RENOVA iStim™ System for Overactive Bladder

(OASIS Trial)

Recruiting at 29 trial locations

Overseen By Felicia Lane, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: BlueWind Medical

Disqualifiers: Breastfeeding, Stress incontinence, Interstitial cystitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

282 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the RENOVA iStim™ System, an implantable device designed to help people with overactive bladder (OAB). The goal is to determine if this system is safe and effective in reducing symptoms such as frequent urination and sudden urges. Women who have experienced overactive bladder symptoms for at least six months and can mentally follow the study's requirements may be suitable candidates for this trial.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance future treatments for OAB.

What prior data suggests that the RENOVA iStim™ System is safe for treating overactive bladder?

Research has shown that the RENOVA iStim™ System is safe for treating overactive bladder. In a study with 151 patients, the system proved safe for those whose bladder problems could not be resolved by other treatments. The study reported no major safety concerns. The system has also demonstrated long-term safety and effectiveness, working well over time without causing serious issues. Patients have generally tolerated it well, with only a few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RENOVA iStim™ System because it offers a novel approach to managing overactive bladder by using a small implantable device that directly stimulates the tibial nerve. Unlike standard treatments like medications or behavioral therapies, which can have varying effectiveness and side effects, this system provides a targeted and minimally invasive solution. By focusing on nerve stimulation, the RENOVA iStim™ System has the potential to reduce symptoms more effectively and with fewer side effects, offering new hope for patients who haven't found relief from existing therapies.

What evidence suggests that the RENOVA iStim™ System is effective for overactive bladder?

Research has shown that the RENOVA iStim™ System, which participants in this trial will receive, can help treat overactive bladder. One study found that 56% of patients experienced a significant reduction in sudden urges to urinate, with some seeing a 75% decrease. Additionally, 28% of patients reported being completely dry. Another study found that 80% of patients were satisfied with their results, experiencing fewer sudden urges to urinate three months after treatment. These findings suggest that the RENOVA iStim™ System can offer promising relief for those with overactive bladder symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

John Heesakkers, MD

Principal Investigator

Maastricht University Medical Centre

Are You a Good Fit for This Trial?

This trial is for mentally competent women aged 18+ (21+ in the US) who have been diagnosed with overactive bladder (OAB) for at least 6 months. It's not suitable for those with significant medical conditions that could affect the study, breastfeeding women, patients with mainly stress incontinence, a life expectancy under one year, or those diagnosed with interstitial cystitis/bladder pain syndrome.

Inclusion Criteria

I am a woman aged 18 or older (21 or older in the US).

I understand and can follow the study's requirements.

I have been diagnosed with urge urinary incontinence for 6 months or more.

Exclusion Criteria

Mainly experiencing stress incontinence.

The doctors think you may have less than a year to live.

I have been diagnosed with interstitial cystitis or bladder pain syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RENOVA iStim™ System implant for tibial neuromodulation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RENOVA iStim™ System

Trial Overview The OASIS study is testing the BlueWind RENOVA iStim™ System's safety and effectiveness. This system is an implantable device designed to treat overactive bladder by stimulating nerves in the tibia.

How Is the Trial Designed?

Group I: Treatment arm Experimental Treatment 1 Intervention

RENOVA iStim™ System implanted patients

Who Is Running the Clinical Trial?

BlueWind Medical

Lead Sponsor

Trials

10

Recruited

680+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03596671

BlueWind RENOVA iStim™ System for the Treatment of OAB ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes, Proportion of responders at 6 months post system activation as demonstrated by ≥50% ...

2. ics.org ics.org/2024/abstract/456

Feasibility of replacing the tibial nerve neuromodulation ... The RENOVA iStim System™ is a promising therapeutic option in neuromodulation for overactive bladder. The revision procedure proved safe and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32271689/

3-Year Followup of a New Implantable Tibial Nerve ... This 3-year followup study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725009026

Feasibility of Replacing a Tibial Nerve Neuromodulation ... In terms of efficacy, 80% (4/5) patients were satisfied with the results at three months after revision. They reported a reduction in the UUI, a ...

5. bluewindmedical.com bluewindmedical.com/providers/clinical-outcomes/

Clinical Outcomes for UUI Treatment 56%. of patients had ≥ 75% reduction in UUI episodes. 28%. of patients were dry on a 3 day diary.

6. urologytimes.com urologytimes.com/view/renova-istim-system-shows-safety-in-refractory-overactive-bladder

RENOVA iStim System shows safety in refractory ... The BlueWind RENOVA iStim System demonstrated safety in a cohort of 151 patients undergoing treatment for refractory overactive bladder.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.25477

A prospective study to assess the effectiveness and safety ... The Revi System demonstrated clinically meaningful and statistically significant improvement in an ITT analysis, in urgency incontinence ...

8. ics.org ics.org/2021/abstract/332

ICS 2021 Abstract #332 OASIS Pivotal Trial to Evaluate ... A pivotal trial is being conducted to evaluate the safety and efficacy of the RENOVA iStim System for treating refractory OAB patients.

9. auajournals.org auajournals.org/doi/10.1097/01.JU.0000556189.77639.e5

RENOVA ISTIM™ SYSTEM The BlueWind Medical RENOVA iStim System for the treatment of OAB demonstrates long-term safety and efficacy results as well as sustainable ...