Axonics Trial System for Overactive Bladder and Fecal Incontinence

This trial tests a new device called the Axonics External Trial System (ETS-02) to assist individuals with overactive bladder (OAB) and/or fecal incontinence (FI). The goal is to determine if this device can improve symptoms through sacral neuromodulation, a technique that sends electrical signals to nerves to help control the bladder and bowel. Individuals diagnosed with OAB or chronic FI who believe they might benefit from this treatment may be suitable candidates. As an unphased trial, this study provides an opportunity to explore innovative treatment options for managing OAB and FI symptoms.

Research has shown that the Axonics External Trial System (ETS-02) is generally easy for patients to use. In earlier studies, 89% of individuals with overactive bladder and bowel control issues noticed significant improvement in their symptoms. Importantly, the device did not cause any serious problems. Another study found that 90% of participants experienced meaningful improvements, confirming the system's safety and effectiveness. Overall, the evidence indicates that the Axonics system is safe for people with these conditions.¹²³⁴⁵

Unlike standard treatments for overactive bladder (OAB) and fecal incontinence (FI), which often include medications or invasive surgeries, the Axonics External Trial System (ETS-02) offers a non-invasive approach. This system uses sacral neuromodulation, a technique that modulates nerve activity to improve bladder and bowel control. Researchers are excited about this treatment because it potentially provides a less invasive option with fewer side effects and can be a more patient-friendly solution for those who may not respond well to traditional therapies. Additionally, the external nature of this system means it could be a more convenient and comfortable choice for patients.

Research has shown that the Axonics System effectively treats overactive bladder (OAB) and fecal incontinence (FI). In past studies, 94% of patients expressed satisfaction with the treatment. Specifically, 93% of users experienced improvements in sudden urges to urinate, with many becoming completely dry. The Axonics System has proven effective for over two years without any serious device-related issues. Additionally, 80% of patients reported fewer urinary problems after one year. This trial will evaluate the Axonics External Trial System (ETS-02) to determine its effectiveness for patients with OAB or FI who are candidates for sacral neuromodulation. Overall, the Axonics System appears to be a promising option for managing OAB and FI symptoms.¹²⁵⁶⁷