Aquarius Pilot Study to Evaluate the New Axonics Trial System

Part of paid clinical trials in West Columbia, South Carolina.

Sponsor
Axonics, Inc.
Study ID
NCT07335484
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axonics External Trial System (ETS) — DEVICE
    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.

Study Details

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

Key Dates

First listed
Jan 13, 2026
Start date
Apr 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Feasibility [ Time Frame: Day 5-7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southern UrogynecologyWest ColumbiaSouth Carolina29169
Tina McGready
Andrea Pezzella, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Columbia, SC

By research site
Southern Urogynecology· West Columbia, SC

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