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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
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 14, 2010
Last Updated
July 15, 2010
Sponsor
Maastricht University Medical Center
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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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