Stress urinary incontinence (SUI) affects an estimated 90 million Europeans and 40 millions Americans, primarily women. It occurs when the pressure in the bladder exceeds that of the muscle (the sphincter) around the urethra, caused by activities involving high intra-abdominal pressure, like coughing, laughing and exercising. It is an ignored public health problem, as it is often a taboo. Yet, SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. In most severe cases, it turns people lives into a living hell, especially since existing therapies are unsatisfactory.
For men, manual artificial urinary sphincters (AUS) have been on the market since the 1970s, with little or no improvement since then. These archaic manual devices require the scrotum to be manipulated for each urination, sometimes with the help of a relative for dependent people. It's humiliating. These devices are associated with a significant rate of revision and explantation, notably because of manually manipulated implantable components, which are fragile and fail, and because the constant pressure exerted on the urethra often leads to erosion and atrophy. Unfortunately, in these cases, the surgeon is obliged to remove the device, and the patient returns to the hell of incontinence for good.
For women, the most commonly used solution is mesh slings, initially developed for cases of prolapse. This solution leaves 15% of women incontinent, with potential serious adverse effects, to such an extent that they are the subject of over 100,000 lawsuits in the USA. The UK and Australia have already banned the product. Manual artificial urinary sphincters are not a viable solution for women. The pump is placed in the labia majora, and handling it involves urinating on the hands. In the US, Boston Scientific's "gold standard" (AMS 800™) is not approved for women. In Europe, fewer than 500 are implanted per year. But these implants demonstrate the demand from women suffering from severe stress-induced urinary incontinence, who are so desperate that they will accept such an inconvenient device. Severely incontinent people urgently need a safe and decent solution.
Based on this damning observation, UroMems was born with the aim to restore normal life and dignity to patients suffering from severe stress urinary incontinence. The strategy was to study the devices on the market, understand their weaknesses and shortcomings, and design a device that solves all of them and fully meets the expectations of male and female patients and their doctors. After 5 years of fundamental research and 6 years of technological development, the result is an outstanding medical device, UroActive™, which has been successfully implanted in humans since 2022. Its features are exceptional in terms of functionality, safety, performance and robustness.
UroActive™ is:
• Adapted to both men and women
• Easy to use for patients with a simple remote control (no more manual manipulation of the genitals)
• Safer. Several safety functions protect the patient and the pressure on the urethra can be adjusted at the minimum needed (depending on patient’s activity) to avoid leaks, with the aim to prevent the urethra from erosion.
• Easy to operate for healthcare professionals and fully personalized for the patient.
• Easy to implant, through a less invasive surgery than current devices (fewer components to implant, implantation kit) and thus potentially less prone to peri-operational infections.
• Connected. The surgeon can collect functioning and physiological data which are extremely useful for therapy personalization and patient follow-up.
UroActive™ device will restore the quality of life, dignity and self-esteem of the millions of men and women worldwide suffering from severe SUI, with a decent, effective and safe therapy.
