BlueWind RENOVA iStim™ System for the Treatment of OAB

Not Applicable

Completed

• Conditions: Treatment of Patients Suffering From Overactive Bladder (OAB)

• Registration Number: NCT03596671
• Lead Sponsor: BlueWind Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-24
• Study Start: 2019-06-12
• Primary Completion: 2022-10-28
• Study Completion: 2025-01-24
• Results First Submitted: 2025-07-22
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Results First Posted: 2025-09-16
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 282

Inclusion Criteria

• Female aged 18 or greater (21 in the US)
• More than or equal to 6 months history of UUI diagnosis
• Patient who is mentally competent with the ability to understand and comply with the requirements of the study

Exclusion Criteria

• Any significant medical condition that is likely to interfere with study procedures
• Patients who are breastfeeding
• Predominant stress incontinence
• Have a life expectancy of less than 1 year
• Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes	6 months	Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.
Safety - Number of Participants With Adverse Events	12 months	The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).

Trial Locations

Locations (23)

University of California Irvine; 🇺🇸 Orange, California, United States

Kaiser Permanente; 🇺🇸 San Diego, California, United States

Norwalk Urology; 🇺🇸 Norwalk, Connecticut, United States

Florida Urology Partners; 🇺🇸 Tampa, Florida, United States

Comprehensive Urologic Care; 🇺🇸 Lake Barrington, Illinois, United States

Regional Urology, LLC; 🇺🇸 Shreveport, Louisiana, United States

Chesapeake Urology - Hanover; 🇺🇸 Hanover, Maryland, United States

Chesapeake Urology - Owing Mills; 🇺🇸 Owings Mills, Maryland, United States

Minnesota Urology; 🇺🇸 Woodbury, Minnesota, United States

Adult Pediatric Urology & Urogynecology; 🇺🇸 Omaha, Nebraska, United States

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