Medium-Term Outcomes of the VICTO Adjustable Artificial Urinary Sphincter: A Brazilian Real-World Multicentre Study

For many men, the aftermath of prostate cancer treatment brings a difficult and often isolating challenge: the inability to control urine flow. When the muscles that normally hold the bladder closed are damaged during surgery, the result is stress urinary incontinence, where even a slight cough, laugh, or change in position can cause leakage. For decades, the most reliable solution has been the artificial urinary sphincter, a small mechanical device implanted inside the body to act as a substitute for those damaged muscles. This device works like a cuff that squeezes the urethra shut, keeping it closed until the patient manually releases it to urinate. While effective, traditional versions of this device have a significant flaw: once implanted, the pressure of the cuff is fixed. If the pressure is too high, it can damage the delicate urethral tissue; if it is too low, it fails to stop the leakage. Because the pressure cannot be changed without a second surgery, doctors have long sought a way to fine-tune the device after it is already in place.

A new study from Brazil explores a modern version of this device called the VICTO, which offers a solution to that fixed-pressure problem. Unlike older models, the VICTO includes a small port that allows doctors to adjust the pressure through the skin, without cutting the patient open again. This means the device can be dialed up or down to find the perfect balance for each individual's body. To see if this adjustable approach works in real-world practice, researchers at four major hospitals in São Paulo tracked the progress of fifty men who received the implant. They followed these patients for an average of sixteen and a half months, looking at how well the device stopped leaks, how often it caused problems, and how satisfied the men were with the results.

The study found that the adjustable device performed very well, offering a level of success comparable to the long-standing gold standard in the field. By the time of the final check-up, nearly three-quarters of the men had achieved what doctors call "social continence," meaning they used one or fewer absorbent pads per day. About two out of every five men were completely dry, using no pads at all. Almost all of the men who started the study saw a significant improvement, with the vast majority reducing their pad usage by at least half. The ability to adjust the pressure after surgery appeared to be a key factor, as many patients who were not yet fully dry had not yet reached the maximum pressure limit of the device, suggesting that further tweaks could potentially help them achieve even better results.

Safety was another major focus of the research. The device proved to be safe, with no infections reported in this group of patients. However, like any surgical implant, it was not without complications. About one in five men experienced some form of postoperative issue, ranging from minor fluid buildup to more serious problems that required surgery. In six percent of cases, the device had to be completely removed. These removals were necessary for two men who developed erosion, where the device wore through the urethra, and for one man whose pump mechanism failed. Despite these risks, the men who kept the device were largely happy with the outcome. More than three-quarters of the participants rated their satisfaction as high, noting that the ability to control their daily lives without constant worry about leakage was a profound improvement.

The researchers also looked closely at whether certain patient histories made the treatment more likely to fail. They examined factors such as previous radiation therapy, diabetes, or prior surgeries for incontinence, all of which are known to complicate healing. Surprisingly, none of these factors predicted a poor outcome in this specific group. While the study was too small to draw a definitive conclusion about why these risks did not appear to matter, the authors suggest that the adjustable nature of the VICTO might be the reason. Because doctors can lower the pressure if the tissue is fragile or raise it if the leak is severe, the device can be customized to the patient's specific needs, potentially neutralizing risks that would be problematic with a fixed-pressure device.

This study provides the first detailed look at how this adjustable device performs in Latin America, filling a gap in global medical knowledge. The results suggest that the VICTO is a safe and effective tool for men struggling with severe incontinence, offering a level of control and quality of life that matches the best treatments currently available. While the follow-up period was not long enough to see if the device holds up for many years, the medium-term results are encouraging. The findings indicate that the ability to fine-tune the pressure after surgery is a practical advantage that allows doctors to manage difficult cases with greater precision, turning a once rigid solution into a flexible one that adapts to the patient.