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Effect of Pulse Rate Changes on Clinical Outcome

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01164280
First received: July 14, 2010
Last updated: July 15, 2010
Last verified: July 2010
History of Changes

July 14, 2010
July 15, 2010
July 2008
December 2009   (final data collection date for primary outcome measure)
Improvement in voiding diary variables
Same as current
Complete list of historical versions of study NCT01164280 on ClinicalTrials.gov Archive Site
Improvement in subjective voiding symptoms
Same as current
Not Provided
Not Provided
 
Effect of Pulse Rate Changes on Clinical Outcome
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
  • Overactive Bladder Syndrome
  • Chronic Urinary Retention
Other: Pulse Rate Change
Different pulse rate settings of the implantable neurostimulator
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.
Intervention: Other: Pulse Rate Change
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01164280
MEC 07-2-083 (5266)
No
Philip van Kerrebroeck, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Philip van Kerrebroeck, M.D., Ph.D. Maastricht University Medical Centre
Maastricht University Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP