Summary

for people ages 21 years and up (full criteria)
at Irvine, California and other locations
study started
estimated completion
Felicia Lane, MD

Description

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.

Official Title

Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)

Keywords

Urinary Incontinence, Urge Sacral neuromodulation (SNM) SNM Urinary Incontinence Enuresis Axonics Sacral Neuromodulation System (SNM) System

Eligibility

For people ages 21 years and up

Primary Inclusion Criteria:

  1. 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.
  2. Greater than or equal to 6 months' history of UUI diagnosis
  3. 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
  4. 21 years of age and older
  5. Willing and capable of providing informed consent
  6. Capable of participating in all testing associated with this clinical investigation

Primary Exclusion Criteria:

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

Locations

  • UC Irvine Health
    Irvine California 95134 United States
  • Cleveland Clinic
    Cleveland Ohio 44106 United States

Lead Scientist

  • Felicia Lane, MD
    Health Sciences Professor, Obstetrics and Gynecology. Authored (or co-authored) 21 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Axonics Modulation Technologies, Inc.
ID
NCT03327948
Study Type
Interventional
Last Updated