First Female Receives Robotic-Assisted Sphincter Device in France

In a landmark medical procedure, a French woman has become the first female recipient of an automated artificial sphincter device, a novel solution for stress urinary incontinence (SUI). The device, dubbed UroActive, is the brainchild of Grenoble-based tech firm UroMems.

The recipient of the device, who wished to remain anonymous, expressed her joy at being able to return to routine daily activities without the constant worry of SUI. The UroActive device employs a MyoElectroMechanical System that encircles the urethral duct and adapts according to the patient’s activity level.

UroActive’s unique selling point lies in its innovative integration of electronics and smart digital systems. This bionic platform utilizes collected patient data to formulate a personalized treatment algorithm, thus tailoring the device to each patient’s specific needs.

SUI is a condition wherein the bladder pressure surpasses that of the muscle (the sphincter) surrounding the urethra, leading to involuntary urine leakage during activities that exert high intra-abdominal pressure such as coughing, laughing, or exercising. While women are more susceptible to SUI, men can also be affected.

The pioneering robotic-assisted procedure was carried out at La Pitié-Salpêtrière University Hospital in Paris, with the approval of The National Agency for the Safety of Medicines and Health Products (ANSM). The results derived from this clinical study will significantly influence the design and execution of UroMems’ pivotal clinical trials in Europe and the United States.

The concept of UroActive was born out of a discussion between biomedical engineer Hamid Lamraoui and urologist Pierre Mozer around 15 years ago. Lamraoui recounted Mozer’s description of his patients’ silent suffering due to severe SUI and the limited treatment options available.

Traditional treatments for mild SUI include pelvic floor physical therapy and bulking agents. However, moderate to severe cases have been limited to mesh sling or a manually-operated artificial sphincter. The latter is a dated device conceived in the 1970s, with its last iteration emerging about 40 years ago.

In response to this challenge, Lamraoui and Mozer teamed up with Stéphane Lavallée in 2011 to establish UroMems. Their goal was to create a device that would surpass current solutions in terms of safety, performance, patient experience, and surgeon convenience.

In their quest to design an optimal device, the UroMems team scrutinized the existing mechanical artificial sphincter to understand its strengths and weaknesses from both surgeons’ and patients’ perspectives. This device comprises three parts: a urethral cuff controlling urine flow; an abdominal balloon holding fluid; and a pump that relaxes the cuff by transferring fluid from the cuff to the balloon.

The team’s vision was to simplify the patient experience by eliminating the need for manual operation of the cuff through skin contact. This led them to discard both the pump and balloon system and replace it with an automated control unit resembling a pacemaker.

This control unit houses a bionic platform that uses embedded smart digital systems and robotics to generate a personalized treatment algorithm based on patient data. The core technology is what UroMems refers to as a MyoElectroMechanical System.

Developing this system presented significant challenges due to the need for hermetic sealing, full biocompatibility, and enhanced efficiency compared to the predicate device. Lamraoui credits their success to patience and regular collaboration with physicians.

Lamraoui emphasizes that their progress thus far is largely attributable to their close working relationship with physicians. Regular meetings with surgeons have proven invaluable in defining user requirements and gaining feedback on development. This collaborative approach between physicians and engineers is key to tackling complex medical device projects, according to Lamraoui.