Actively Recruiting
Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
Led by Axonics, Inc. · Updated on 2026-05-12
75
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the new Axonics External Trial System (ETS-02) in adults with overactive bladder (OAB) and/or 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 implantable neurostimulator (INS) approved for treating these conditions. Participants will use the Axonics External Trial System, which involves placing a temporary electrode wire through the S3 foramen, connected to an external pulse generator worn for a trial period of 3 to 7 days. This external system is evaluated to see if patients with OAB or FI respond to sacral neuromodulation before deciding on permanent implantation. During the study, participants are monitored for overall feasibility between days 5 and 7, and safety is assessed by recording any adverse events from day 0 to 7. The study involves keeping diaries and attending study visits to track bladder and bowel function. The total participation time includes the trial period with the external device and safety monitoring.
CONDITIONS
Brief Title
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Provides written informed consent prior to trial procedures
- Primary indication of overactive bladder (urinary urge incontinence or urinary frequency) or chronic fecal incontinence
- Considered candidates for an Axonics percutaneous nerve evaluation procedure as assessed by the physician according to product instructions for use
You will not qualify if you...
- Deemed a poor candidate by the study Investigator, including inability to complete baseline bladder or bowel diary or comply with study visits
- Planned changes to medications during the trial that could affect bladder or bowel function
- Current urinary tract mechanical obstruction such as benign prostatic enlargement or urethral stricture
- Current symptomatic urinary tract infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 to 7 days
Participants have a temporary electrode wire placed through the S3 foramen connected to an external pulse generator and wear the device for a trial period to evaluate responsiveness to sacral neuromodulation.
1 visit (in-person) to place the device and monitoring during the trial period
Trial Site Locations
Total: 1 location
1
Calvary North Adelaide Hospital/Better Bladders
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
Research Team
E
Erum Shaikh
G
Gita Ghadimi, OD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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