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Trial record 48 of 133578 for:    Change

Effect of Pulse Rate Changes on Clinical Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01164280
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : July 16, 2010
Information provided by:
Maastricht University Medical Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement in voiding diary variables

Secondary Outcome Measures :
  1. Improvement in subjective voiding symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01164280

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Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, P.O. box 5800, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
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Principal Investigator: Philip van Kerrebroeck, M.D., Ph.D. Maastricht University Medical Centre

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Responsible Party: Philip van Kerrebroeck, Maastricht University Medical Center Identifier: NCT01164280    
Other Study ID Numbers: MEC 07-2-083 (5266)
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: July 16, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Retention
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders