A new device to treat incontinence is being developed by Peter Sayet at Precision Medical Devices Inc., reports the Orlando Sentinel.

Incontinence is the term used when people pass urine unintentionally. It is a common condition thought to affect around 40 million people. Incontinence can be a symptom of many different conditions, including Alzheimer’s, paralysis, spinal cord injury, and spina bifida. Women also often become incontinent following childbirth if their pelvic muscles and nerves are injured. There are several different types of incontinence with different levels of severity. These include stress incontinence, when urine leaks out when the bladder in under pressure from things like laughing or coughing, and total incontinence, where the bladder is unable to store any urine resulting in frequent or constant leaking.

Treatments for incontinence depend on the severity of the condition, but include dietary changes, pelvic floor exercises, bladder training, medications, products such as absorbent pads and handheld urinals, and, in some cases, surgery. Surgery can be used to strengthen bladder muscles, expand the bladder, reduce pressure on the bladder, or implant devices that influence muscles around the bladder. However, the current surgical options tend to have downsides. A device used for men called a urethra valve requires two to three hours of surgery to insert. Furthermore, it cannot be used for many patients with Alzheimer’s because they may need a caregiver to operate it, and this isn’t possible. The most common surgical option for women is the transvaginal mesh, but this has an extremely high failure rate with 1 out of every 30 female patients having it removed or revised after experiencing problems with it. In the US, over 50,000 women are suing the device manufacturers through a class-action lawsuit.

The new device being developed by Precision Medical Devices is hoped to overcome these issues with the surgical options. It is called the Flow Control Device and is an implanted valve that surrounds the urethra. A wireless fob or phone app can be used to open or close the valve, to start or stop urine from passing. This will make the device accessible to all patients, who can either control it themselves or have a caregiver work it remotely. Furthermore, the surgery will only last 35 minutes.

The Flow Control Device has been under development for twenty years. During that time, it has been implanted into twenty-four dogs successfully, and as a result has extended the dog’s lifespan. It is planned to become commercially available for dog use by the end of the year. Following this, the company hopes to carry out a clinical trial in people, and, by 2020, make the device available to all patients with incontinence.

If shown to be effective in humans and approved by the US Food and Drug Administration this device would provide patients with another surgical treatment option for incontinence that overcomes some of the difficulties associated with current techniques. The inventor of the device, Peter Sayet, says that once it is brought to market he plans to develop more versions of it, including a larger valve for patients who had colostomies and as a result lost control of their waste functions.

What are your thoughts on surgical treatments for incontinence? Share your stories, thoughts, and hopes, with the Patient Worthy community!