Effect of Pulse Rate Changes on Clinical Outcome

NCT01164280 | Completed

• 1 other identifier: MEC 07-2-083 (5266)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder Syndrome; Chronic Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Improvement in voiding diary variables

Secondary Outcomes (1)

• Improvement in subjective voiding symptoms

Study Arms (1)

Pulse Rate Change

EXPERIMENTAL

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

Interventions

Pulse Rate Change OTHER

Different pulse rate settings of the implantable neurostimulator

Pulse Rate Change

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been implanted with a neurostimulator for overactive bladder symptoms or urinary retention
• Patients with suboptimal effect of their neurostimulator

You may not qualify if:

• Patients with 100% effect of their neurostimulator

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, P.O. box 5800, 6202 AZ, Netherlands

Location

Study Officials

• Philip van Kerrebroeck, M.D., Ph.D.

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

NL (1)