Study of the New Axonics External Trial System to Test Responsiveness to Sacral Neuromodulation for Overactive Bladder and Fecal Incontinence in Adults

What this Trial Is About

Researchers are evaluating the new Axonics External Trial System ETS-02 in adults with overactive bladder OAB andor fecal incontinence FI. The study aims to assess the feasibility and safety of this external trial system, which helps determine if patients respond to sacral neuromodulation SNM before receiving the Axonics implantable neurostimulator approved for treating these conditions. The Axonics External Trial System involves placing a temporary electrode wire through the S3 foramen, possibly with fluoroscopic guidance, connected to an external pulse generator worn for 3 to 7 days. This trial system is used to evaluate patient responsiveness to SNM prior to implanting the permanent neurostimulator device. Participants provide consent and undergo trial procedures including the placement and use of the external trial system for up to 7 days. Researchers monitor feasibility and safety by assessing outcomes such as overall feasibility between days 5 and 7 and adverse events from day 0 to 7. The total study period extends until December 2026, with ongoing safety monitoring during the trial period.

Aquarius Pilot Study to Evaluate the New Axonics Trial System