Fecal Incontinence (FI), Overactive Bladder (OAB), Urinary Frequency (UF), Urinary Urge Incontinence (UUI)
Conditions
Keywords
Peripheral nerve evaluation, External trial system, Pilot study
Brief summary
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Detailed description
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).
Interventions
DEVICEAxonics External Trial System (ETS)
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.
Sponsors
Axonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Provides written informed consent prior to trial procedures * Primary indication of OAB (UUI/UF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU
Exclusion criteria
* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits * Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function * Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture) * Current symptomatic urinary tract infection (UTI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Feasibility | Day 5-7 | Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period. |
| Adverse Events reporting (Safety) | Day 0-7 | Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA). |
Countries
Australia, United States
Contacts
CONTACTErum Shaikh
CONTACTGita Ghadimi, OD
PRINCIPAL_INVESTIGATORAilsa Wilson Edwards, MD
Calvary North Adelaide Hospital
Outcome results
None listed