Aquarius Pilot Study to Evaluate the New Axonics Trial System

NCT07335484 | Not Yet Recruiting FDA Device

• 1 other identifier: 105-0179
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Peripheral nerve evaluation; External trial system; Pilot study

Outcome Measures

Primary Outcomes (2)

• Overall Feasibility

  Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period.

  Day 5-7

• Adverse Events reporting (Safety)

  Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).

  Day 0-7

Study Arms (1)

Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure

EXPERIMENTAL

External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation.

Device: Axonics External Trial System (ETS)

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.

Also known as: Basic or Advanced Trial

Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Axonics, Inc.: lead

MeSH Terms

Conditions

Urinary Incontinence, Urge; Fecal Incontinence; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urinary Bladder Diseases

Study Officials

• Ailsa Wilson Edwards, MD

  Calvary North Adelaide Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erum Shaikh

CONTACT

657.626.4310; Erum.Shaikh@bsci.com

Gita Ghadimi, OD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share