. Screening for cancer and managing complex chronic conditions such as diabetes, hypertension, obesity, and depression are vital services for the vulnerable populations seen by community health centers. Delivering care for complex chronic conditions and preventive services using virtual models that integrate self-care tools and technology is an important approach to increasing access for hard-to-reach patients served by health centers.

Objective

This study aimed to explore the use of a virtual care model, applied using a systems approach and patient-driven …

Regulation Of Androgen Receptor Stability By The Β1pix/Stub1 Complex, Ahmed Chahdi, Carolina Jorgez, Abhishek Seth

Faculty, Staff and Students Publications

The Androgen Receptor (AR) is essential in the development and differentiation of testes and male genitalia. AR expression is tightly regulated at the translational and posttranslational levels. AR posttranscriptional regulation is a major determinant of AR availability since AR is a direct target of E3 ubiquitin ligase STUB1. Our work indicated that the Rac/Cdc42 guanosine triphosphatase guanine nucleotide exchange factor, β1Pix, enhanced AR levels after AR stimulation in HEK293 and HeLa cells. AR stimulation decreased AR ubiquitination which is accompanied by increased β1Pix binding to AR. Ectopic expression of β1Pix decreased AR ubiquitination in Tm4 and HEK293 cells. We demonstrated …

The Urologist’S Role In Bowel Management Of Adult Spina Bifida: A Narrative Review, Malcolm Sundell, George E. Koch, Melissa Kaufman

School of Medicine Faculty Publications

Background and Objective: Urologists are central to the coordinated care of patients with spina bifida (SB), and efforts to optimize bladder management and protection of the upper tracts are well established. However, the urologist’s role in treating this population often extends to the management of bowel dysfunction which may be less defined. The methods available to the urologist for bowel management range from lifestyle modifications to medical and surgical therapy, with many patients requiring combinations of multiple strategies to combat conflicting symptoms of constipation and fecal incontinence (FI). This narrative review aims to compile a detailed algorithm of management options, …

Potential Causal Association Between Gut Microbiome And Posttraumatic Stress Disorder, Qiang He, Wenjing Wang, Dingkang Xu, Yang Xiong, Chuanyuan Tao, Chao You, Lu Ma, Junpeng Ma, Caroline M. Nievergelt, Adam X. Maihofer, Torsten Klengel, Elizabeth G. Atkinson, Chia Yen Chen, Karmel W. Choi, Jonathan R.I. Coleman, Shareefa Dalvie, Laramie E. Duncan, Mark W. Logue, Allison C. Provost, Andrew Ratanatharathorn, Murray B. Stein, Katy Torres, Allison E. Aiello, Lynn M. Almli, Ananda B. Amstadter, Søren B. Andersen, Ole A. Andreassen, Paul A. Arbisi, Ariane Rung, Et Al

School of Public Health Faculty Publications

Background: The causal effects of gut microbiome and the development of posttraumatic stress disorder (PTSD) are still unknown. This study aimed to clarify their potential causal association using mendelian randomization (MR). Methods: The summary-level statistics for gut microbiome were retrieved from a genome-wide association study (GWAS) of the MiBioGen consortium. As to PTSD, the Freeze 2 datasets were originated from the Psychiatric Genomics Consortium Posttraumatic Stress Disorder Working Group (PGC-PTSD), and the replicated datasets were obtained from FinnGen consortium. Single nucleotide polymorphisms meeting MR assumptions were selected as instrumental variables. The inverse variance weighting (IVW) method was employed as the …

Evaluating Noninvasive Brain Stimulation To Treat Overactive Bladder In Individuals With Multiple Sclerosis: A Randomized Controlled Trial Protocol, Betsy H Salazar, Kristopher A Hoffman, John A Lincoln, Christof Karmonik, Hamida Rajab, Santosh A Helekar, Rose Khavari

Faculty, Staff and Student Publications

Background

Multiple Sclerosis (MS) is an often debilitating disease affecting the myelin sheath that encompasses neurons. It can be accompanied by a myriad of pathologies and adverse effects such as neurogenic lower urinary tract dysfunction (NLUTD). Current treatment modalities for resolving NLUTD focus mainly on alleviating symptoms while the source of the discomfort emanates from a disruption in brain to bladder neural circuitry. Here, we leverage functional magnetic resonance imaging (fMRI), repetitive transcranial magnetic stimulation (rTMS) protocols and the brains innate neural plasticity to aid in resolving overactive bladder (OAB) symptoms associated with NLUTD.

Methods

By employing an advanced neuro-navigation …

High Expression Of Trop2 Is Associated With Aggressive Localized Prostate Cancer And Is A Candidate Urinary Biomarker, Shiqin Liu, Sarah J Hawley, Christian A Kunder, En-Chi Hsu, Michelle Shen, Lennart Westphalen, Heidi Auman, Lisa F Newcomb, Daniel W Lin, Peter S Nelson, Ziding Feng, Maria S Tretiakova, Lawrence D True, Funda Vakar-Lopez, Peter R Carroll, Jeffry Simko, Martin E Gleave, Dean A Troyer, Jesse K Mckenney, James D Brooks, Michael A Liss, Tanya Stoyanova

Faculty, Staff and Student Publications

Distinguishing indolent from clinically significant localized prostate cancer is a major clinical challenge and influences clinical decision-making between treatment and active surveillance. The development of novel predictive biomarkers will help with risk stratification, and clinical decision-making, leading to a decrease in over or under-treatment of patients with prostate cancer. Here, we report that Trop2 is a prognostic tissue biomarker for clinically significant prostate cancer by utilizing the Canary Prostate Cancer Tissue Microarray (CPCTA) cohort composed of over 1100 patients from a multi-institutional study. We demonstrate that elevated Trop2 expression is correlated with worse clinical features including Gleason score, age, and …

Impact Of Opioid-Free Analgesia On Pain Severity And Patient Satisfaction After Discharge From Surgery: Multispecialty, Prospective Cohort Study In 25 Countries, Tabish Chawla, Aliya Aziz, Anoosha Marium, Ayesha Akbar Waheed, Faiqa Binte Aamir, Faiza Qureshi, Hammad Ather, Iqra Fatima Munawar Ali, Izza Tahir, Maha Ghulam Akbar, Ronika Devi Ukrani, Sajjan Raja, Sehar Salim Virani, Shahryar Noordin, Saif Ur Rehman, Shalni Golani, Syed Roohan Aamir, Syed Musa Mufarrih, Usama Waqar, Maliha Taufiq

Section of General Surgery

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.
Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview …

Implementing The Teach-Back Method On Pessary Utilization In A Urogynecology Clinic, Marissa Eich

Doctor of Nursing Practice (DNP) Practice Innovation Projects

Background: The effectiveness of pessary patient education using the teach-back method and improving nurse confidence and conviction related to pessary use are essential in improving patient outcomes.
/="/">Local Problem: The current limitations in pessary education stem from constraints in nurse availability and workload distribution.
/="/">Methods: The quality improvement initiative involved conducting surveys to evaluate nurse confidence using surveys adapted from the Agency for Healthcare Research and Quality toolkit before the nurse education session, 1 month into the intervention, and at 3 months, when the implementation period ended. These surveys assessed the effectiveness of the teach-back method.
/="/">Intervention: …

Lights And Shadows On Local Recurrence After Renal Surgery: When, Why And How To Manage, Luca Di Gianfrancesco, Alessandro Crestani, Antonio Amodeo, Paolo Corsi, Davide De Marchi, Eugenio Miglioranza, Giuliana Lista, Ferdinando Daniele Vitelli, Francesca Simonetti, Gian Maria Busetto, Ugo Giovanni Falagario, Martina Maggi, Filippo Marino, Giannicola Genovese, Roberto Falabella, Angelo Porreca

Faculty, Staff and Student Publications

Introduction: This review aims to analyze the existing literature on local recurrence (LR) in patients undergoing partial nephrectomy (PN) for renal cell carcinoma, identifying relative risk factors, and exploring optimal clinical management strategies.

Methods: A comprehensive literature search was conducted across bibliographic databases, primarily focusing on LR rates. Secondary outcomes included evaluation of positive surgical margins (PSM), nephrometry scores, pathological stage (T and grading), perioperative outcomes, time-to-LR, overall survival, and cancer-specific survival.

Results: Due to the heterogeneity, a narrative synthesis was performed. LR rates after PN varied in the literature; with PSM emerging as a significant risk factor. Other LR …

Navigating The Challenges Of Initiating Pediatric Device Trials – A Case Study, R Brandon Hunter, Richard C Willson, Balakrishna Haridas, Christine Luk, Kara Toman, Michael J Heffernan, Gwenyth Fischer, Matthew Wettergreen, Chester J Koh

Faculty, Staff and Students Publications

INTRODUCTION: Pediatric medical devices lag behind adult devices due to economic barriers, smaller patient populations, changing anatomy and physiology of patients, regulatory hurdles, and especially difficulties in executing clinical trials. We investigated the requirements, challenges, associated timeline, and costs of conducting a multi-site pivotal clinical trial for a Class II pediatric physiologic monitoring device.

METHODS: This case study focused on the negotiation of clinical trial agreements (CTAs), budgets, and Institutional Review Board (IRB) processing times for a pediatric device trial. We identified key factors contributing to delays in clinical trial execution and potential best practices to expedite the process while …