BlueWind RENOVA iStim™ System for the Treatment of OAB

Not Applicable

Recruiting

• Conditions: Treatment of Patients Suffering From Overactive Bladder (OAB)
• Interventions: Device: RENOVA iStim™ System

• 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
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-03
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Arm && Interventions

Group	Intervention	Description
Treatment arm	RENOVA iStim™ System	RENOVA iStim™ System implanted patients

Primary Outcome Measures

Name	Time	Method
Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary	6 months
Safety - incidence of adverse events	12 months

Trial Locations

Locations (23)

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium

Isala; 🇳🇱 Zwolle, Netherlands

University of Washington; 🇺🇸 Seattle, Washington, United States

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

Southern Urogynocology; 🇺🇸 West Columbia, South Carolina, United States

Academic Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

Imperial College, St. Mary's Hospital; 🇬🇧 London, United Kingdom

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

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

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

Norwalk Urology; 🇺🇸 Norwalk, Connecticut, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

Sanford Health; 🇺🇸 Sioux Falls, South Dakota, United States

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Birmingham Women's and Children's NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

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

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

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

Duke Urogynecology; 🇺🇸 Durham, North Carolina, United States

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

Minnesota Urology; 🇺🇸 Woodbury, Minnesota, United States