Recruiting

Axonics ETS-02

Sponsor:

Axonics, Inc.

Code:

NCT07335484

Conditions

Urinary Urge Incontinence (UUI)

Urinary Frequency (UF)

Fecal Incontinence (FI)

Overactive Bladder (OAB)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axonics External Trial System (ETS)

Study Details

Brief summary:

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)

Study ID

NCT07335484

Start date

Apr 30, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Overall Feasibility [ Time Frame: Day 5-7 ]
  • Adverse Events reporting (Safety) [ Time Frame: Day 0-7 ]

Central Contacts and Locations

Central contacts

Erum Shaikh

657.626.4310Erum.Shaikh@bsci.com

Gita Ghadimi, OD

949-981-4366Gita.Ghadimi@bsci.com

Locations

Southern Urogynecology

Recruiting

West Columbia, South Carolina, United States, 29169

Principal Investigator:

Andrea Pezzella, MD

More Information

Sponsor

Axonics, Inc.

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Peripheral nerve evaluation
  • External trial system
  • Pilot study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Axonics, Inc. on 2026-09-14.