Clinical trial NCT03596671: BlueWind RENOVA iStim™ System for the Treatment of OAB
Official title: A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment of Patients Suffering From Overactive Bladder (OAB)
Lead sponsor: BlueWind Medical
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in urinary urgency incontinence (UUI) episodes based on patient voiding diary
timeFrame: 6 months
measure: Safety - incidence of adverse events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Norwalk
country: United States
facility: Norwalk Urology
state: Connecticut
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Lake Barrington
country: United States
facility: Comprehensive Urologic Care
state: Illinois
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology - Hanover
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology - Owing Mills
state: Maryland
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology
state: Nebraska
city: Durham
country: United States
facility: Duke Urogynecology
state: North Carolina
city: West Columbia
country: United States
facility: Southern Urogynocology
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Leuven
country: Belgium
facility: UZ Leuven
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zwolle
country: Netherlands
facility: Isala
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College, St. Mary's Hospital
Study officials:
affiliation: Maastricht University Medical Centre
name: John Heesakkers, MD
role: PRINCIPAL_INVESTIGATOR
References: