Aquarius Pilot Study to Evaluate the New Axonics Trial System

Purpose

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

Conditions

  • Urinary Urge Incontinence (UUI)
  • Urinary Frequency (UF)
  • Fecal Incontinence (FI)
  • Overactive Bladder (OAB)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure 		External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation.
  • Device: Axonics 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.
    Other names:
    • Basic or Advanced Trial

More Details

Status
Recruiting
Sponsor
Axonics, Inc.

Study Contact

Erum Shaikh
657.626.4310
Erum.Shaikh@bsci.com

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).