New regenerative interventions and treatment targets in sexual medicine: recommendations from the Fifth International Consultation on Sexual Medicine (ICSM 2024)

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Abstract
Objectives: To describe the array of regenerative interventions seeking to reverse the causes and provide curative treatment for male and female sexual dysfunctions that have been studied and are available for purchase within the medical marketplace, including their treatment targets, mechanisms of action, and outcomes data, with particular attention to the context in which they are applied. Methods: A committee of experts conducted a comprehensive, review of the relevant literature, focusing on publications since the topic of novel treatment targets was last addressed by the International Consultation on Sexual Medicine. Results: Since the ICSM 2010, cell- and energy-based regenerative medical interventions have grown in popularity, with their therapeutic promise and availability in the medical marketplace outpacing the conduct of research to support their use as treatments for sexual dysfunction. While clinical trials and the test of time suggest they are generally safe and well-tolerated, the published studies that consider the efficacy of stem cell, platelet rich plasma, electrical stimulation, photobiomodulation, radiofrequency, laser, and shockwave therapies for sexual health problems suffer from significant methodological limitations. The evidence is strongest for low-intensity shockwave treatment of the penis for erectile dysfunction, followed by vaginal CO2 laser treatment for genitourinary syndrome of menopause, but is not sufficiently robust to reach consensus agreement regarding their clinical recommendation at this time. Discussion: Cell- and energy-based regenerative medical treatments have enormous popular appeal, but at present the scientific evidence for their use to treat sexual problems is insufficient to reach a consensus agreement regarding their clinical use. Future studies should not only consider clinical questions of indication, dosage, and efficacy, but also explore the practical bioethics of conducting translational research within the international medical marketplace.

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