A new device soon could hit the market for older adults struggling with bladder control.
The technology, called the Revi System, involves a transmitter implanted in the user’s tibia and a wearable that goes around the user’s ankle and stimulates the leg in a way that helps reduce overactive bladder function.
The Revi System was cleared for the market by the US Food and Drug Administration at the end of August.
Older adults overall are the most likely age group to have an overactive bladder. The condition affects approximately 40% of men and 30% of women aged 75 or more years. Overall, 33 million Americans of any age have the condition.
The issue doesn’t arise from any one singular cause, although changes to the bladder are a normal part of the aging process, research shows.
Tech company BlueWind Medical, which produces the Revi System, calls the treatment method “neuromodulation.” Stimulating certain nerves near the ankle helps relax the bladder muscle.
In previous clinical trials, more than three-fourths of Revi System users said that their overactive bladder episodes decreased by 50%, the company’s website states.
The approach also would mean that users would not need to see physical therapists or clinicians as frequently for follow-ups, in addition to not having to use the bathroom as frequently.
The FDA recently cleared another medical device for individuals with an enlarged prostate who have difficulty using the bathroom. The approved device is a drug-coated and medicated balloon that helps widen the urinary tract.
Along similar lines, manufacturers of the drug Balversa are seeking FDA approval for it, which is aimed at those with metastatic bladder cancer.
