Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2008-07-31
2010-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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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.
Pulse Rate Change
Different pulse rate settings of the implantable neurostimulator
Interventions
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Pulse Rate Change
Different pulse rate settings of the implantable neurostimulator
Eligibility Criteria
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Inclusion Criteria
* Patients with suboptimal effect of their neurostimulator
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Maastricht University Medical Center
Principal Investigators
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Philip van Kerrebroeck, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre
Locations
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Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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MEC 07-2-083 (5266)
Identifier Type: -
Identifier Source: org_study_id
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