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Effect of Pulse Rate Changes on Clinical Outcome

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01164280
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
18
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pulse Rate Change
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
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 :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Improvement in voiding diary variables []

Secondary Outcome Measures

  1. Improvement in subjective voiding symptoms []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01164280
Other Study ID Numbers:
  • MEC 07-2-083 (5266)
First Posted:
Jul 16, 2010
Last Update Posted:
Jul 16, 2010
Last Verified:
Jul 1, 2010
Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Retention

Study Results

No Results Posted as of Jul 16, 2010