Aims: Electrical stimulation of the posterior tibial nerve (PTN) is an established therapy for the treatment of refractory overactive bladder syndrome (OAB). The Urgent-SQ™ is an implant that is surgically placed near the PTN and activated by an external pulse generator, allowing for "on demand" PTN stimulation, without the need for needle insertion. The current study presents results of a 9-year, open-label, follow-up of eight patients to address the long term safety and efficacy of the implant.
Methods: In 2003, eight patients with refractory OAB received a Urgent-SQ™ implant and were systematically followed up for 1 year. After that, the follow up continued as open-label study. The seven patients who still had the implant were contacted after 9 years and evaluated with an interview, physical exam, ankle X-ray, voiding diaries, and completed questionnaires about adverse events, performance, efficacy, safety, and quality of life (validated iQoL).
Results: Six of the seven patients still had sensory and loco-motor responses on stimulation at 9-year follow-up. Three of four patients who had a successful treatment response at 1 year, still use the device. The fourth patient restarted therapy. The implants are intact with no migration and/or displacement. All patients reported easy handling of the Urgent-SQ™. One patient reported sporadic spontaneous sensory responses. One patient reported occasional localized ankle discomfort.
Conclusions: After 9 years of clinical experience, we demonstrated that implant driven PTNS with the Urgent-SQ™ is a safe therapy for OAB. The implant has a long lifespan and is well tolerated by patients.
Copyright © 2012 Wiley Periodicals, Inc.