FDA OKs New Device for Overactive Bladder

A woman speaks to a healthcare worker.
A new device might help people with overactive bladder. Maskot/Getty Images
  • The FDA has given marketing approval to a new implant aimed at treating urinary incontinence.
  • The device focuses on reducing barriers to treatment for patients.
  • Experts say that this product is building upon already effective treatments and does have a use case.

In the U.S., approximately 33 million people are looking for treatment for urinary incontinence (UI) or overactive bladder according to the Urology Care Foundation.

One Utah-based company, BlueWind Medical is hoping that a recent FDA marketing approval could mean significant gains for patients. Their product, called the Revi System, is an implant that is meant to provide therapy without the need for patients to see their physician for follow-up as frequently. 

How the implant works

The implant is focues on posterior tibial neuromodulation therapy. This involves stimulating an area near the ankle to reduce symptoms of urinary incontinence or overactive bladder.

Dr. S. Adam Ramin , urologist and medical director of Urology Cancer Specialists in Los Angeles, says that the focus of this type of treatment is to trigger the specific nerves in the pelvis.

“The theory is that if you are stimulating these nerves then the stimulation will cause relaxation of the bladder muscle and takes away the overactivity or the urgency components of the bladder muscle,” Ramin said. “By doing that, then there’s less urgency, less frequency, and also less episodes where a person may leak urine with an urge to urinate.”

In BlueWind’s case that means the insertion of a transmitter and the wearing of an ankle-based device when treatment is conducted once or twice a day. That transmitter does not have a battery and measures 3 centimeters long and 3 in diameter.

Without this implant the therapy is done in person with a practicioner using an instrument similar to an acupuncture needle and an external device to stimulate the same area and reduce symptoms. But that can be costly and require a lot of time at a medical office for in-person treatment. The typical treatment plan for this therapy includes multiple months of weekly sessions followed by regular follow-ups.

Neuromodulation therapies, where nerve function is altered due to targeted stimuli, have a history in a variety of disciplines, not just urology. The International Neuromodulation Society dates some of the earliest confirmed clinical evidence of its effectiveness to the 1960s, while additional research has been done more recently into how neuromodulation can impact patients with spinal cord injuries

Who this device can help

Dr. Jennifer Linehan, urologist at Providence Saint John’s Health Center in Santa Monica who has been involved with research related to a similar product, says that one use case could be those for whom the amount of time it takes to get a more traditional treatment is prohibitive.

“For the patients it’s a time suck. If you’re retired it’s no big deal, but if you are younger and have a life and need to get things done, coming to your doctor’s office and blowing two hours in the day is not always possible. So, if the patients can do this at home, it’s going to save them a lot of time, they may be able to do treatments more frequently, which may help. And then it’s going to improve your treatment outcomes as well.”

However, Dr. David Shusterman, a urologist at NY Urology who is focused on minimally invasive treatment options, says that just because this new device is on the market doesn’t mean it’s inherently better than what can already be offered.

“I feel like, if we didn’t have that external stimulator and this came along, this would be great. The problem is that this came along about 15 years too late.”

Anecdotally, Linehan estimates the success rate of treatment at 50% of patients while Shusterman suggests that 85% of his clients see noticeable improvement.

The data shared by BlueWind puts their effectiveness at 82% when it came to those who halved their amount of “urge incontinence episodes” over a year.

Other ways to treat overactive bladder

The use of post-tibial neuromodulation therapy is just one of the options for those affected by urinary incontinence and overactive bladder.

For some, medications like oxybutynin and solifenacin are a common choice. If the therapy doesn’t work then the next step can be a procedure such as bladder botox, an option which is being explored more and more by some with physical disabilities. A third level of treatment, where an implant is inserted into the sacral nerve, is also available to patients.

Shusterman says that, regardless of what options you decide to take, you should be mindful of the side effects involved and the dangers of surgically implanting a device.

“I’m always skeptical of putting, foreign bodies into people because the risk of infection could be a problem. And, of course, it’s a surgical procedure, so you’re actually cutting through things and I think that there is some risk for nerve issues as well.”

Ramin says that a lot of the treatments for urgency urinary incontinence are focused on symptoms rather than root causes and that more research needs to be done to shore up and develop future options.

“We have some basic information on how the nerves through the spine and the hypogastric plexus work on the bladder, but our knowledge is really preliminary and the more research on this subject, the better.”

As for Linehan, she says she hopes that research surrounding this therapy can help identify which way of providing this therapy is most effective.

“I think the therapy in itself has a lot of good data and good research, but I think that there’s different ways to do the therapy. Like, do you implant the battery in the leg with the lead? Do you put the lead in and then you have this wireless transmitting that you do? … Is there other technology that we can advance that would help deliver the simulation for the patient.

Takeaway

The FDA has given marketing approval for a company that has released a new device for overactive bladder and urinary incontinence.

Leave a Comment

Your email address will not be published. Required fields are marked *