Several clinical studies demonstrate that Robotic HIFU has a low risk of side effects, and patients maintain urinary control and sexual function, preserving their quality of life after treatment.(6)
The HIFI Study, for example, comparing HIFU to surgical removal of the prostate demonstrated that:
- Robotic HIFU is comparable (non-inferior) to surgery, meeting the primary endpoint of non-inferiority for Salvage Treatment-free Survival (STFS) after HIFU compared to surgery at 30 months.
- Patients receiving Robotic HIFU had better outcomes with respect to urinary continence and erectile function compared to patients receiving surgical removal of the prostate at 12 months.