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Aquarius Pilot Study to Evaluate the New Axonics Trial System

Axonics, Inc. · NCT07335484

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
75
US sites recruiting
3
Study start
April 30, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Axonics External Trial System (ETS)

Conditions: Urinary Urge Incontinence (UUI); Urinary Frequency (UF); Fecal Incontinence (FI); Overactive Bladder (OAB)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • University of Birmingham, Alabama

    Birmingham, AL 35294

    Site contact: Alisha Hitt

  • Atrium Health - Navicent

    Macon, GA 31201

    Site contact: Jennifer Crawford, PhD

  • Southern Urogynecology

    West Columbia, SC 29169

    Site contact: Tina McGready

Study contacts (from the official record)

  • Erum Shaikh · 657.626.4310 · Erum.Shaikh@bsci.com
  • Gita Ghadimi, OD · 949-981-4366 · Gita.Ghadimi@bsci.com
All women’s health studies in Alabama →
Aquarius Pilot Study to Evaluate the New Axonics Trial System (NCT07335484) | Bored Studies