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
  Purpose

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 Intervention
Overactive Bladder Syndrome
Chronic Urinary Retention
Other: Pulse Rate Change

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Improvement in voiding diary variables

Secondary Outcome Measures:
  • Improvement in subjective voiding symptoms

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01164280

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

No publications provided

Responsible Party: Philip van Kerrebroeck, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01164280     History of Changes
Other Study ID Numbers: MEC 07-2-083 (5266)
Study First Received: July 14, 2010
Last Updated: July 15, 2010
Health Authority: the Netherlands: Voedsel en Waren Autoriteit

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Retention
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders

ClinicalTrials.gov processed this record on September 30, 2014