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Aims of study
Unilateral sacral nerve stimulation (SNS) is effective in treating chronic refractory
voiding dysfunctions as urgency/frequency, urge-incontinence, urinary retention.
Studies suggest improved effectiveness of bilateral stimulation (1,2). A percutaneous
nerve evaluation (PNE) is performed to test if a patient is a candidate for
chronic implantation. This prospective pilot study investigated the feasibility
of comparing unilateral versus bilateral SNS by means of temporary percutaneous
sacral nerve evaluation.
Methods
Seven female patients with urge-incontinence (1), complete urinary retention
(5) and incomplete voiding with residue (1) all refractory to conservative treatment,
were randomised in a 2 arms cross-over design after a bilateral PNE procedure.
Unilateral and bilateral stimulation during at least 72 hours was performed.
Between stimulation periods, a two-day wash-out period was scheduled. Voiding
diaries were filled in at baseline and during the entire evaluation period.
In addition, subjective improvement was scored using a urologic questionnaire.
Sacral X-rays were taken to confirm lead positioning or migration after PNE
and at the end of the stimulation period. After ten days the leads were removed.
Results
Lead migration occurred in 3 patients, leaving analysable data of 4 patients
with complete urinary retention. Mean age was 45,5 (range 27-61). Three patients
started to void with SNS, and 2 of them with a residue of < 100 ml. Baseline
vs unilateral = p = 0.055, unilateral vs bilateral, p = 0.717, baseline vs bilateral
, p =0.043.
|
Mean values (range) |
Voided volume/void
(ml) |
Voided volume/24 hrs (ml) |
Max voided
volume ml) |
Cath volume/void
(ml) |
Cath volume/24
hrs (ml) |
Max cath
volume (ml) |
|
Baseline |
5 (0-21) |
8 (0-32) |
10 (0-40) |
379 (295-498) |
1888 (1555-2164) |
628 (435-1075) |
|
Unilateral |
95 (0-215) |
616 (0-1607) |
178 (0-310) |
210 (3-381) |
896 (25-896) |
314 (10-550) |
|
Bi lateral |
148 (0-245) |
789 (0-1904) |
220 (0-400) |
162 (8-350) |
707 (52-1339) |
328 (30-600) |
Conclusions
During the temporary nerve evaluation period, the effect of SNS mainly depends
on correct positioning of the electrode. Lead migration occurred in 3 out of
7 patients. Results suggest additional but not significant effect of bilateral
stimulation in the subgroup of patients with urinary retention. Currently, this
study with the actual design is continued with a larger number of patients to
test this hypothesis, and will be reported upon during the conference. (1) Bilateral
chronic sacral neuromodulation for treatment of lower urinary tract dysfunction.
J-Urol. 1998 Sep; 160(3 Pt 1): 821-4 (2)Neurophysiologische Grundlagen und klinische
Anwendung der sakralen Neuromodulation zur therapie von Blasenfunctionsstörungen.
Habilitationsschrift. Wuppertal 1997

We prefer a poster-presentation Our study is supported by a generous grant from Medtronic