Implantable system for treating overactive bladder
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)
This study is testing a new implantable device to see if it can safely help people with overactive bladder feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | BlueWind Medical Industry-sponsored |
| Locations | 23 sites (Orange, California and 22 other locations) |
| Trial ID | NCT03596671 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the BlueWind RENOVA iStim™ implantable tibial neuromodulation system in patients diagnosed with overactive bladder (OAB). It is a prospective, interventional, multi-center study that aims to provide a new treatment option for individuals suffering from this condition. Participants will be monitored for their response to the device and any potential side effects over the course of the study.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 or older with a history of urinary urge incontinence for at least six months.
Not a fit: Patients with predominant stress incontinence or significant medical conditions that may interfere with the study procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder control and quality of life for patients with overactive bladder.
How similar studies have performed: Other studies have shown promise with neuromodulation techniques for bladder control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orange, California and 22 other locations
- University of California Irvine — Orange, California, United States (Active_not_recruiting)
- Kaiser Permanente — San Diego, California, United States (Recruiting)
- Norwalk Urology — Norwalk, Connecticut, United States (Completed)
- Florida Urology Partners — Tampa, Florida, United States (Completed)
- Comprehensive Urologic Care — Lake Barrington, Illinois, United States (Recruiting)
- Regional Urology, LLC — Shreveport, Louisiana, United States (Active_not_recruiting)
- Chesapeake Urology - Hanover — Hanover, Maryland, United States (Active_not_recruiting)
- Chesapeake Urology - Owing Mills — Owings Mills, Maryland, United States (Active_not_recruiting)
- Minnesota Urology — Woodbury, Minnesota, United States (Active_not_recruiting)
- Adult Pediatric Urology & Urogynecology — Omaha, Nebraska, United States (Active_not_recruiting)
- Duke Urogynecology — Durham, North Carolina, United States (Active_not_recruiting)
- Southern Urogynocology — West Columbia, South Carolina, United States (Completed)
- Sanford Health — Sioux Falls, South Dakota, United States (Completed)
- University of Washington — Seattle, Washington, United States (Recruiting)
- University Hospital Antwerp — Antwerp, Belgium (Completed)
- UZ Leuven — Leuven, Belgium (Completed)
- Rijnstate Hospital — Arnhem, Netherlands (Completed)
- Academic Hospital Maastricht — Maastricht, Netherlands (Completed)
- Radboud University Medical Center — Nijmegen, Netherlands (Completed)
- UMC Utrecht — Utrecht, Netherlands (Completed)
- Isala — Zwolle, Netherlands (Completed)
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom (Completed)
- Imperial College, St. Mary's Hospital — London, United Kingdom (Completed)
Study contacts
- Principal investigator: John Heesakkers, MD — Maastricht University Medical Centre
- Study coordinator: Roni Diaz
- Email: roni.diaz@bluewindmedical.com
- Phone: (469) 423 -2015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.