Status:
COMPLETED
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
Lead Sponsor:
Axonics, Inc.
Conditions:
Urinary Incontinence, Urge
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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)...
Detailed Description
The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axon...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03327948
Start Date
November 21 2017
End Date
June 29 2020
Last Update
October 24 2025
Active Locations (4)
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1
UC Irvine Health
Irvine, California, United States, 95134
2
Cleveland Clinic
Cleveland, Ohio, United States, 44106
3
Maastricht University Medical Center
Maastricht, Netherlands
4
UCLH
London, United Kingdom