Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
The trial system is used to determine if patients are responsive to sacral neuromodulation (SNM) prior to receiving the Axonics implantable neurostimulator (INS) which is approved for the treatment of OAB and FI. This study is evaluating the feasibility and safety of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
A temporary electrode wire is passed through the S3 foramen with or without fluoroscopic guidance. The wire is then connected to an external pulse generator (EPG) and is worn for a trial period ranging from 3-7 days.
Overall Feasibility
Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period.
Time frame: Day 5-7
Adverse Events reporting (Safety)
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
Time frame: Day 0-7
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