RENOVA iStim™ System for Overactive Bladder

(OASIS Trial)

Recruiting at 16 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

200 Participants Needed

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+