At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cycling Versus Continuous Mode in Neuromodulator Programming
In Brief
A clinical study evaluating sacral neuromodulator for Urinary Incontinence, Urge. Completed, enrolled 32 participants across 2 sites.
Detailed Summary
The investigators objective is to compare patient outcomes as changes in validated symptom measures of overactive bladder, the Overactive Bladder Questionnaire Short Form (OABq-SF) symptom scale, between women who are set on cycling versus continuous programs for their neuromodulator. Specifically, the investigators propose to perform a randomized double blind crossover study in women who are successfully treated with neuromodulation to either continuous or cycling mode on the modulator and compare differences between groups on the validated OABq-SF symptom questionnaire. In addition, the investigators will compare differences in urinary frequency and pad counts between women randomized to cycling versus continuous stimulation as measured by a 3 day voiding diary. This investigation will provide evidence-based guidelines for neuromodulator programming.
Study Details
Timeline
Interventions
The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.