What is the fate of patients with a neuromodulation implant who embarked on a clinical study?

Background: : To evaluate the long term follow up in terms of safety and usability of the Urgent-SQ system (implantable tibial nerve stimulator) in patients without strict study regime and absence of follow up by the sponsor. Materials & Methods: : Between 2002 and 2004 eight patients were implanted with the Urgent-SQ system. Seven patients were included in previous follow up studies. One patient had loss of efficacy before 1 year of follow up. During this study, all patients who were included in the previous follow-up studies (n=7) were contacted to be interviewed regarding efficacy, usability and safety. Results: : Five out of seven patients were available for assessment, mean age was 72 years (range 65–82).Two patients were considered lost to follow up. None of the interviewed patients reported safety issues, new adverse events or local discomfort. One of the patients was able to visit the hospital for efficacy. However, treatment could not be performed due to deficiency of the external or internal component. All patients did not perform self-stimulation anymore due to external stimulator deficiency (n=2) or loss of effect (n=3). Conclusion: : 18 year follow up of the Urgent-SQ implant demonstrates a high safety profile. However, efficacy after 18 years is lacking in 60% whereas in 40% the therapy cannot be applied because the external stimulator is deficient. In addition to effectiveness and safety assessment, producers should find a solution for long term continuation of technical support. This will increase the lifespan of the implant and allows the patient to continue the treatment.