CompletedNot Applicable

Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

United States, Netherlands, United Kingdom129 participantsStarted 2017-11-21

Plain-language summary

The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
✓. Greater than or equal to 6 months' history of UUI diagnosis
✓. For male subjects only: Peak flow rate \> 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume \< 150 cc tested within 6 months prior to enrollment
✓. 21 years of age and older
✓. Willing and capable of providing informed consent
✓. Capable of participating in all testing associated with this clinical investigation

Exclusion criteria

✕. Stress incontinence or mixed incontinence.
✕. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
✕. Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
✕. A female who is breastfeeding
✕. A female with a positive urine pregnancy test

What they're measuring

Proportion of Responders

Timeframe: 2 years

Trial details

NCT IDNCT03327948

SponsorAxonics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-18

Results submitted2022-02-03

View on ClinicalTrials.gov More Urinary Incontinence, Urge trials