Aquarius Pilot Study to Evaluate the New Axonics Trial System
NCT ID: NCT07335484
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2026-02-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Pacific Clinical Research Group
OTHER
Axonics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ailsa Wilson Edwards, MD
Role: PRINCIPAL_INVESTIGATOR
Calvary North Adelaide Hospital
Central Contacts
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Other Identifiers
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105-0179
Identifier Type: -
Identifier Source: org_study_id
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