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Trial record 1 of 1 for:    NCT03327948
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Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)

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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.

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 1, 2017
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE November 21, 2017
Actual Primary Completion Date January 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Proportion of Responders [ Time Frame: 6 month ]
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03327948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
Official Title  ICMJE Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence, Urge
Intervention  ICMJE Device: Axonics Sacral Neuromodulation System (SNM) System
Axonics Sacral Neuromodulation System (SNM) System
Study Arms  ICMJE Experimental: Treatment group
Urinary Urgency Incontinence
Intervention: Device: Axonics Sacral Neuromodulation System (SNM) System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2017)
145
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 29, 2020
Actual Primary Completion Date January 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327948
Other Study ID Numbers  ICMJE 105-0050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Axonics Modulation Technologies, Inc.
Study Sponsor  ICMJE Axonics Modulation Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Howard Goldman, MD FACS The Cleveland Clinic
Principal Investigator: Felicia Lane, MD UC Irvine Health
PRS Account Axonics Modulation Technologies, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP