This document discusses a 9-year follow up study of 8 patients who received an implant called the Urgent-SQ to stimulate the posterior tibial nerve for the treatment of overactive bladder syndrome. The results showed that after 9 years, 6 of the 7 patients who still had the implant demonstrated sensory and motor responses to stimulation. Of the 4 patients who initially responded well to treatment, 3 still use the device successfully while the 4th restarted therapy. The implants were found to be intact with no migration or displacement after 9 years. Patients reported the implant was easy to use with only minor side effects reported. The study demonstrates that implant-driven PTNS with the Urgent-SQ provides long-term safety and efficacy for
8. 5 NOV 2013
PTNS-schema?
PTNS 1 of beide benen?
PTNS-stimulatieparameters?
PTNS-indicaties?
PTNS bij neurogeen blaaslijden?
PTNS bij instabiliteiten?
PTNS en andere behandelingen?
PTNS-toekomst?
10. 5 NOV 2013
PTNS-schema?
PTNS 1 of beide benen?
PTNS-stimulatieparameters?
PTNS-indicaties?
PTNS bij neurogeen blaaslijden?
PTNS bij instabiliteiten?
PTNS en andere behandelingen?
PTNS-toekomst?
12. 5 NOV 2013
PTNS-schema?
PTNS 1 of beide benen?
PTNS-stimulatieparameters?
PTNS-indicaties?
PTNS bij neurogeen blaaslijden?
PTNS bij instabiliteiten?
PTNS en andere behandelingen?
PTNS-toekomst?
14. 5 NOV 2013
PTNS-schema?
PTNS 1 of beide benen?
PTNS-stimulatieparameters?
PTNS-indicaties?
PTNS bij neurogeen blaaslijden?
PTNS bij instabiliteiten?
PTNS en andere behandelingen?
PTNS-toekomst?
16. 5 NOV 2013
PTNS-schema?
PTNS 1 of beide benen?
PTNS-stimulatieparameters?
PTNS-indicaties?
PTNS bij neurogeen blaaslijden?
PTNS bij instabiliteiten?
PTNS en andere behandelingen?
PTNS-toekomst?
19. 5 NOV 2013
PTNS-schema?
PTNS 1 of beide benen?
PTNS-stimulatieparameters?
PTNS-indicaties?
PTNS bij neurogeen blaaslijden?
PTNS bij instabiliteiten?
PTNS en andere behandelingen?
PTNS-toekomst?
20. 5 NOV 2013
Neurourol Urodyn. 2013 Jun;32(5):472-5. doi: 10.1002/nau.22322. Epub 2012 Oct 15.
Urgent-SQ implant in treatment of overactive bladder syndrome: 9-year follow-up study.
Janssen DA, Farag F, Heesakkers JP.Source
Department of Urology, Radboud University, Nijmegen Medical Centre, Geert Grooteplein Zuid, Nijmegen,
The Netherlands. d.janssen@uro.umcn.nl
Abstract
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.