Urology Commons^™

Evaluating Dosimetric Outcomes In A Prostate Rapid Plan Model: A Comparison Of Prostate Treatment Plans With And Without Standardized Planning Structures, Erica Wartman

Masters Projects

Abstract

Knowledge-based planning (KBP) using RapidPlan (RP) has demonstrated the ability to produce high quality radiation therapy treatment plans while reducing time. This study evaluated whether the inclusion of department specific standardized planning structures, including rings and other optimization tools, improves plan quality when using a prostate and lymph node RP model, or if the model alone is sufficient to provide a quality plan without the use of these additional planning structures.

Ten previously treated Prostate+LN patients were replanned using the departmental RP model in Varian Eclipse treatment planning system.1 For each patient, two plans were created, one with standardized …

Evaluating Coplanar And Noncoplanar Treatment Plans For The Varian Halcyon And Varian Truebeam For Intact Prostate Patients., Ashley Coppage

Masters Projects

Prostate cancer is among the most treated malignancies with radiation therapy, where precise dose delivery is critical for tumor control and minimizing toxicity. VMAT is widely adopted due to its efficiency and conformity; however, the choice between coplanar and non-coplanar beam arrangements remains an area of ongoing investigation, especially with newer platforms like Halcyon and TrueBeam. This retrospective dosimetric study compares coplanar and non-coplanar volumetric modulated arc therapy (VMAT) treatment plans for intact prostate cancer patients using the Varian Halcyon and Varian TrueBeam systems. Plans were created using a standardized protocol within Eclipse v16.1, with all Halcyon plans employing coplanar …

Changes In Post-Transplant Serum Testosterone Levels In Men Undergoing Lung Transplantation: A Pilot Study Using The Trinetx Research Network, Austin Thompson, Danly Omil-Lima, Jaime Abraham Perez, Erin Jesse, Mohit Khera, Kenneth Chavin, Nannan Thirumavalavan

Faculty, Staff and Students Publications

Hypogonadism is understudied in men requiring solid organ transplants, particularly among lung transplant recipients. Improvement in serum testosterone levels has been reported in kidney and liver transplantation. Using the TriNetX Research Network, we performed a retrospective cohort study to evaluate the incidence of peri-transplant hypogonadism and the natural course of serum testosterone following successful lung transplantation. Men aged ≥ 18 with a lung transplant and total testosterone drawn within one year pre- and post-transplant were included. Men with receipt of testosterone therapy were excluded. A low testosterone (< 300 ng/dL) and normal testosterone (≥300 ng/dL) cohort was created before employing descriptive and analytic statistics to investigate the incidence of peri-transplant hypogonadism and the change in serum testosterone levels following lung transplantation. In our entire cohort, lung transplantation was not associated with a significant increase in post-transplant serum testosterone (329.86 ± 162.56 ng/dL pre-transplant and 355.13 ± 216.11 ng/dL post-transplant, p = 0.483). The number of men with low testosterone decreased by 9.8% following lung transplantation but was not significant, p = 0.404. In this pilot study, no significant change in the number of hypogonadal men nor serum testosterone levels was observed among men undergoing lung transplantation.

Long-Term Testosterone Pellet Insertion In Women With Low Libido Shows No Evidence Of Erythrocytosis And A Minimal Side Effect Profile, Beatriz S Hernandez, Gal Saffati, Katherine A Lowrey, Amit Reddy, Bridget S Park, Jeffrey J Song, Gabrielle Lyon, Mohit Khera

Faculty, Staff and Students Publications

Background: Testosterone therapy for low libido in women has become increasingly prevalent in recent years. While numerous testosterone formulations exist and have been studied in women, there has been little data assessing the safety and efficacy of subcutaneous testosterone pellet use in this population. The primary objective of this study is to understand the biochemical effects and side effect profile of female patients who underwent testosterone pellet insertion in a clinical practice.

Methods: A retrospective chart review of female patients who underwent testosterone pellet insertion from 2009 to 2022 was undertaken. Women taking 75 and 100 mg testosterone pellets were …

Five-Year Outcomes Of Water Vapor Therapy Versus Doxazosin, Finasteride, And Combination Therapy For Lower Urinary Tract Symptoms Secondary To Benign Prostatic Hyperplasia: Cohort Data From The Medical Therapy Of Prostatic Symptoms (Mtops) Trial, Bronwyn Long, Amandip Cheema, Olivia Copelan, Cara Joyce, Marina Feffer, Kevin T. Mcvary

Biostatistics Collaborative Core: Faculty Publications and Other Works

Objective: To compare 5-year clinical and subjective treatment outcomes of water vapor thermal therapy to MTOPS trial cohorts receiving doxazosin, finasteride, or combination therapy.

Methods: MTOPS subjects who received doxazosin, finasteride, combination therapy, or placebo (ClinicalTrials.gov NCT00021814) were compared to the treatment arm of a randomized controlled trial of thermal therapy using the Rezūm System (NCT01912339). Only MTOPS subjects who met criteria for the Rezūm trial were included (prostate volume 30-80 cc, IPSS ≥ 13). Inverse probability weighting by the propensity score was used to adjust for potential confounding variables. Subjective, objective, and clinical progression outcomes were compared …

Vigorous Physical Activity As A Potential Environmental Risk Factor In Renal Medullary Carcinoma, Daniel D Shapiro, Sagar S Mukhida, Andrew W Hahn, Ayman Isahaku, Schyler M Turner, Jessica P Cheng, Pankaj K Chauhan, Susan S Thomas, Beei Chan, Zita D Lim, Nizar M Tannir, Maria Chang Swartz, Pavlos Msaouel

Faculty, Staff and Student Publications

Purpose: Renal medullary carcinoma (RMC) is a rare but aggressive kidney cancer affecting young individuals with sickle hemoglobinopathies. Prior retrospective case-control and mouse modeling studies suggest a mechanism linking vigorous intensity physical activity to increased RMC risk in individuals with sickle hemoglobinopathies. This study aimed to prospectively investigate the association between vigorous intensity exercise and RMC.

Materials and methods: This study used a validated questionnaire to prospectively assess reported physical activity in a large cohort of patients with RMC compared to the activity of individuals without RMC. Between 2022 and 2024, patients with RMC (N = 39) were prospectively surveyed …

Familial Hypocalciuric Hypercalcemia Across Three Generations: Exploring Coexistent Primary Hyperparathyroidism, Liada Itzel Guerrero Arroyo Md, Anda Raluca Gonciuela Md, Sachin Majumdar Md

Posters

FHH due to CASR R220W variant may present with phenotypic variability, including features classically associated with PHPT. Genetic testing is essential in ambiguous cases to avoid unnecessary surgical interventions.

Quality Over Quantity-Current Challenges Of Robotic Surgery In Poland, Marcin Kubiak, Jacek Doniec, S Vincent Grasso, Andrew Gumbs, Amir Nour Mohammadi, Katarzyna Sędłak, Zuzanna Pelc, Stanisław Góźdź, Wojciech Załuska, Artur Bachta, Paweł Rybojad, Kamil Torres, Timothy M Pawlik, Marek Zawadzki, Andrzej Budzyński, Karol Rawicz-Pruszyński

Rowan-Virtua School of Osteopathic Medicine Departmental Research

Since its introduction in 2010, a dynamic growth of robotic-assisted surgery (RAS) has been observed in Poland. The number of healthcare institutions implementing RAS has tripled in the last 36 months, with 80 surgical robots currently utilized on a national scale. While urological procedures dominate RAS utilization (73%), adoption in gynecology (12.2%) and gastrointestinal surgery (8.5%) is rising, driven by recent National Health Fund reimbursement policies. However, significant fragmentation and alarmingly low numbers of individual RAS procedures were identified: 47.7% of surgeons perform less than 40 cases annually. Parallel to expanding the robotic surgery reimbursement program, several standardized actions are …

Cefdinir Use For Adults With Urinary Tract Infections In The Emergency Department, Emily Vo, Brittanii Prahl, William Barany, Barbara Branneman, Jack Huber

2025 Swedish FISH (Fostering Interdisciplinary Solutions in Healthcare) Conference

No abstract provided.

Artificial Intelligence Use In Medical Education: Best Practices And Future Directions, Rasheed A. M. Thompson, Yash B. Shah, Francisco Aguirre, Courtney Stewart, Costas D. Lallas, Mihir S. Shah

Department of Urology Faculty Papers

PURPOSEOF REVIEW: This review examines the various ways artificial intelligence (AI) has been utilized in medical education (MedEd)and presents ideas that will ethically and effectively leverage AI in enhancing the learning experience of medical trainees.

RECENT FINDINGS: AI has improved accessibility to learning material in a manner that engages the wider population. It has utility as a reference tool and can assist academic writing by generating outlines, summaries and identifying relevant reference articles. As AI is increasingly integrated into MedEd and practice, its regulation should become a priority to prevent drawbacks to the education of trainees. By involving physicians in …

Port Site Metastasis After Robotic Assisted Laparoscopic Radical Prostatectomy: Diagnosis Via Prostate-Specific Membrane Antigen (Psma)-Targeted 18f-Dcfpyl Pet/Ct, Joon Yau Leong, Maria D'Amico, Courtney Capella, Leonard Gomella, Joseph Izes

Department of Urology Faculty Papers

We present a case of port site metastasis (PSM) that was identified in an 82-year-old man with an elevated prostate-specific antigen (PSA) to 3.9 ng/mL, concerning for biochemical recurrence after robotic-assisted radical prostatectomy, adjuvant radiation, and six months of androgen deprivation therapy with an undetectable PSA post-treatment over 10 years ago. A 2.1 cm solitary tracer avid nodule on the right lateral abdominal wall with no other evidence of recurrence or metastatic disease was found on prostate-specific membrane antigen (PSMA)–targeted ¹⁸F-DCFPyL PET/CT scan. The patient underwent local excision of this metastatic lesion, and final pathology revealed metastatic prostatic adenocarcinoma.

Evaluation Of An External Urinary Device Protocol And Practices In Hospitalized Female Patients: A Quality Improvement Project At A Rural Midwestern Hospital, Melissa Leibnitz, Ashley Causa, Susana Lopez

Doctor of Nursing Practice Projects: College of Nursing

Aims and Objectives- 1: Describe and measure current implementation and management practices of the PureWick™. 2: Describe and measure current outcomes in the use of the PureWick™ device including mobility scores, skin breakdown, Braden scores, moisture-associated dermatitis, CAUTIs, PAUTIs, hospital LOS, HAIs and HPIs. 3: Measure the survey results from staff regarding the current PureWick™ practices. 4: Propose recommendations for an improved EB protocol for the PureWick^TM.

Background: Currently, the PureWick^TM device has been utilized by facilities as an alternative to indwelling urinary catheters in an effort to reduce the incidence of CAUTI. Since the introduction …

Real-World Management Of High-Risk Prostate Cancer Post-Radical Prostatectomy: Insights From A Regional Quality Collaborative, Aaron R. Hochberg, Annie H. Ho, Rasheed A. M. Thompson, Matthew B. Buck, Costas D. Lallas, Christine Ibilibor, Jeffrey J. Tomaszewski, Serge Ginzburg, Andres Correa, Robert Uzzo, Marc C. Smaldone, John F. Danella, Thomas J. Guzzo, Daniel J. Lee, Laurence Belkoff, Jeffrey Walker, Jay D. Raman, Roderick K. Clark, Adam Reese, Bruce Jacobs, Thomas Jang, Keith J. Kowalczyk, Meghan Smith, Mihir S. Shah

Department of Urology Faculty Papers

Background/Objectives: Data from clinical trials showing the non-inferiority of early salvage radiotherapy were recently incorporated into societal guideline statements. However, questions remain regarding ideal prostate-specific antigen (PSA) criteria for salvage, and how to apply these findings to pathologic lymph node-positive (pN+) disease. We investigated variance in management of clinically localized prostate cancer found to have high-risk features after radical prostatectomy. Methods: We retrospectively identified patients from May 2015 to January 2024 utilizing a multi-institutional, regional collaborative database. The primary outcome was identifying factors associated with the receipt of adjuvant versus salvage therapy. Factors associated with secondary treatment were assessed via …

A Multi-Modal Intervention To Improve Identification, Management, And Prevention Of Recurrent Urinary Tract Infections In The Urgent Care Clinic, Stephanie Krol

Evidence-Based Practice Project Reports

Nearly 60% of women will suffer from a urinary tract infection (UTI) in their lifetime, with 20- 40% of them suffering from multiple (Anger et al., 2022). The primary purpose of this evidence-based project was to implement a multi-modal intervention to improve identification of women who suffer from recurrent urinary tract infections (rUTIs) and to assist in the prevention and treatment of future UTIs. Additionally, the project aimed to increase the number of referrals to urology for better management of these patients. This project was implemented at an Urgent Care Clinic (UCC) in northwest Indiana. Eligible participants who presented with …

Factors Influencing No Show Rates In Adult Urology Patients, Bruce T. Ndebanje, Ethan Griffin, Evelyn James, Lily C. Wang

Costas T. Lambrew Research Retreat 2025

Our study highlights a strong association between insurance status and no-show rates. Patients with Medicaid or no insurance were significantly more likely to miss appointments (OR 3.25 and 5.99).

Rectal Indomethacin Decreases Post-Ercp Pancreatitis In Elderly Patients Without Increasing The Risk Of Acute Kidney Injury, Do Han Kim Md, Donghyun Ko Md, Jose A. Porres, Wilhelm S. Basegoda Md, Carlos Eilzondo-Alatorre Md, Luis M. Nieto Md, Miguel Salazar Md, Paul T. Kroner Md, Pedro Palacios Argueta Md, Frank J. Lukens Md

Posters

This study examines the association of use of rectal indomethacin with clinical outcomes in elderly patients undergoing ERCP using a large population-based multinational database.

Association Of Perioperative Factors With Lymph Node Positivity In Bladder Cancer Following Radical Cystectomy, Alyssa Laguerta, Kimberly Toumazos, Virgil Kevin Demario, Vaishnavi Patel, Balaji Reddy, Mark Quiring, Evan Jones, Young Son, Ronald Clearie, Thomas Mueller

Rowan-Virtua Research Day

Introduction and objectives: The treatment of bladder carcinoma relies on a multimodal approach, including chemotherapy, radical cystectomy, and lymph node dissection, but clear guidelines for the optimal strategy remain ambiguous. Radical cystectomy is complex, with high morbidity and mortality, yet limited research has focused on its short-term implications for lymph node-positive bladder cancer. This study aims to address these gaps by identifying perioperative factors linked to lymph node positivity and comparing outcomes between lymph node-positive and negative patients.

Methods: We conducted a retrospective analysis of 4382 bladder cancer patients who underwent radical cystectomy, collecting comprehensive clinical and surgical data. Clinical …

Ultrasonographic Appearance Of Suspected Zinner Syndrome, Wen Hao Luo, Jared Garfinkle, Jack Hennen, Robert Martin, Kathleen Deiling

Rowan-Virtua Research Day

Zinner syndrome (ZS) is a rare congenital condition characterized by the triad of unilateral renal agenesis, ipsilateral seminal vesicle cyst, and ipsilateral ejaculatory duct obstruction. ZS is suspected to be caused by the malformation of the mesonephric duct during embryogenesis. The incomplete migration of the ureteric bud results in ipsilateral renal agenesis and ejaculatory duct obstruction. The remaining gonad develops with inadequate seminal fluid drainage, leading to the formation of seminal vesicle cysts. ZS is often asymptomatic, leading to challenges in diagnosis, particularly in adolescents. Symptoms can include pain, dysuria, pollakisuria, perineal pain, epididymitis, and pain after ejaculation. Imaging plays …

Case Report: Pigtail Suprapubic Catheter Placement In A Patient With Acute Urinary Retention And Abdominal Mesh, Clara Keum, Zamran Masih, James Espinosa, Alan Lucerna

Rowan-Virtua Research Day

Acute urinary retention (AUR) is a urological emergency that requires immediate bladder decompression and management of the underlying condition to prevent further complications such as urinary tract infection and renal failure. When standard urethral catheterization is not feasible, a suprapubic catheter can be used to achieve adequate bladder drainage. However, in patients with structural or anatomical challenges, such as the presence of surgical mesh, suprapubic catheter placement can be difficult. This case report presents the successful placement of an 8.5 French pigtail catheter and urinary drainage in an 86-year-old male with abdominal mesh who presented with AUR.

The Repercussions Of Race-Based Egfr On The Morbidity & Mortality Of Black Children With Renal Disease, Angelina Siino

Rowan-Virtua Research Day

This study investigates the implications of race-based adjustments in estimated glomerular filtration rate (eGFR) calculations on the health outcomes of Black children with renal disease. Historically, a race coefficient has been added to eGFR calculations for patients identified as Black, resulting in an artificial inflation of kidney function by approximately 16%. This inflation can delay the classification of chronic kidney disease (CKD), postpone eligibility for essential interventions like preemptive kidney transplantation, and prolong reliance on maintenance dialysis. Through a comprehensive literature review of peer-reviewed U.S. medical journal articles published between 2000 and 2023, this work explores how these clinical delays …

Aquablation Compared With Simple Prostatectomy For Prostate Volumes >80 Grams, Joshua Kuperus, Minhaj Jabeer, Aidan Kennedy, Paul Horning, Greg Palmateer, Bernadette M.M. Zwaans, Jason Hafron, Kenneth M. Peters

Posters

• Benign prostatic hyperplasia (BPH) is the most common benign urological disease in men. 1

• Moderate-to-severe lower urinary tract symptoms (LUTS) from BPH affect 30% of men over 502 and medical treatment often fails for men with moderate-to-severe symptoms, leading them to seek surgical options. 3

• Transurethral resection of the prostate (TURP) remains the gold standard for prostates less than 80 mL; simple prostatectomy (SP) remains the standard for larger prostates.

• Aquablation (Aqua) is a novel BPH procedure that may be used for both small and large prostates from 50 to 150 mL. 4

• Although TURP …

Safety, Efficacy, And Pharmacokinetics Of Oral Testosterone Undecanoate In Males With Hypogonadism, Martin Miner, Christina Wang, Jed Kaminetsky, Mohit Khera, Irwin Goldstein, Culley Carson, Nachiappan Chidambaram, Shelby King, Adrian Dobs

Faculty, Staff and Students Publications

Background: Testosterone deficiency results from insufficient testosterone production. Testosterone therapy may require dose titration to reach eugonadal serum testosterone concentrations.

Objective: The primary objective was the efficacy of oral testosterone undecanoate (TLANDO; Antares Pharma Inc.) in male patients with documented hypogonadism. Secondary objectives included a comparison of oral testosterone undecanoate safety and quality-of-life assessments to 1.62% topical testosterone gel (AndroGel 1.62%; AbbVie).

Materials and methods: In this phase 3 study, 315 patients were randomized 2:1 to oral testosterone undecanoate or 1.62% topical testosterone gel (NCT02081300). Patients received 225 mg oral testosterone undecanoate twice daily, and doses were adjusted …

Interactive Module For Medical Student Education In Type I Renal Tubular Acidosis, Het Patel, Emelie-Jo Nappo, Akshata Naik, Suzan Elsayed

Posters

No abstract provided.

Interactive Module Ror Medical Student Education In Type I Renal Tubular Acidosis, Het Patel, Emelie-Jo Nappo, Akshata Naik, Suzan Elsayed

Posters

No abstract provided.

Race Has No Impact On Prostate Cancer-Specific Mortality, When Comparing Patients With Similar Risk Of Other-Cause Mortality: An Analysis Of A Population-Based Cohort, Shane A. Tinsley, Marco Finati, Alex Stephens, Giuseppe Chiarelli, Giuseppe O. Cirulli, Eric M. Williams, Chase Morrison, Caleb Richard, Keinnan Hares, Akshay Sood, Nicolos Buffi, Giovanni Lughezzani, Carlo Bettocchi, Andrea Salonia, Alberto Briganti, Francesco Montorsi, Giuseppe Carrieri, Craig G. Rogers, Firas Abdollah

Medical Student Research Symposium

Background: Other-cause mortality (OCM) can serve as a surrogate for access-to-care. The authors sought to compare prostate cancer-specific mortality (PCSM) in Black versus White men matched based on their calculated OCM risk.

Methods: The Surveillance, Epidemiology, and End Results (SEER) database was queried for Black and White men diagnosed with prostate cancer between 2004 to 2009, to collect long-term follow-up. A Cox regression was used to calculate the OCM risk using all available covariates. This calculated OCM risk was used to construct a 1:1 propensity score matched (PSM) cohort. Then, a competing-risks multivariable tested the impact of race on PCSM. …

Variation In Treatment Recommendations For Low-Risk Prostate Cancer: A Focus On Active Surveillance Across Physician Specialties, Sinyu Yang B.S., Tiffany Chu B.S., Cathryn Bock Ph.D, Jinping Xu M.D.

Medical Student Research Symposium

Prostate cancer (PC) is the second leading cause of cancer-related death in men globally, with 1 in 8 men in the US diagnosed during their lifetime. For Low-Risk Prostate Cancer (LRPC), management options include Watchful Waiting (WW), Active Surveillance (AS), or curative treatments such as prostatectomy or radiation. While curative treatments can have significant long-term side effects like urinary incontinence and sexual dysfunction, AS is less invasive and preferred due to fewer adverse effects. However, variations in physician training may lead to differing recommendations, potentially causing confusion or frustration for patients consulting multiple specialists. This study investigates whether treatment recommendations—AS, …

Opioid Prescribing Patterns And The Effect Of Chronic Kidney Disease In Pediatric Urology Population: A Retrospective Cohort Analysis., Kristen M. Meier, Darren Ha, Carter Sevick, Eliza D. Blanchette, Megan A. Brockel, Vijaya M. Vemulakonda, Kyle O. Rove

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Significant efforts have been undertaken to decrease opioid prescribing, but there is little research into patient-specific factors presenting as barriers in the pediatric surgical population. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to be a safe and effective alternative to opioids for pain control, however, concerns about their impact on renal function limit their use in patients with chronic kidney disease (CKD). Data is limited on the interplay of CKD on opioid prescribing.

OBJECTIVE: We hypothesized that opioid reduction efforts were successful, but patients with CKD would be more likely to receive an opioid prescription than those without CKD. …

Uterus Didelphys Bicollis Bicolpos —A Case Report, Felix Oindi, Felix Nyagaka

Obstetrics and Gynaecology, East Africa

Uterus didelphys refers to a congenital uterine anomaly that occurs due to failed fusion of the paired Müllerian ducts. It is characterized by two separate noncommunicating uterine horns each with its cervix and fallopian tube. Duplication may be limited to the uterus, cervix or also involve the vagina. Here, we present a case of a 27-year-old primigravida incidentally diagnosed during pregnancy, followed up with cervical cerclage at 13 weeks due to a short cervix and had preterm delivery via cesarean section at 35 weeks. She had a successful pregnancy outcome and an uneventful postnatal course. Uterus didelphys is associated with …

Vpac Receptor Positivity In Comparison With Mp-Mri In The Diagnosis Of Prostate Cancer: A Preliminary Study, Nishant Setya, Shridhar Ghagane, Rajendra Nerli, Ashwin Bokare, Mathew Thakur, Leonard Gomella

Kimmel Cancer Center Faculty Papers

Objective: The study aimed to prospectively evaluate the feasibility of diagnosing PCa using voided urine samples and by targeting the genomic VPAC (vasoactive intestinal peptide and pituitary adenylate cyclase-activating peptide) receptors in comparison with multiparametric magnetic resonance imaging (mp-MRI) in male patients (≥40 years of age) with lower urinary tract symptoms and having a serum PSA of >4 but < 15 ng/ml.

Patients and methods: Male patients attending urological services ≥40 years old, with lower urinary tract symptoms and serum PSA levels of >4 but < 15 ng/ml formed the study group. Voided urine samples were collected to target VPAC receptors on malignant cells. All patients underwent mp-MRI. A 12-core transrectal ultrasound-guided prostate biopsy was performed in all, and the results were compared for the diagnosis of PCa.

Results: A total of 61 patients with a median age of 65.33 ± 8.11 years and with a …

Video Discharge Instructions Increase Patient Understanding For Office-Based Procedures: A Randomized Controlled Study, Jenna Bates Maffei, Jeffrey J Song, Gal Saffati, Mohit Khera

Faculty, Staff and Students Publications

Background: Health literacy significantly influences healthcare outcomes, with poor literacy leading to worse quality of life, increased mortality, and higher readmission rates. Recent efforts to improve post-encounter education include structured teach-back methods, patient preference assessments, and standardized discharge instructions. Studies in emergency departments have shown that incorporating video discharge instructions enhances patient understanding and retention of care information. To address the gap in urology, this study aims to evaluate patient comprehension and satisfaction with video discharge instructions following clinic-based vasectomy procedures.

Methods: We performed an Institutional Review Board approved (#H-51614) unblinded randomized controlled study with written consent from each participant. …