Effect of Pulse Rate Changes on Clinical Outcome
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|ClinicalTrials.gov Identifier: NCT01164280|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : July 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome Chronic Urinary Retention||Other: Pulse Rate Change||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
Experimental: Pulse Rate Change
Patients are subjected to different pulse rate settings of their neurostimulator. The effect of pulse rate changes on clinical outcome is measured.
Other: Pulse Rate Change
Different pulse rate settings of the implantable neurostimulator
- Improvement in voiding diary variables
- Improvement in subjective voiding symptoms
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164280
|Maastricht University Medical Centre|
|Maastricht, Limburg, Netherlands, P.O. box 5800, 6202 AZ|
|Principal Investigator:||Philip van Kerrebroeck, M.D., Ph.D.||Maastricht University Medical Centre|