Overactive Bladder Clinical Trial
Official title:
Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study
Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB).
This is a follow-up study of the study by van der Pal et al. (see reference). The Urgent-SQ
is an ankle (tibail) implant that is used for on demand electical stimulation that
stimulates the tibial nerve for the treatment of overactive bladder syndrome (OAB). The
implant is placed via an minimal invasive surgical procedure. The implant can be activated
with an external pulse generator.
This study by van de Pal et al. was conducted with the approval of the local Medical Ethical
Committee and with a one year systematic follow-up of eight patients. Since then, follow-up
up and use of the device was open-label.
This study reports on the long-term (9yrs) the safety and durability of the Urgent-SQ
implant in these eight patients.
Parameters evaluated were local pain and discomford at the site of the implant, AE's related
to the implant or the use of the implant. Current use of the treatment and effectivity of
the treatment.
van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL.Implant-Driven Tibial
Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month
Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.
;
Observational Model: Cohort, Time Perspective: Prospective
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