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Recruiting
NCT07335484
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Conditions: Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Axonics, Inc.
Location: Southern Urogynecology West Columbia South Carolina
Summary
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
Eligibility 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)
Source: ClinicalTrials.gov (NCT07335484). StuddyBuddy aggregates publicly available trial information.