Objectives: To evaluate the long-term efficacy of sacral nerve stimulation
for refractory urinary urge incontinence.
Study Design and Methods: Urge incontinent patients qualified for surgical
implantation of a neurostimulator system after trial screening with percuta
neous test stimulation. Surgical implantation of the InteStim System (Medtr
onic Inc., Minneapolis, Minn., USA) was performed in cases where a >50% red
uction in incontinence symptoms was documented during the 3- to 7-day test
stimulation period. The InterStim System consists of an implantable pulse g
enerator, a transforamenally placed quadripolar lead, and an extension that
connects these two devices for unilateral stimulation of the S3 or S4 sacr
al nerve. Efficacy for 96 implanted patients was based on urinary symptom c
hanges as quantified in voiding diaries collected at baseline and annually
after surgical implantation.
Results: As compared to baseline, the group of 96 implanted patients demons
trated significant reductions in urge incontinent symptoms at an average of
30.8 +/- 14.8 (range 12-60) months with respect to the number of urge inco
ntinent episodes per day, severity of leaking, and the number of absorbent
pads/diapers replaced per day due to incontinence (all p<0.0001, respective
ly). Gender, pretreatment variables, and age were not found to be relevant
factors that affected these results. 11 of the 96 patients underwent device
explant due to lack of efficacy, pain or bowel dysfunction. These data wer
e conservatively included in the efficacy results. No permanent injuries as
sociated with the devices or therapy were reported.
Conclusion: Sacral nerve stimulation is an effective treatment for refracto
ry urge incontinence with sustained long-term benefit through an average of
30.8 months. Copyright (C) 2001 S. Karger AG, Basel.