Sacral Neuromodulation for Overactive Bladder
(PEER 2 Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: MedtronicNeuro
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial collects data on how the body functions throughout the treatment period. It aims to understand the effects of therapy by monitoring physiological signals. The specific patient group is not mentioned, suggesting it may include a wide range of participants.
Do I need to stop taking my current medications to join the trial?
No, you don't need to stop taking your current medications. In fact, you must maintain your current medication regimen (dosage and frequency) throughout the therapy evaluation period.
What data supports the idea that Sacral Neuromodulation for Overactive Bladder is an effective treatment?
The available research shows that Sacral Neuromodulation (SNM) is a well-established treatment for overactive bladder, especially when other treatments have not worked. It has been used successfully for nearly 40 years to help manage symptoms. One study highlights its effectiveness even after patients have tried other treatments like onabotulinumtoxinA. Additionally, SNM is noted for reducing the need for other interventions, such as catheterization, in patients with urinary retention, which suggests its effectiveness in improving bladder function.
12345What safety data is available for sacral neuromodulation in treating overactive bladder?
Sacral neuromodulation (SNM) has been used for over two decades since its approval in 1997 for treating overactive bladder (OAB) that is resistant to other treatments. Studies indicate that SNM is a safe and effective therapy for managing urinary and fecal incontinence. The InterStim devices, including the rechargeable InterStim Micro, have been evaluated for safety and clinical performance, with ongoing studies confirming their safety in treating OAB. Over 350,000 SNM devices have been implanted since FDA approval, with safety data collected over a decade providing insights for informed consent and patient counseling. Technological and surgical advancements in SNM have also contributed to improved safety and treatment success.
678910Is Sacral Neuromodulation a promising treatment for Overactive Bladder?
Yes, Sacral Neuromodulation is a promising treatment for Overactive Bladder. It is a minimally invasive procedure that uses a small device to send gentle electrical pulses to nerves in the lower back, helping to control bladder function. Many patients experience significant improvement, with more than three-quarters seeing a reduction in incontinence episodes by over 50%. It has been used successfully for nearly 40 years and is considered safe when performed by experienced professionals.
123411Eligibility Criteria
This trial is for adults with overactive bladder who can complete diaries, attend visits, and follow the study protocol. They must be candidates for or already receiving Medtronic InterStim lead implant therapy. Exclusions include stress incontinence dominance, urinary tract obstruction, enrollment in other studies that could affect results, recent tibial neuromodulation therapy, planned MRIs during the study period, pregnancy or planning to become pregnant, poor compliance likelihoods, certain neurological conditions like multiple sclerosis or spinal cord injury.Inclusion Criteria
I have been diagnosed with overactive bladder based on a voiding diary.
I am a candidate for or am getting a Medtronic InterStim device.
I have been diagnosed with overactive bladder based on my voiding diary.
+4 more
Exclusion Criteria
I have a blockage in my urinary tract.
My overactive bladder is due to surgery or injury.
I am aware of my upcoming diathermy treatment for overactive bladder.
+11 more
Participant Groups
The PEER 2 Study is testing sacral neuromodulation by collecting physiological signals at different times during the therapy evaluation period. It aims to understand how this treatment affects patients with bowel incontinence and overactive bladder symptoms.
1Treatment groups
Experimental Treatment
Group I: Pelvic health Electrically Evoked Recording (PEER) 2 StudyExperimental Treatment1 Intervention
Collect physiological signals
Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as InterStim for:
- Overactive bladder
- Urinary urgency
- Frequency
- Urge incontinence
- Nonobstructive urinary retention
- Chronic fecal incontinence
🇪🇺 Approved in European Union as InterStim for:
- Overactive bladder
- Urinary urgency
- Frequency
- Urge incontinence
- Nonobstructive urinary retention
- Chronic fecal incontinence
- Chronic constipation
🇨🇦 Approved in Canada as InterStim for:
- Overactive bladder
- Urinary urgency
- Frequency
- Urge incontinence
- Nonobstructive urinary retention
- Chronic fecal incontinence
- Chronic constipation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University Health Methodist Research InstituteIndianapolis, IN
Ochsner Clinic FoundationNew Orleans, LA
Mayo Clinic Urology/Urogynecology DepartmentRochester, MN
University Hospitals Cleveland Medical CenterCleveland, OH
More Trial Locations
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Who Is Running the Clinical Trial?
MedtronicNeuroLead Sponsor
References
[Sacral neuromodulation for refractory overactive bladder]. [2019]Sacral neuromodulation (SNM) is a minimally invasive, established treatment modality for overactive bladder (OAB) as well as for other pelvic functional disorders, such as non-obstructive urinary retention and fecal incontinence. A pacemaker implanted in the upper buttocks delivers mild electrical pulses to the sacral nerves thereby modulating pathological afferent signals from pelvic end organs. The current article conveys the current knowledge on the indications, contraindications, mechanism of action, implantation technique, efficacy and complications of SNM for the treatment refractory OAB.
[Sacral neuromodulation in under- and overactive detrusor-quo vadis? : Principles and developments]. [2022]Sacral neuromodulation (SNM) has been used in the treatment of refractory overactive bladder syndrome, nonobstructive urinary retention and faecal incontinence for almost 40 years now. It is not to be confused with the sacral anterior root stimulation which is exclusively used for bladder dysfunction due to spinal paraplegia.
Sacral neuromodulation for refractory overactive bladder after prior intravesical onabotulinumtoxinA treatment. [2018]Sacral neuromodulation (SNM) is a well-established treatment modality for refractory overactive bladder (OAB). There is a paucity of evidence examining the use of SNM in patients who have received prior intravesical onabotulinumtoxinA (BTXA) treatment. We aim to review those patients who underwent SNM for refractory OAB following treatment with BTXA.
Cost-effectiveness of test phase implantation strategies for InterStim® sacral neuromodulation. [2013]Sacral neuromodulation with InterStim can be performed with staged implants or peripheral nerve evaluation followed by a combined stage I/II procedure. In both, unilateral or bilateral leads can be placed for the testing phase. Our objective was to determine the cost-effectiveness of these strategies in patients with refractory overactive bladder.
Does sacral neuromodulation lead to relevant reduction in the need for intermittent catheterization? A single-center experience on patients with chronic urinary retention. [2022]Sacral neuromodulation (SNM) is an approved method for second-line treatment of different therapy refractory disorders of the urinary bladder. Alongside success in overactive bladder symptoms for detrusor overactivity, SNM also was shown to succeed in chronic urinary retention (UR) of various etiology.
Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study. [2020]Sacral neuromodulation (SNM) is a minimally invasive fully reversible therapy that was approved in 1997 for overactive bladder syndrome (OAB) refractory to behavior modification and pharmacotherapy. Despite being in use for over two decades, the data on medium to long-term safety and efficacy of SNM in OAB is limited. We investigated the medium-term efficacy and safety of SNM along with the predictive factors for its success in patients with refractory OAB.
Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. [2023]Sacral nerve neuromodulation (SNM) is a safe and effective therapy for the management of fecal and/or urinary incontinence. The generators InterStim™ and InterStim™ II (Medtronic™) are non-rechargeable active implantable medical devices with a limited lifespan. The aims of this study were to assess the generators' median lifespan for all indications and the long-term hospital costs of the therapy.
Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study. [2023]Label="AIMS">Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up.
Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database. [2023]Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting.
Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. [2008]This article accompanies a "surgery in motion" DVD on sacral neuromodulation (SNM) with InterStim Therapy, which visualizes the implantation of the InterStim II system. The article describes the technical and surgical developments of SNM and their impact on treatment success, safety, and patient's quality of life (QoL).
Sacral neuromodulation as a functional treatment of bladder overactivity. [2019]Sacral neuromodulation, namely the electrical stimulation of the sacral nerves has become an alternative treatment for cases of idiopathic bladder overactivity. The mechanism of action in this type of spinal cord modulation is only partially understood but it seems to involve stimulation of inhibitory interneurons. Temporary sacral nerve stimulation is the first step. It consists of the temporary application of neurostimulation as a diagnostic test in order to check the integrity of the sacral root and determine the best location for the implant. If the test stimulation is successful, a permanent device is implanted. In experienced hands, this is a safe procedure. When the patients are selected on the basis of sound criteria, more than three-quarters of them show a clinically significant improvement with a reduction in the frequency of incontinence episodes by more than 50%; however, the results vary according to each author's method of evaluation. The application of this technique should be combined with careful follow-up and attentive adjustments of the stimulation parameters in order to optimize the coordination of activity between the neurological systems involved.