New investigational study for adults with Overactive Bladder (OAB)
The device used in the study is supplied by Bioness, Inc. To be considered as a study participant, please contact your medical care provider. CAUTION – INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL LAW TO INVESTIGATIONAL USE.
About the study
Have you tried OAB medications and therapies but are not pleased with the results?
Many people suffer from OAB. Symptoms of OAB may include sudden urges to urinate, incontinence and the need to pass urine frequently. Common treatments such as behavioral therapy and OAB medications often fail to provide acceptable relief from these symptoms.
Why is this study being conducted?
The goal of this study is to determine if a new medical device, StimRouter, can provide safe and effective relief from persistent symptoms of OAB.
Are there benefits to taking part in the study?
The treatment may reduce your OAB symptoms and improve your quality of life; however, these cannot be guaranteed.
To join the study, you must:
- Be 22 years of age or older
- Not have diabetes
- Pass urine more than 10 times per day
- Not be pregnant and not be planning to become pregnant.
What are the costs of the study?
There should be no cost to you or to your insurance company for participating in the study.
How long will you be in the study?
The study requires approximately 9 office visits over approximately 6 months. Each office visit will be about 45 to 60 minutes long.
Learn more
Rx Only. The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region. StimRouter is contraindicated in patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or metallic implant in the immediate area intended for implant. For complete instructions for use, storage, warnings, indications, contraindications, precautions, adverse reactions and disclaimer of warranties, please refer to the insert accompanying each product or online at www.stimrouter.com.