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Neuromodulation Device

RENOVA iStim™ System for Overactive Bladder (OASIS Trial)

N/A
Recruiting
Led By John Heesakkers, MD
Research Sponsored by BlueWind Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female aged 18 or greater (21 in the US)
Patient who is mentally competent with the ability to understand and comply with the requirements of the study
Must not have
Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new implantable device to treat overactive bladder. The device is placed near the tibia and sends electrical signals to the nerves that control the bladder. The study will evaluate the safety and efficacy of the device.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, similar neuromodulation treatments can cause discomfort at the implant site, movement issues of the stimulated limb, changes in bowel movements or urinary patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18 or older (21 or older in the US).
Select...
I understand and can follow the study's requirements.
Select...
I have been diagnosed with urge urinary incontinence for 6 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with interstitial cystitis or bladder pain syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment armExperimental Treatment1 Intervention
RENOVA iStim™ System implanted patients

Find a Location

Who is running the clinical trial?

BlueWind MedicalLead Sponsor
9 Previous Clinical Trials
482 Total Patients Enrolled
John Heesakkers, MDPrincipal InvestigatorMaastricht University Medical Centre
3 Previous Clinical Trials
1,110 Total Patients Enrolled

Media Library

RENOVA iStim™ System (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT03596671 — N/A
Overactive Bladder Research Study Groups: Treatment arm
Overactive Bladder Clinical Trial 2023: RENOVA iStim™ System Highlights & Side Effects. Trial Name: NCT03596671 — N/A
RENOVA iStim™ System (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596671 — N/A
Overactive Bladder Patient Testimony for trial: Trial Name: NCT03596671 — N/A
~31 spots leftby Dec 2025
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