Each year, 500.000 women undergo mesh surgery due to severe stress incontinence and no better available options. This is despite the risks and the fact that mesh surgery may not work at all. The risk benefit ratio is so bad that in 2017 New Zealand and in July 2018, UK NHS suspended mesh surgery. The number of mesh surgery related law suits is over 100.000 in the USA.
A much better solution is urgently needed!
We have developed and clinically tested a unique medical device, with we expect will help thousands of women in their everyday life.
Our solution is a single-use, very soft, silicone tube, that the user herself inserts in the urethra each morning. The tube stays in place all day, and has an inner valve, which restores her control over bladder voiding. The tube is discarded the tube in the evening, before going to bed.
Three groups of users have tested this device in three series of clinical trials at the Copenhagen University Hospital. Doctors conclude, that our device is safe and immediately efficient. As the device is both comfortable (our clinical trials even include comfort testing while riding a bicycle, which is important here in Scandinavia) and easy to use, we have a high user approval.
In Q1 2019, we will start the important long term study, in which we will see how the daily life is improved and quantify user and market acceptance.
Our design is protected by to patent families, granted in EU and China, pending in USA.