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May 3

Clinical trials simultaneously presented at AUA and published in … – Science X

Testosterone Comments Off on Clinical trials simultaneously presented at AUA and published in … – Science X

Novel research by investigators at the Desai Sethi Urology Institute (DSUI) at the University of Miami Miller School of Medicine was presented at one of the world's most important urology meetings and simultaneously published in one of the highest impact journals in the specialty.

This reflects the quality of research at the DSUI, as this is the first time the Journal of Urology earmarked and simultaneously published American Urological Association (AUA) annual meeting presentations, according to Ranjith Ramasamy, M.D., director of reproductive urology at DSUI.

Two studies, one on a type of short-acting testosterone therapy and another looking at whether platelet-rich plasma (PRP) works to treat erectile dysfunction (ED), were presented during the April 28 to May 1 AUA 2023 meeting in Chicago and published online the day of each presentation in the Journal of Urology.

"These were randomized clinical trials, which offer the best evidence but also are the most challenging and arduous to conduct," Dr. Ramasamy said. "They reflect the primary focus of the DSUI, which is to conduct investigator-initiated clinical trials."

These studies also offer new information for clinicians and patients on common approaches used to treat common conditions, according to Thomas Masterson, M.D., assistant professor of urology.

Traditional treatments for erectile dysfunction focus on pathways that treat ED symptoms without reversing underlying ED causes. The most popular restorative therapies today are shockwave therapy, platelet-rich plasma and stem cell therapy. Restorative therapies have the potential to reverse the underlying pathology of ED.

"All three of these are not FDA approved for ED, and there is not a lot of good research on them," said Dr. Masterson, who was the author of the study.

"While some small studies have shown potential benefits for platelet-rich plasma, popularly called the "P-shot," larger and more rigorous clinical trials are needed to fully evaluate the efficacy and safety of platelet-rich plasma therapy for erectile dysfunction," said Dr. Manuel Molina, a men's health fellow and sub-investigator in the clinical trial.

DSUI investigators are the first to show using PRP was no better than using placebo to treat ED patients.

"This finding may prompt health care providers to reconsider the use of platelet-rich plasma therapy as a viable treatment option for erectile dysfunction until further research provides more conclusive evidence," said Braian Ledesma, a student and study coordinator. Ledesma presented this finding as a late-breaking abstract at the AUA annual meeting.

Patients need to be informed consumers, according to Dr. Masterson.

"This study is the first negative study suggesting PRP, which can be very expensive, may not be any better than a placebo," he said.

There are several forms of testosterone therapy, including those that are injected intramuscularly or subcutaneously, applied to the skin or taken orally as pills, as well as intranasal gel, which is applied on and absorbed into the nasal mucosa.

"Traditional forms of testosterone therapy are known to increase hematocrit, which is the percentage of red blood cells in your blood. That could lead to a risk of cardiovascular events, like heart attacks, blood clots or stroke," said Marco-Jose Rivero, an author on the study and a Miami Andrology Research Scholar at DSUI. "Our objective for this trial was to evaluate and compare intramuscular testosterone therapy versus intranasal testosterone gel, with regards to whether or not they increase hematocrit."

This is the first head-to-head study comparing the two, according to Dr. Ramasamy. Men were randomized to receive either intramuscular testosterone, which is administered every two weeks by injection, or the nasal gel, which is applied two to three times daily.

The researchers found that intramuscular testosterone does increase hematocrit levels, while intranasal testosterone gel does not. And intranasal testosterone gel may be a better option for patients with cardiovascular risk factors and others who want to avoid the potential side effect, according to Rivero.

"This finding is important because we do believe the increased red blood cell count or hematocrit is what puts people at risk of cardiovascular or thrombotic events," said Russell Saltzman, the clinical trial coordinator.

Rivero, a medical student, said that his working on such an impactful randomized clinical trial has allowed him to gain research experience in a rigorous study design, while also further developing his ability to care for patients.

"I am grateful for the opportunity to share my findings with a national audience, through both a poster presentation at the AUA and a publication in the Journal of Urology," Rivero said.

More information:Marco-Jose Rivero et al, Comparison of Hematocrit Change in Testosterone-Deficient Men Treated With Intranasal Testosterone Gel vs Intramuscular Testosterone Cypionate: A Randomized Clinical Trial, Journal of Urology (2023). DOI: 10.1097/JU.0000000000003487

Thomas A. Masterson et al, Platelet-rich Plasma for the Treatment of Erectile Dysfunction: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial, Journal of Urology (2023). DOI: 10.1097/JU.0000000000003481

Provided by University of Miami Health System, Miller School of Medicine

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