Clinical Research Directory

Male Intimate Harmonization: Efficacy, Satisfaction, and Safety

Sponsor: Antony Barbosa Institute

Summary

Dissatisfaction with penile size and aesthetics may negatively affect men's self-esteem and quality of life, representing a relevant factor in psychological and sexual health. Intimate aesthetic procedures have increasingly been sought as an alternative to improve body perception and male confidence. Among the available techniques, the use of botulinum toxin and hyaluronic acid-based fillers has demonstrated potential to increase penile circumference and reduce the retraction reflex, providing functional and aesthetic benefits. However, the literature lacks robust studies evaluating the efficacy, safety, and psychological impact of these interventions. The primary objective of this study is to evaluate the efficacy, safety, and level of satisfaction associated with male intimate harmonization methods using botulinum toxin and hyaluronic acid. In addition, the study aims to analyze the effects of these techniques on patients' self-esteem and body perception, particularly in individuals with small penis syndrome or anxiety related to penile size. This is a prospective clinical trial. Participants will be selected according to predefined criteria and will undergo an initial evaluation by a urologist. On the first day, Dysport 300SU botulinum toxin will be administered along the length of the penis, with 60% of the volume concentrated near the base. Patients will use a penile extender for at least four hours per day until the follow-up visit, scheduled 15 days after administration. At this visit, measurements of penile length and circumference will be obtained in both flaccid and erect states, followed by the administration of hyaluronic acid for penile filling. The final evaluation will take place after 30 days for a new measurement of the parameters. The procedures are expected to result in a significant increase in penile size and circumference, as well as improvements in body perception, self-esteem, and sexual satisfaction among participants. Furthermore, this study intends to contribute to the scientific evidence base regarding male intimate aesthetics by providing evidence on the safety and efficacy of the proposed techniques and assisting in the standardization of these interventions in clinical practice.

Official title: Efficacy, Satisfaction, and Safety of Male Intimate Harmonization Methods: A Clinical Trial

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