Neuromodulation Implantation Settings Variation for Overactive Bladder
Withdrawn before enrolling · Not applicable
Conditions studied: Overactive Bladder
In brief
Participants receiving neuromodulation treatment for overactive bladder symptoms will be routinely fitted with an impulse generator. However, the setting on the impulse generator will be set to either intermittent or continuous stimulation. Participants will complete voiding logs and surveys for a month. Battery life will be interrogated.After a one week period were the device is turned off, the impulse generator will be turned to the opposite setting (intermittent or continuous) and the one month period will be repeated. Again, voiding logs, surveys, and battery life will be collected. The purpose of this project is to investigate the outcomes of intermittent versus continuous stimulation in patients treated with sacral neuromodulation (SNM) for refractory overactive bladder (OAB) syndrome. In addition, the potential for an improved battery life with intermittent stimulation will be quantified.
Key facts
- Study ID
- NCT02112786
- Run by
- Loma Linda University
- People needed
- 0
- Starts
- 2015-01-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-01-26
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients age 18 to 85 with overactive bladder symptoms refractory to behavioral and anticholinergic therapy, detrusor overactivity on urodynamic study, surgically fit with ability to complete study forms, use patient programmer, and return for follow-up.
- Patients must have attempted and failed noninvasive therapy for overactive bladder symptoms for at least 6 months prior to enrollment; previous treatments will be recorded. In addition, patients must be fluent in the English language to complete informed consent paperwork and study questionnaires.
You may not qualify if…
- dementia,
- neurological conditions (spinal cord injury, multiple sclerosis),
- non-English speaking,
- acute urinary tract infection,
- primary pelvic pain,
- pregnancy or breast-feeding,
- urinary retention (postvoid residual greater than 100mL),
- history of bladder cancer in the past 5 years,
- history of nephrolithiasis or ureterolithiasis,
- anticoagulant therapy,
- implanted pacemaker/defibrillator, or
- anticipated need for future MRI.
Where it is running
- Loma Linda University Faculty Medical Offices — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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