(020) PENILE HYALURONIC ACID INJECTIONS USING UROFILL TECHNIQUE: COMPLICATIONS AND THEIR MANAGEMENT
Authors: Suarez-sarmiento Jr. A , Perito P , Lemos C , Tulio Cavalcanti M , Veber G , Mierzwa T , Mauad D , Dinerman B , Brennan M , Calopedos R 
Published: December 2024

Abstract

Introduction
With the exponential rise of male genital cosmetics by non-urologists, the UroFill® technique represents the first evidence-based bastion in the fight for quality and safety. In addition to inadvisable fillers, use of hyaluronic acid (HA) in penile girth enhancement is increasing. Other HA injection techniques have been described with variable patient satisfaction, cosmesis and complication rates. In this study, we specifically interrogated complications of the patented UroFill® technique, the effect on satisfaction and the effectiveness of their management.

Objective
We specifically examined the complications associated with the patented UroFill® technique, their impact on satisfaction, and the effectiveness of their management.

Methods
This is a multi-center, retrospective study of the UroFill® technique and its complications. Data was collected by six UroFill providers – one in the United States, five in Brazil. All urologists underwent systematic training to become “providers” of the UroFill technique and adhered to the protocols. 563 individual, treatment-naïve patients underwent UroFill® between October 2021 and January 2024. Multiple treatment rounds were completed by each individual to achieve their desired result. Data was analyzed using descriptive statistics and frequency analysis. Comparative analysis employed the Student's t-test, and satisfaction analysis utilized linear regression. All statistical analyses were performed using R software version 3.6.0. Satisfaction was measured by validated questionnaires.

Results
Among the 563 patients, the median age was 43.85 years in Brazil compared to 50.49 years in the United States (range 22-87 years). The median number of treatment visits was 2.2 in Brazil and 3.8 in the United States, while the average volume of units injected per patient was 12.67 ml in Brazil and 15.81 ml in the United States. Of this cohort, 50% were circumcised (n = 224/563) and 26% had penile implant in-situ (n = 148/563). There was no deviation from the prescribed UroFill® technique. 28 of the 563 patients (5%) suffered localized skin infections. Incidence of infection was not associated with number of units used, nor the number of treatment rounds. All skin infections were successfully treated with doxycycline 100 mg twice daily for seven days, warm compresses and abstinence from sexual activity until the infection resolved. If the superficial infection was associated with a fistulous opening, topical Silvadene cream was used until the tract closed. 22/28 were likely due to post-UroFill® protocol non-compliance (early sexual activity or “man-scaping”). No patient required hospitalization, IV antibiotics, incision and drainage, excision of injected HA or granulomatous lesion occurrence. There were no cases of post-UroFill® infected prostheses or mechanical failure from suspected puncture. There was one case of hematoma that required drainage with 22G in office and transient apixaban cessation. Complication rate was not significantly related to satisfaction scores but a statistically significant association between total units injected and satisfaction (p = 0.042) was found.

Conclusions
While the post-UroFill infection rate was relatively high (5%), these were all superficial, skin infections that resolved with outpatient oral antibiotics and temporary behavior modification. It is likely that infection rate is even lower, accounting for non-adherence to post-procedure protocol. These complications did not appear to impact patient satisfaction. With adherence to UroFill technique, there were no cases of complex infective or inflammatory processes that have been observed in alternative HA injection techniques and other methods of penile girth enhancement.

Disclosure
Any of the authors act as a consultant, employee or shareholder of an industry for: UroFIll, Coloplast, Boston Scientific.