Revi System for Urge Incontinence

Recruiting at 18 trial locations

Overseen By Nitya Abraham, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BlueWind Medical

Must be taking: Antimuscarinics, Beta-3 agonists

Disqualifiers: High surgical risk, BMI >50, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Revi System, designed to assist individuals with urgency incontinence, characterized by a sudden, strong need to urinate. The trial compares two groups: one activates the device four weeks after implantation, while the other delays activation for four months. Individuals who have experienced urgency incontinence for at least six months and have frequent leaking episodes may be suitable candidates. Participants should be willing to use diaries and attend follow-up visits as part of the study. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new solutions for urgency incontinence.

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 prior data suggests that the Revi System is safe for treating urge incontinence?

Research has shown that the Revi System is generally safe for treating urgency incontinence. In a large study, 151 patients with this condition received the Revi implant, and 97% reported satisfaction with the treatment after two years. This high satisfaction rate indicates that the treatment is well-tolerated.

The Revi System is also FDA-cleared, meaning it has met safety standards for use in people. Another study found that 78.4% of patients experienced a significant improvement in symptoms, with at least a 50% reduction in urinary urgency. This improvement demonstrates the treatment's effectiveness and safety.

Overall, these findings suggest that the Revi System is a safe option for managing urgency incontinence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for urge incontinence, like medications and pelvic floor exercises, aim to manage symptoms but don't always address the underlying nerve signals causing the issue. The Revi System is unique because it targets those nerve signals directly through a small implant, potentially offering a more targeted and effective solution. Researchers are excited about the Revi System because it offers a new delivery method for therapy that could provide more sustained relief compared to conventional treatments. Additionally, the option to delay activation provides flexibility, allowing for a customized approach to managing symptoms.

What evidence suggests that the Revi System is effective for urge incontinence?

Research has shown that the Revi System effectively treats urgency incontinence. One study found that 79% of patients experienced at least a 50% reduction in symptoms after using the system for two years. Another report indicated a similar success rate of about 78% over the same period. These studies also highlighted high patient satisfaction and the system's safety. This trial will compare two approaches: one group will have the Revi System activated approximately 4 weeks post-implantation, while another group will have delayed activation until 4 months post-implantation. Many participants in these studies saw significant symptom improvement without major side effects. ^{2 3 6 7 8}

Who Is on the Research Team?

Lori Fein

Principal Investigator

BlueWind Medical

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Revi System - Delayed Activation
• Revi System Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Device: Revi System Treatment Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 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

Who Is Running the Clinical Trial?

BlueWind Medical

Lead Sponsor

Trials

10

Recruited

680+

Published Research Related to This Trial

The eCoin® neuromodulation device, implanted in 46 participants with refractory urgency urinary incontinence, demonstrated a significant 71% reduction in daily episodes of incontinence after 3 months, indicating its efficacy in treating this condition.

The device was found to be safe, with only one serious adverse event related to wound care, which was resolved with treatment, suggesting minimal safety concerns associated with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. MacDiarmid, S., Staskin, DR., Lucente, V., et al.[2019]

In a study involving six paraplegic patients with urinary incontinence due to an overactive bladder, pelvic floor stimulation using implanted electrodes led to significant improvements, with four patients experiencing reduced incontinence and two achieving complete resolution.

Urodynamic tests showed that the procedure effectively increased bladder capacity and inhibited detrusor overactivity, suggesting that this method could be a reliable long-term treatment option for urinary incontinence in spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical pelvic floor stimulation: a possible alternative treatment for reflex urinary incontinence in patients with spinal cord injury. Ishigooka, M., Hashimoto, T., Hayami, S., et al.[2019]

Functional electrical stimulation (FES) can effectively enhance bladder voiding in patients with incontinence, particularly through the use of the Finetech-Brindley bladder system that stimulates sacral roots.

A new approach is being developed to use FES for incontinence in spinal cord injury patients without the need for dorsal rhizotomy, which traditionally eliminates important reflexes like defecation and erection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review on Functional Electrical Stimulation of Bladder and Bowel in Spinal Cord Injury. Steers, WD., Wind, TC., Jones, EV., et al.[2019]

In a study of 46 patients with stress urinary incontinence, biofeedback and pelvic electric stimulation treatments resulted in a 93% improvement rate, demonstrating high efficacy for this intervention.

The treatment was effective regardless of menopause status, body mass index (BMI), or severity of incontinence, indicating that these factors do not significantly impact the success of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of biofeedback and pelvic electric stimulation in treatment of stress urinary incontinence]. Feng, J., Wang, XP., Chen, GM., et al.[2008]

The sacral anterior root stimulator, combined with sacral posterior rhizotomy, has proven effective for treating urinary incontinence in patients with spinal cord injuries and is expected to have broader applications.

The conditional pudendal nerve stimulator and conditional gracilis nerve stimulator are emerging treatments that show potential for helping many patients, although they have not yet been widely tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of urinary and faecal incontinence by surgically implanted devices. Brindley, GS.[2019]

In a study of 112 women with mixed urinary incontinence, the combination of transobturator tape (TOT) and posterior tibial nerve stimulation (PTNS) significantly improved urinary function and quality of life compared to TOT alone.

The combined treatment resulted in better outcomes in peak flow rates, first voiding desire, and maximum cystometric capacity, indicating that sequential therapy is more effective for managing urinary incontinence symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential combined approach in patients with mixed urinary incontinence: surgery followed by posterior tibial nerve stimulation. Carletti, V., Yacoub, V., Grilli, D., et al.[2022]

The Urgent-SQ™ implant for posterior tibial nerve stimulation has been shown to be a safe and effective long-term treatment for refractory overactive bladder syndrome, with positive results observed in a 9-year follow-up of seven patients.

Most patients reported continued efficacy and ease of use of the device, with no significant complications such as migration or displacement of the implant, indicating its durability and patient tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urgent-SQ implant in treatment of overactive bladder syndrome: 9-year follow-up study. Janssen, DA., Farag, F., Heesakkers, JP.[2015]

The Axonics® System is an FDA-approved continuous sacral neuromodulation therapy that has been shown to be a safe and effective treatment for overactive bladder and urge urinary incontinence, providing significant patient satisfaction.

This device features a rechargeable, compact design that is MRI safe and offers a long battery life of approximately 15 years, although patients may face challenges related to the need for regular recharging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence. Wang, A., Rourke, E., Sebesta, E., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39585851/

Two-Year Efficacy and Safety Outcomes of the Pivotal ... Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile.

2. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004328

Two-Year Efficacy and Safety Outcomes of the Pivotal ... Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725006770

Two Year Results From the OASIS Pivotal Study using the ... The primary endpoint, UUI response rate (≥50% decrease in UUI episodes), was achieved and has been previously reported; UUI response rate was 77.8% (112/144), ...

4. bluewindmedical.com bluewindmedical.com/resource/published-data-demonstrate-excellent-safety-and-efficacy-and-reinforce-patient-satisfaction-with-revi-system-in-the-treatment-of-urge-urinary-incontinence/

Published Data Demonstrate Excellent Safety and Efficacy ... The trial results demonstrate a statistically significant improvement with a 78.4% clinical success rate as defined by at least a 50% reduction in UUI at 12 ...

5. ics.org ics.org/2024/abstract/167

Two-year Follow-up of Revi™ Therapy, Implantable Tibial ... Ninety-seven subjects (64%) completed the 24-month assessment, and of these 79% of these subjects were therapy responders (≥50% reduction in UUI ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN220073.pdf

Revi System - accessdata.fda.gov The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

7. bluewindmedical.com bluewindmedical.com/resource/https-bluewindmedical-com-resource-two-year-revi-therapy-data-reinforce-sustained-efficacy-and-safety-of-implantable-tibial-neuromodulation/

Two-Year Revi Therapy Data Reinforce Sustained Efficacy ... Revi's two-year, multi-center, single-arm pivotal trial demonstrated 97% of participants reported satisfaction with Revi Therapy at 24 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725006812

140 - Impact of Implantable Tibial Neuromodulation (iTNM) ... A total of 151 UUI patients underwent implantation. While all study participants had urgency predominant urinary incontinence, 41.1% (62/151) also presented ...