There is insufficient evidence to support the use of extra-urethral (non-circumferential retropubic adjustable compression devices (ProACT Therapy System) for treatment of UI. The ProACT Therapy System (Uromedica, Inc.), an adjustable continence therapy, is a minimally invasive urological device designed to treat persons with SUI. A Horizon Scanning Report of the ProACT by the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIPS, 2006) raised questions about the safety of the device. The report concluded that current available literature on the ProACT system suggested that the device is safe for implantation. However as the studies presented suggest there are recurring safety issues with the device, namely post-operative complications such as the migration of the device and erosion of the urethra or the bladder. Although these complications were able to be corrected through removal and later re-implantation of the device in most cases, this presents an added risk to the patient as a result of the re-implantation procedure. Intra-operatively, implantation of the device is not reported as overly difficult and successful implantation may increase as surgeons familiarize themselves with the procedure. Further studies investigating the long-term (more than 2 years) effects of the ProACT Therapy System are needed to ascertain any long-term advantage of the ProACT Therapy System over other treatment options. Furthermore, randomized controlled trials or comparative studies are needed to compare differences in rates of complications between the ProACT Therapy System and other treatment options. The National Institute for Health and Clinical Excellence (2006) has concluded that current evidence on the safety and efficacy of insertion of extra-urethral (non-circumferential) retropubic adjustable compression devices for SUI does not appear adequate for this procedure to be used without special arrangements for consent and for audit and research