N/A
Completed N=129
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
Urinary Incontinence, Urge
Source: ClinicalTrials.gov NCT03327948 ↗
Enrolled (actual)
129
Serious AEs
14.7%
Results posted
Sep 2024
Primary outcomePrimary: Proportion of Responders — 113 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Responders |
113 | — |
| SECONDARY ICIQ-OAB-qol |
87.6 | — |
| SECONDARY Daily Number of Urgency Leaks |
1.0 | — |
| SECONDARY Voids |
8.5 | — |
Eligibility Criteria
Primary 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
Primary 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
Data sourced from ClinicalTrials.gov (NCT03327948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.