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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)
Female aged 18 or greater (21 in the US)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

OASIS Trial 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.Check my eligibility
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.See study design
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.

OASIS Trial Eligibility Criteria

Inclusion Criteria

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

OASIS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary
Safety - incidence of adverse events

OASIS 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
University of California Irvine
Chesapeake Urology - Owing Mills
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I think this is important research sinc I know someone who had this problem.
PatientReceived 2+ prior treatments
~35 spots leftby Mar 2025