Effect of Pulse Rate Changes on Clinical Outcome
Primary Purpose
Overactive Bladder Syndrome, Chronic Urinary Retention
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pulse Rate Change
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility 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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulse Rate Change
Arm Description
Patients are subjected to different pulse rate settings of their neurostimulator. The effect of pulse rate changes on clinical outcome is measured.
Outcomes
Primary Outcome Measures
Improvement in voiding diary variables
Secondary Outcome Measures
Improvement in subjective voiding symptoms
Full Information
NCT ID
NCT01164280
First Posted
July 14, 2010
Last Updated
July 15, 2010
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01164280
Brief Title
Effect of Pulse Rate Changes on Clinical Outcome
Official Title
The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome, Chronic Urinary Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulse Rate Change
Arm Type
Experimental
Arm Description
Patients are subjected to different pulse rate settings of their neurostimulator. The effect of pulse rate changes on clinical outcome is measured.
Intervention Type
Other
Intervention Name(s)
Pulse Rate Change
Intervention Description
Different pulse rate settings of the implantable neurostimulator
Primary Outcome Measure Information:
Title
Improvement in voiding diary variables
Secondary Outcome Measure Information:
Title
Improvement in subjective voiding symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip van Kerrebroeck, M.D., Ph.D.
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
P.O. box 5800, 6202 AZ
Country
Netherlands
12. IPD Sharing Statement
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Effect of Pulse Rate Changes on Clinical Outcome
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