Overactive BladderNCT02112786
Neuromodulation Implantation Settings Variation for Overactive Bladder
A study testing Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator in people with Overactive Bladder, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- dementia,
- neurological conditions (spinal cord injury, multiple sclerosis),
- non-English speaking,
- acute urinary tract infection,
- primary pelvic pain,
- pregnancy or breast-feeding,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Faculty Medical Offices
Loma Linda, California, 92354
About this study
Official title: Intermittent Versus Continuous Stimulation in Bilateral Sacral Neuromodulation for Overactive Bladder
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator
- Keywords
- Overactive Bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent or Continuous Setting RestorePrime Implanted Impulse GeneratorDevice
Also called RestorePrime Implanted Impulse Generator
This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent then Continuous | Active comparator | This group will be set to intermittent stimulation first, then after the wash out period they will be switched to continuous stimulation. Receives: Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator |
| Continuous Then Intermitent | Active comparator | This group will be set to continuous stimulation first, then switch to intermittent after the wash out time period. Receives: Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Symptoms
Symptom improvement with be tracked for overactive bladder symptoms through voiding logs and questionnaires.
Measured: Week 0, 2, 12, 13, 15, 25
Secondary outcomes (1)
Battery Life
Battery life of the implanted device will be interrogated at each follow up visit to measure longevity of battery.
Measured: Week 0, 1, 12, 13, 15, 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Staack, MD, Phd, Principal investigator, Loma LindaUniversity Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112786
- Sponsor's protocol ID
- STIM-1
- Other IDs
- SUFU
- Status last verified
- Jan 2015
- First submitted
- 9 Apr 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004 Mar;63(3):461-5. doi: 10.1016/j.urology.2003.10.037.
PubMed 15028438Nitti VW. Clinical impact of overactive bladder. Rev Urol. 2002;4 Suppl 4(Suppl 4):S2-6.
PubMed 16986018
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Stimulation in Bilateral Sacral Neuromodulation for Overactive Bladder
- ClinicalTrials.gov ID
- NCT02112786
- Acronym / sponsor ID
- STIM-1
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent then Continuous | Active comparator | Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse GeneratorThis group will be set to intermittent stimulation first, then after the wash out period they will be switched to continuous stimulation. |
| Continuous Then Intermitent | Active comparator | Device: Intermittent or Continuous Setting RestorePrime Implanted Impulse GeneratorThis group will be set to continuous stimulation first, then switch to intermittent after the wash out time period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- dementia,
- neurological conditions (spinal cord injury, multiple sclerosis),
- non-English speaking,
- acute urinary tract infection,
- primary pelvic pain,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent or Continuous Setting RestorePrime Implanted Impulse GeneratorAlso: RestorePrime Implanted Impulse GeneratorThis is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement. | Device | Continuous Then Intermitent, Intermittent then Continuous |
Primary outcome
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.
1 secondary outcome
Battery Life
Time frame: Week 0, 1, 12, 13, 15, 25
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 15028438Hu TW, Wagner TH, Bentkover JD, Leblanc K, Zhou SZ, Hunt T. Costs of urinary incontinence and overactive bladder in the United States: a comparative study. Urology. 2004 Mar;63(3):461-5. doi: 10.1016/j.urology.2003.10.037.
- Background: PubMed 16986018Nitti VW. Clinical impact of overactive bladder. Rev Urol. 2002;4 Suppl 4(Suppl 4):S2-6.
Related trials for Overactive Bladder
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Staack, MD, Phd principal investigator
Loma LindaUniversity Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator in people with Overactive Bladder, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive Bladder Symptoms (time frame: Week 0, 2, 12, 13, 15, 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112786, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.