Overactive Bladder Syndrome Clinical Trial
Official title:
The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation
Objectives: To evaluate the effect of pulse rate changes on the clinical response and
stimulation related pain symptoms in sacral neuromodulation (SNM) treatment.
Materials and Methods: This pilot study evaluated the effect of 4 different pulse rates
(5.2Hz-10Hz-21Hz-40Hz) in patients with suboptimal response to SNM. The effect of each
frequency was evaluated over test period of 6 days. To avoid carry over effect, stimulation
was kept off for 24 hours between consecutive test periods. The last 3 days of every test
period, a voiding diary (VD) and questionnaire was filled in. The changes on clinical
response and pain symptoms were compared between the four pulse-rates using multivariate
analysis.
Results: Fifty patients were included of which 40 (80%) were female. Mean age was 55.5yr (SD
12.3). Forty-one patients (82%) had overactive bladder symptoms and 9 (18%) had chronic
non-obstructive urinary retention. No significant difference was found regarding clinical
outcome (VD and questionnaire) between the different pulse rates. Furthermore, none of the
four pulse rates was significantly related to the occurrence of SNM-related pain. However,
on individual basis, patients appear to benefit from changing the pulse rate concerning both
treatment efficacy and stimulation related pain.
Conclusions: On group level, none of the four pulse rates in this study appears to have a
significantly different effect on clinical outcome or SNM-related pain. However, a
tailor-made approach for optimizing treatment efficacy by changing the pulse rate might be
useful.
n/a
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
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