Revi System for Urge Incontinence
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: BlueWind Medical
Must be taking: Antimuscarinics, Beta-3 agonists
Disqualifiers: High surgical risk, BMI >50, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
Will I have to stop taking my current medications?
The trial requires that if you are taking antimuscarinics, beta-3 adrenergic agonists, tricyclic antidepressants, SSRIs, or SNRIs, you must be on a stable dose for a certain period before starting and remain on it throughout the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What data supports the effectiveness of the Revi System treatment for urge incontinence?
Research shows that similar treatments using electrical stimulation of the tibial nerve, like the eCoin® and Urgent-SQ™, have been effective in treating urgency urinary incontinence and overactive bladder syndrome, suggesting potential benefits for the Revi System as well.
12345How is the Revi System treatment different from other treatments for urge incontinence?
The Revi System treatment is unique because it involves a fully implanted device that provides electrical stimulation to the tibial nerve, which is different from traditional medications or external therapies. This approach is similar to other neuromodulation devices like the eCoin® and Axonics® systems, but it specifically targets the tibial nerve, potentially offering a novel method for managing urge incontinence.
13678Eligibility Criteria
This trial is for individuals experiencing urge incontinence or a combination of urge urinary incontinence and urgency. Specific eligibility details are not provided, but typically participants must meet certain health criteria to be included.Inclusion Criteria
I have been on a stable dose of my antidepressant for at least 3 months.
I agree to attend all follow-ups and can accurately complete all required diaries, questionnaires, exams, and tests.
Subject experiences a minimum of four (4) leaking episodes associated with urgency, with at least one episode per day for 2 days documented on a voiding diary for 3 consecutive days
+4 more
Exclusion Criteria
Subject has a life expectancy of less than 1 year
Subject participation in a clinical investigation with an active treatment arm within the past 90 days
I have had surgery for urinary incontinence or prolapse in the last year.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
5 ± 4 weeks
1 visit (in-person)
Randomization & Implantation
Eligible subjects are randomized and undergo unilateral implantation with the BlueWind Revi System
1 day
1 visit (in-person)
Activation
Subjects undergo parameter setting and training on the use of the system after a recovery period
4 weeks post-implantation for Treatment Arm, 4 months for Control Arm
1 visit (in-person)
Treatment Optimization and Follow-up
Follow-up visits for treatment optimization and monitoring, including completion of a 3-day voiding diary
24 months
7 visits (in-person), 1 call visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Participant Groups
The RESTORE trial is testing the Revi System's effectiveness for treating symptoms of urgency incontinence. Participants will receive either immediate or delayed treatment with the Revi System to compare outcomes.
2Treatment groups
Experimental Treatment
Group I: Device: Revi System Treatment ArmExperimental Treatment1 Intervention
Subjects will be implanted with a Revi System and activation of therapy will occur \~4 weeks post implantation and continue for the duration of the study.
Group II: Device: Revi System - Delayed Activation Control ArmExperimental Treatment1 Intervention
Subjects will be implanted with a Revi System and activation of therapy will be delayed until 4 months post implantation. At this time the Revi System will be activated to begin therapy and will continue for the duration of the study.
Revi System - Delayed Activation is already approved in United States for the following indications:
🇺🇸 Approved in United States as Revi System for:
- Urgency incontinence alone or in combination with urinary urgency
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern - Department of UrologyDallas, TX
Adult and Pediatric Urology and UrogynecologyOmaha, NE
The Urology PlaceSan Antonio, TX
University Hospitals Cleveland Medical CenterCleveland, OH
More Trial Locations
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Who Is Running the Clinical Trial?
BlueWind MedicalLead Sponsor
References
Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. [2019]We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence.
Urgent-SQ implant in treatment of overactive bladder syndrome: 9-year follow-up study. [2015]Electrical stimulation of the posterior tibial nerve (PTN) is an established therapy for the treatment of refractory overactive bladder syndrome (OAB). The Urgent-SQ™ is an implant that is surgically placed near the PTN and activated by an external pulse generator, allowing for "on demand" PTN stimulation, without the need for needle insertion. The current study presents results of a 9-year, open-label, follow-up of eight patients to address the long term safety and efficacy of the implant.
A Review on Functional Electrical Stimulation of Bladder and Bowel in Spinal Cord Injury. [2019]The purpose of this collective review is to examine the use of functional electrical stimulation for incontinence. The Finetech-Brindley bladder system enhances voiding through stimulation via electrodes implanted around the ventral sacral roots. Detrusor hyperreflexia is eliminated through complete dorsal rhizotomy, which results in loss of reflex defecation and reflex erection/reflex lubrication. Consequently, a new system is being devised in which functional electrical stimulation for incontinence in spinal cord injury can be achieved without dorsal rhizotomy.
Sequential combined approach in patients with mixed urinary incontinence: surgery followed by posterior tibial nerve stimulation. [2022]The aim of the study is to demonstrate the efficacy of sequential combined treatment with Transobturator Tape (TOT) followed by Posterior Tibial Nerve Stimulation (PTNS) in patients with Mixed Urinary Incontinence (MUI); quality of life and patients' satisfaction was also assessed.
[Effects of biofeedback and pelvic electric stimulation in treatment of stress urinary incontinence]. [2008]To investigate procedures and benefits of using bio-feedback and pelvic electric stimulation in treatment of stress urinary incontinence.
Electrical pelvic floor stimulation: a possible alternative treatment for reflex urinary incontinence in patients with spinal cord injury. [2019]The present study demonstrates the clinical experience of pelvic floor stimulation using percutaneous implantable electrodes and implantable electrical stimulator for the treatment of reflex urinary incontinence in patients with spinal cord injury. Pelvic floor stimulation was carried out on six paraplegic patients who had urinary incontinence from an overactive bladder. After the percutaneous implantation of a pair of electrodes, chronic stimulation was carried out by employing an implanted receiver or an external pulse regulator. Within 4 to 16 weeks of electrical stimulation urinary incontinence was improved in four of the six patients. In two of these six patients, incontinence was completely abolished subjectively. Urodynamic investigations demonstrated an increased volume at the first unstable contraction (P
Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence. [2021]Introduction: Overactive bladder and urge urinary incontinence affect millions of women and men and results in billions of dollars in health-care expenses. First- and second-line therapy includes behavioral modifications and/or pharmacotherapies however, many patients' symptoms remain or progress on these treatments. There has been concern regarding the detrimental side effects of the most widely prescribed medications for these bladder symptom management.Areas covered: As a result, there has been increased interest in continuous sacral neuromodulation, an FDA approved therapy for refractory urinary urgency and urge urinary incontinence. In this article, we specifically review current research on the efficacy and patient/provider satisfaction and safety profile of the Axonics® System. In addition, we address the current state of sacral neuromodulation and potential future direction and applicability.Expert opinion: The Axonics® system is a safe effective device for the treatment of overactive bladder and urinary urge incontinence. Additionally, it affords patient's the convenience of a rechargeable, compact, MRI safe system. It should be noted that the rechargeable system, while allowing for approximately 15 years of battery and lead life, may have its challenges in terms of charge burden. Furthermore, this system is easily adapted for experienced implanters of sacral neuromodulating devices.
Treatment of urinary and faecal incontinence by surgically implanted devices. [2019]Three kinds of implant to treat incontinence are considered. The sacral anterior root stimulator (with sacral posterior rhizotomy) is already effective in urinary incontinence due to spinal cord injury, and will have wider application. The conditional pudendal nerve stimulator and the conditional gracilis nerve stimulator are, respectively, almost untried and entirely untried devices; but they show promise, and if successful may help very many patients.