Revolutionizing, new technology might change everything for people who suffer from overactive bladder. BlueWind Medical’s new device, the RENOVA™ iStim, is small, minimally invasive, and already having positive effects. This patient centric, home based therapy could be suitable for many patients as a way to reduce or completely end symptoms related to overactive bladder (OAB).
Those who suffer from overactive bladder already know the frustrating symptoms that come with it: sudden, intense urges to urinate, or the fear that they may involuntarily urinate if they don’t go to the restroom right away. Even worse, people with OAB might even accidentally leak urine when those sudden urges start to spike, or they might simply have to use the restroom far more often than normal.
These symptoms are more than frustrating or anxiety inducing, they’re embarrassing. Needing to constantly be aware of where to find the nearest restroom and having to frequently interrupt activities can leave people with OAB feeling like a burden when spending time with friends or family, and that stress is magnified when the urges interrupt professional meetings or important events.
What’s interesting is that, while many of those who have OAB feel embarrassment for it, OAB is actually surprisingly common. According to the American Urological Association, more than 33 million Americans have OAB, with one-third of all Americans aged 40 and over reporting that they have some level of urinary incontinence “at least sometimes.”
Despite the fact that OAB is such a widely experienced, commonplace problem, nearly half of all patients refuse to seek treatment. Reasons often come from embarrassment or shame, but also because the treatment that exists either doesn’t fully work, or else they demand a major sacrifice of the patient’s time and money. Physical training, such as Kegel exercises, and dietary changes can also occasionally help, but again, the results aren’t guaranteed. More invasive treatments exist, but all have their own drawbacks: Botox injections can deaden surface nerves of the bladder but require repeated treatments, Sacral Nerve Modulation (SNM) devices are large and require an invasive lower back surgery under full anesthesia. Percutaneous Tibial Nerve Modulation (PTNM) therapy requires weekly visits to a clinic to administer treatment.
BlueWind’s RENOVA™ iStim, however, is looking to usher in an entire new age of OAB treatment. Tiny and cutting out the need for frequent trips to the doctor, the RENOVA™ iStim is truly a revolution in the field of OAB treatment. Just over an inch long and a fraction of that in circumference, the RENOVA™ stimulator is implanted in a patient’s ankle in a simple procedure under local anesthesia. With the tiny stimulator in place, patients are able to perform Tibial Nerve Modulation (TNM) therapy treatments from the comfort and privacy of their own home using an ankle bracelet that wirelessly connects to the implanted stimulator. Patients wear the bracelet to initiate therapy for only 30 minutes, twice a day. The bracelet is lightweight and the patient can walk around and continue with their daily life while the device is stimulating.
This technology is revolutionary not only in the far-less invasive surgical procedure needed to implant the stimulator, but also for the simple fact that patients won’t need to frequent doctors’ offices as often. The stimulator’s smaller size and lack of wiring also means far fewer complications concerning shifting or infection, which leads to some patients using the current SNM technology to have to return for additional surgical procedures.
It feels like science fiction, but the results speak for themselves. From their initial study group, BlueWind found that 71% of patients in the pilot study using the RENOVA™ iStim have experienced at least a 50% decline in OAB symptoms, and 28% of their patients became “dry,” experiencing an entire stoppage to all leaking. The company is in the process of running a pivotal study with the hope of receiving FDA marketing clearance within the next two years.
The RENOVA™ iStim system’s patient-focused tech allowing the freedom of at-home treatment, a far simpler implantation procedure, and wireless treatment and battery charging certainly reveals that the future of OAB treatment is being changed in a revolutionary way.
A new day is coming, and BlueWind’s innovation is paving the way to freedom from OAB. Learn more about Bluewind Medical and the RENOVA™ iStim by visiting BluewindMedical.com
To see if you are eligible to participate in the study, please visit oasisoabstudy.com for qualification information.
Follow Bluewind Medical on social media: @bluewindmedical
Disclaimer: Investigational device. Limited by Federal or United States) law to investigational us.
