Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Overview

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.

Full Title of Study: “Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 18, 2019

Interventions

  • Device: Axonics Sacral Neuromodulation System (SNM) System
    • Axonics Sacral Neuromodulation System (SNM) System

Arms, Groups and Cohorts

  • Experimental: Treatment group
    • Urinary Urgency Incontinence

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Responders
    • Time Frame: 6 month
    • Responders are defined as patients with greater than or equal to 50% reduction in symptoms

Secondary Measures

  • ICIQ-OAB-qol
    • Time Frame: 6 month
    • International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
  • Number of leaks
    • Time Frame: 6 month
  • Number of voids
    • Time Frame: 6 month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Axonics Modulation Technologies, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Howard Goldman, MD FACS, Principal Investigator, The Cleveland Clinic
    • Felicia Lane, MD, Principal Investigator, UC Irvine Health

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