Neuromodulation Implantation Settings Variation for Overactive Bladder
- Conditions
- Overactive Bladder
- Interventions
- Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
- Registration Number
- NCT02112786
- Lead Sponsor
- Loma Linda University
- Brief Summary
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.
- Detailed Description
The objective 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. Manufacturers recommended settings for newly implanted impulse generators (IPG); however, no standardized recommendations exist for further adjustments. Quality studies examining IPG parameters are lacking, partly due to the numerous setting variables, which can result in a multitude of permutations. When programming an IPG, an option for cycling simulation (16 seconds on, 8 seconds off) is available. It is theorized that because of a "carryover" effect, symptom relief will continue despite the stimulator being off. The potential benefit of the intermittent stimulation is an improved battery life, which may translate into a less frequent need for reimplantation with less morbidity. Participants receiving neuromodulation treatment for overactive bladder symptoms will be routinely fitted with an impulse generator in a pre-study phase. Patients who experience significant symptomatic improvement will receive a full bilateral sacral neuromodulator implantation and will be randomized to either intermittent or continuous stimulation. Participants will fill out voiding logs and surveys over a 12 week period. At that point, a one-week washout period during which the neuromodulator will be turned off. The impulse generator will then be turned to the alternate setting (intermittent or continuous) and the 12 week period will be repeated. Questionnaires and voiding diaries will be collected at each clinic visit. In total, subject participation will last approximately 25 weeks after full implantation of the bilateral leads and pulse generator.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intermittent then Continuous Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator This group will be set to intermittent stimulation first, then after the wash out period they will be switched to continuous stimulation. Continuous Then Intermitent Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator This group will be set to continuous stimulation first, then switch to intermittent after the wash out time period.
- Primary Outcome Measures
Name Time Method Overactive Bladder Symptoms Week 0, 2, 12, 13, 15, 25 Symptom improvement with be tracked for overactive bladder symptoms through voiding logs and questionnaires.
- Secondary Outcome Measures
Name Time Method Battery Life Week 0, 1, 12, 13, 15, 25 Battery life of the implanted device will be interrogated at each follow up visit to measure longevity of battery.
Trial Locations
- Locations (1)
Loma Linda University Faculty Medical Offices
🇺🇸Loma Linda, California, United States