Trinity J. Bivalacqua, MD, PhD

Trinity J. Bivalacqua, MD, PhD

Johns Hopkins University

Baltimore, Maryland

Trinity J. Bivalacqua, MD, PhD, is the Director of Urologic Oncology and the R. Christian B. Evensen Associate Professor of Urology and Oncology at the James Buchanan Brady Urological Institute of Johns Hopkins Medicine in Baltimore, Maryland. He also has an active clinical practice. Dr. Bivalacqua received his undergraduate, graduate, and medical degrees from Tulane University in New Orleans. He went on to complete general surgery and urology training at Johns Hopkins Hospital. He also completed an American Urological Association Foundation Post-Doctoral Fellowship. Dr. Bivalacqua has a particular interest in prostate and bladder cancers, and focuses on organ-sparing therapies, minimally-invasive techniques, and orthotopic bladder substitution. He has received several research grants, including a Career Development Award from the National Institute of Health and an AUA “Rising Star” Award. At present, Dr. Bivalacqua’s research lab is largely focused on the development of preclinical models of urothelial carcinoma to test systemic and intravesical immunotherapies and nano-particular based chemotherapies. He is also interested in regenerative approaches to enhance autonomic nerve function and the development of engineered urinary tissue.

Disclosures:

Articles by Trinity J. Bivalacqua, MD, PhD

Biologics in Sexual Medicine – Controversy and Therapeutic Potential

Trinity J. Bivalacqua, MD, PhD, Director of Urologic Oncology and R. Christian B. Evensen Associate Professor of Urology and Oncology at the James Buchanan Brady Urological Institute of Johns Hopkins Medicine in Baltimore, Maryland, discusses studies on biologics and low-intensity extracorporeal shock wave therapy (Li-ESWT), as well as controversial misinformation surrounding their use in sexual medicine. He reviews the results of a Li-ESWT study which displayed the treatment’s ability to improve symptoms, exercise capacity, and myocardial perforation in patients with severe coronary artery disease without indication for percutaneous coronary intervention or coronary artery bypass graft surgery. He then argues that for-profit stem cell clinics who offer biologic treatment for sexual medicine promise results with no supporting efficacy data, and that the trials these clinics use for support are not well-designed. Dr. Bivalacqua concludes that there is a demonstrated therapeutic potential for biologics, but more research is needed to support their use in sexual medicine and to prove their therapeutic value.

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The First Tissue Engineered Neo-Urinary Conduit (NUC) Clinical Trial for Complete Organ Replacement: Successes, Pitfalls, Challenges

Trinity J. Bivalacqua, MD, PhD, Director of Urologic Oncology at Johns Hopkins Medicine, discusses the first tissue-engineered neo-urinary conduit (NUC) clinical trial for complete organ replacement in patients with bladder cancer. He explains that the standard methods of using the genitourinary (GI) tract for cystectomy in patients with bladder cancer often cause sustained and significant complications associated with exposing the GI tissue to urine, and therefore the development of a urinary diversion using autologous cell sources for a tissue-engineered urinary conduit is warranted. Dr. Bivalacqua then details the process by which his team attempted to do this: isolating smooth muscle cells, seeding them on a biodegradable PLGA scaffold, and then implanting the construct after cystectomy, first in porcine subjects and then in human patients during the phase I trial. He notes that while all the NUCs had to be explanted due to stomal stenosis or NUC stricture, his team did successfully regenerate urinary tissue using smooth muscle cells, and he hopes researchers will progress toward the development of a clinically functional urinary conduit in an ongoing multicenter phase I/II trial.

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Evidence-Based Guideline for Management of Priapism: Perspectives from AUA/EAU Guideline Panel

Trinity J. Bivalacqua, MD, PhD, Director of Urologic Oncology at Johns Hopkins Medicine, discusses potential solutions to the issues with bacillus Calmette-Guérin (BCG) as a treatment for high-risk non-muscle invasive bladder cancer (NMIBC). Intravesical BCG is more effective than chemotherapy for NMIBC, but approximately ⅓ of high-risk patients are BCG-unresponsive, and there is also a BCG shortage. Dr. Bivalacqua lists potential solutions to both these problems, including early cystectomy, increasing the availability of BCG by using alternative strains, and enhancing immunotherapy. He concludes by discussing research intended to characterize immune cell expression among patients with NMIBC treated with BCG which found that immune checkpoint inhibition with BCG may be beneficial in a subset of patients who experience tumor recurrence after BCG.

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Adaptive Immune Resistance to Intravesical BCG in NMIBC: Implications for Ongoing and Future BCG Unresponsive Clinical Trials

Trinity J. Bivalacqua, MD, PhD, Director of Urologic Oncology at Johns Hopkins Medicine, discusses potential solutions to the issues with bacillus Calmette-Guérin (BCG) as a treatment for high-risk non-muscle invasive bladder cancer (NMIBC). Intravesical BCG is more effective than chemotherapy for NMIBC, but approximately ⅓ of high-risk patients are BCG-unresponsive, and there is also a BCG shortage. Dr. Bivalacqua lists potential solutions to both these problems, including early cystectomy, increasing the availability of BCG by using alternative strains, and enhancing immunotherapy. He concludes by discussing research intended to characterize immune cell expression among patients with NMIBC treated with BCG which found that immune checkpoint inhibition with BCG may be beneficial in a subset of patients who experience tumor recurrence after BCG.

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Path to the First Penoscrotal Transplant: Pre-Clinical Studies that Led to Penile Allotransplantation

Trinity J. Bivalacqua, MD, PhD, Director of Urologic Oncology at the James Buchanan Brady Urological Institute of Johns Hopkins Medicine, discusses the groundbreaking penoscrotal implant surgery performed by a multidisciplinary team at Johns Hopkins Medicine in 2018. He explains their rationale for performing a procedure that many consider dangerous and unnecessary, saying that patients have a right to be normal and to decide on their own fate, and noting that they discussed the surgery with their patient, a military vet who lost his phallus from a blast injury, for years before operating. Dr. Bivalacqua goes on to summarize the pre-clinical cadaveric and ex vivo studies conducted before the procedure, emphasizing the important developments in increasing transplant tolerance and improvements in vascularizing penile allografts. He concludes by saying that the surgery was successful and thus far the graft has not shown rejection, but he notes that the procedure’s utility in clinical practice remains unknown.

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Associate Editors


Fred Bartlit, Esq.
StrongPath


Mark A. Moyad, MD, MPH
University of Michigan
Ann Arbor, Michigan