Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study.
OBJECTIVE
This 5-year, prospective, multicenter trial evaluated the long-term safety and efficacy of sacral neuromodulation in patients with refractory urge incontinence, urgency frequency and retention.


METHODS
A total of 17 centers worldwide enrolled 163 patients (87% female). Following test stimulation 11 patients declined implantation and 152 underwent implantation using InterStim. Of those treated with implantation 96 (63.2%) had urge incontinence, 25 (16.4%) had urgency frequency and 31 (20.4%) had retention. Voiding diaries were collected annually for 5 years. Clinical success was defined as 50% or greater improvement from baseline in primary voiding diary variable(s).


RESULTS
Data for all implanted cases were reported. For patients with urge incontinence mean leaking episodes per day decreased from 9.6 +/- 6.0 to 3.9 +/- 4.0 at 5 years. For patients with urgency frequency mean voids per day decreased from 19.3 +/- 7.0 to 14.8 +/- 7.6, and mean volume voided per void increased from 92.3 +/- 52.8 to 165.2 +/- 147.7 ml. For patients with retention the mean volume per catheterization decreased from 379.9 +/- 183.8 to 109.2 +/- 184.3 ml, and the mean number of catheterizations decreased from 5.3 +/- 2.8 to 1.9 +/- 2.8. All changes were statistically significant (p <0.001). No life threatening or irreversible adverse events occurred. In 102 patients 279 device or therapy related adverse events were observed. At 5 years after implantation 68% of patients with urge incontinence, 56% with urgency frequency and 71% with retention had successful outcomes.


CONCLUSIONS
This long-term study demonstrates that InterStim therapy is safe and effective for restoring voiding in appropriately selected cases refractory to other forms of treatment.
van Kerrebroeck
Philip E V
PE
Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands. Pvk@suro.azm.nl
van Voskuilen
Anco C
AC
Heesakkers
John P F A
JP
Lycklama á Nijholt
August A B
AA
Siegel
Steven
S
Jonas
U
U
Fowler
Clare J
CJ
Fall
Magnus
M
Gajewski
Jerzy B
JB
Hassouna
Magdy M
MM
Cappellano
Francesco
F
Elhilali
Mostafa M
MM
Milam
Douglas F
DF
Das
Anurag K
AK
Dijkema
H E
HE
van den Hombergh
Ubi
U
D000328:Adult; D004567:Electrodes, Implanted; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008160:Lumbosacral Plexus / Q000503:physiopathology*; D008297:Male; D011446:Prospective Studies; D013997:Time Factors; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation*; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000294:innervation* / Q000503:physiopathology; D053202:Urinary Incontinence, Urge / Q000503:physiopathology / Q000628:therapy*; D016055:Urinary Retention / Q000503:physiopathology / Q000628:therapy*; D014563:Urodynamics