BERKELEY, CA (UroToday.com) - The results of one of the earliest and largest prospective, multicenter clinical trials of sacral neuromodulation (SNM) therapy was recently reported after the conclusion of the trial with 5 year follow-up data. Van Kerrebroeck and colleagues from throughout Europe and North America evaluated the long-term safety and efficacy of sacral neuromodulation in 3 groups of patients. Ninety-six patients were treated for urge-incontinence, 25 with urgency frequency, and 31 with urinary retention. Eighty-seven per cent of the 163 patients were female and 152 underwent InterstimR implantation following test stimulation. The overall 5 year results show a moderately effective treatment but in the vast majority of cases, not a “cure-all” for voiding dysfunction. For patients with urge incontinence, mean leaking episodes per day decreased from 9.6 + 6.0 to 3.9 + 4.0 at 5 years. Urgency frequency patients noted decreases in voids per day from 19.3 + 7.0 to 14.8 + 7.6 at 5 years with increases in voided volumes of about 70cc on average. Those in retention were able to cut back on intermittent catheterization frequency from 5 times daily to twice daily. At five years only 16 devices were explanted because of complications or lack of efficacy. Of the 152 patients implanted, 39.5% had an adverse event requiring surgical intervention. The study shows a high correlation between 1 and 5 year success rates for treated patients. There is still room for improving outcomes and hopefully a less expensive, more efficacious device can be developed using this expanding technology. For the time being it appears that SNM is a useful, safe long-term therapy for properly selected patients with realistic expectations. van Kerrebroeck PEV, van Voskuilen AC, Heesakkers JPFA, á Nijholt AABL, Siegel S, Jonas U, Fowler CJ, Fall M, Gajewski JB, Hassouna MM, Cappellano F, Elhilali MM, Milam DF, Das AF, Dijkema HE, van den Hombergh U

J of Urol. 178(5):2029-2034, November 2007
doi:10.1016/j.juro.2007.07.032

PubMed Abstract
PMID: 17869298

UroToday.com Painful Bladder Syndrome Section

Written by Christopher P. Evans, MD, a Contributing Editor with UroToday.

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