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BlueWind RENOVA iStim™ System for the Treatment of OAB

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Conditions

Treatment of Patients Suffering From Overactive Bladder (OAB)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2019-06-12
Study Completion:2025-01-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03596671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female aged 18 or greater (21 in the US)
  2. * More than or equal to 6 months history of UUI diagnosis
  3. * Patient who is mentally competent with the ability to understand and comply with the requirements of the study
  1. * Any significant medical condition that is likely to interfere with study procedures
  2. * Patients who are breastfeeding
  3. * Predominant stress incontinence
  4. * Have a life expectancy of less than 1 year
  5. * Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines

Contacts and Locations

Principal Investigator

John Heesakkers, MD
PRINCIPAL_INVESTIGATOR
Maastricht University Medical Centre

Study Locations (Sites)

University of California Irvine
Orange, California, 92868
United States
Kaiser Permanente
San Diego, California, 92110
United States
Norwalk Urology
Norwalk, Connecticut, 06850
United States
Florida Urology Partners
Tampa, Florida, 33615
United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
United States
Regional Urology, LLC
Shreveport, Louisiana, 71106
United States
Chesapeake Urology - Hanover
Hanover, Maryland, 21076
United States
Chesapeake Urology - Owing Mills
Owings Mills, Maryland, 21117
United States
Minnesota Urology
Woodbury, Minnesota, 55125
United States
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
United States
Duke Urogynecology
Durham, North Carolina, 27707
United States
Southern Urogynocology
West Columbia, South Carolina, 29169
United States
Sanford Health
Sioux Falls, South Dakota, 57105
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: BlueWind Medical

  • John Heesakkers, MD, PRINCIPAL_INVESTIGATOR, Maastricht University Medical Centre

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-12
Study Completion Date2025-01-24

Study Record Updates

Study Start Date2019-06-12
Study Completion Date2025-01-24

Terms related to this study

Additional Relevant MeSH Terms

  • Treatment of Patients Suffering From Overactive Bladder (OAB)