Effect of Pulse Rate Changes on Clinical Outcome

Overactive Bladder Syndrome Clinical Trial

Official title:

The Effect of Pulse Rate Changes on Clinical Outcome in Sacral Neuromodulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164280
• Other study ID #: MEC 07-2-083 (5266)
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: July 15, 2010
• Start date: July 2008
• Est. completion date: January 2010

Study information

• Verified date: July 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: the Netherlands: Voedsel en Waren Autoriteit
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Urinary Retention
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive
• Urinary Retention

Intervention

Other:
• Pulse Rate Change
Different pulse rate settings of the implantable neurostimulator

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in voiding diary variables
Secondary	Improvement in subjective voiding symptoms