Effect of Pulse Rate Changes on Clinical Outcome

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation

Conditions
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Overactive Bladder Syndrome, Chronic Urinary Retention

Intervention / Treatment
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* Other: Pulse Rate Change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention Patients with suboptimal effect of their neurostimulator Exclusion Criteria: Patients with 100% effect of their neurostimulator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulse Rate Change<br>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<br>* Different pulse rate settings of the implantable neurostimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in voiding diary variables |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in subjective voiding symptoms |  |  |