Aquarius Pilot Study to Evaluate the New Axonics Trial System

Axonics

Status

Not yet enrolling

Conditions

Overactive Bladder (OAB)

Fecal Incontinence (FI)

Urinary Frequency (UF)

Urinary Urge Incontinence (UUI)

Treatments

Device: Axonics External Trial System (ETS)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07335484

105-0179

Details and patient eligibility

About

Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).

Full 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).

Enrollment

75 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)