Neuromodulation Implantation Settings Variation for Overactive Bladder
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ClinicalTrials.gov Identifier: NCT02112786 |
Recruitment Status
:
Withdrawn
First Posted
: April 14, 2014
Last Update Posted
: January 26, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overactive Bladder | Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Intermittent Versus Continuous Stimulation in Bilateral Sacral Neuromodulation for Overactive Bladder |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Intermittent then Continuous
This group will be set to intermittent stimulation first, then after the wash out period they will be switched to continuous stimulation.
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Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.
Other Name: RestorePrime Implanted Impulse Generator
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Active Comparator: Continuous Then Intermitent
This group will be set to continuous stimulation first, then switch to intermittent after the wash out time period.
|
Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.
Other Name: RestorePrime Implanted Impulse Generator
|
- Overactive Bladder Symptoms [ Time Frame: Week 0, 2, 12, 13, 15, 25 ]Symptom improvement with be tracked for overactive bladder symptoms through voiding logs and questionnaires.
- Battery Life [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112786
United States, California | |
Loma Linda University Faculty Medical Offices | |
Loma Linda, California, United States, 92354 |
Principal Investigator: | Andrea Staack, MD, Phd | Loma LindaUniversity Medical Center |
Publications:
Responsible Party: | Loma Linda University |
ClinicalTrials.gov Identifier: | NCT02112786 History of Changes |
Other Study ID Numbers: |
STIM-1 SUFU ( Other Identifier: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) ) |
First Posted: | April 14, 2014 Key Record Dates |
Last Update Posted: | January 26, 2015 |
Last Verified: | January 2015 |
Keywords provided by Loma Linda University:
Overactive Bladder |
Additional relevant MeSH terms:
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms |