Effect of Pulse Rate Changes on Clinical Outcome

Not Applicable

Completed

• Conditions: Overactive Bladder Syndrome; Chronic Urinary Retention
• Interventions: Other: Pulse Rate Change

• Registration Number: NCT01164280
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2010-07
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-15
• Last Update Submitted: 2010-07-15
• Study First Posted: 2010-07-16
• Last Update Posted: 2010-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulse Rate Change	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.

Primary Outcome Measures

Name	Time	Method
Improvement in voiding diary variables

Secondary Outcome Measures

Name	Time	Method
Improvement in subjective voiding symptoms

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands