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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327948
Recruitment Status : Active, not recruiting
First Posted : November 1, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Axonics Modulation Technologies, Inc.

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) in patients who have failed or could not tolerate more conservative treatments.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Urge Device: Axonics Sacral Neuromodulation System (SNM) System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : January 18, 2019
Estimated Study Completion Date : June 29, 2020

Arm Intervention/treatment
Experimental: Treatment group
Urinary Urgency Incontinence
Device: Axonics Sacral Neuromodulation System (SNM) System
Axonics Sacral Neuromodulation System (SNM) System




Primary Outcome Measures :
  1. Proportion of Responders [ Time Frame: 6 month ]
    Responders are defined as patients with greater than or equal to 50% reduction in symptoms


Secondary Outcome Measures :
  1. 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.

  2. Number of leaks [ Time Frame: 6 month ]
  3. Number of voids [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327948


Locations
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United States, California
UC Irvine Health
Irvine, California, United States, 95134
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
United Kingdom
UCLH
London, United Kingdom
Sponsors and Collaborators
Axonics Modulation Technologies, Inc.
Investigators
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Principal Investigator: Howard Goldman, MD FACS The Cleveland Clinic
Principal Investigator: Felicia Lane, MD UC Irvine Health

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Responsible Party: Axonics Modulation Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03327948     History of Changes
Other Study ID Numbers: 105-0050
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Axonics Modulation Technologies, Inc.:
Sacral neuromodulation (SNM)
SNM
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms