RENOVA iStim™ System for Overactive Bladder
(OASIS Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen byJohn Heesakkers, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: BlueWind Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.

Research Team

John Heesakkers, MD

Principal Investigator

Maastricht University Medical Centre

Eligibility Criteria

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.

See 2 more

Treatment Details

Interventions

RENOVA iStim™ System (Neuromodulation Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment armExperimental Treatment1 Intervention

RENOVA iStim™ System implanted patients