Axonics SacRal NeuromodulaTIon System RegisTRY Study (ARTISTRY)

September 2, 2025 updated by: Axonics, Inc.

Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study will be a prospective, multi-center, single-arm, post-market registry study. Participant outcomes will be compared to their baseline, with participants serving as their own control.

The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72210
        • Arkansas Urology Research Center
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • Redwood City, California, United States, 94063
        • Stanford Medicine
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic Urology
    • Florida
      • Bradenton, Florida, United States, 34205
        • Manatee Medical Research Institute
      • Fort Myers, Florida, United States, 33908
        • Urologic Solutions
      • North Redington Beach, Florida, United States, 33708
        • Florida Urology Partners
      • St. Petersburg, Florida, United States, 33710
        • Pinellas Urology
      • Tampa, Florida, United States, 33606
        • Florida Urology Partners
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Chesapeake Urology
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Comprehensive Urology
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Adult Pediatric Urology & Urogynecology
      • Omaha, Nebraska, United States, 68114
        • The Urology Center PC
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • New Jersey Urology
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0558
        • University of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Urologic Specialists Oklahoma
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Institute for Female Pelvic Medicine and Reconstructive Surgery
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University
      • Newtown, Pennsylvania, United States, 33606
        • The Female Pelvic Health Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Southern Urogynecology
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Center for Pelvic Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who are scheduled to undergo an Axonics Trial or Axonics System will be considered candidates for the study and will be recruited from each Investigator's patient population.

Description

Inclusion Criteria:

  1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant
  2. Willing and capable of providing informed consent
  3. Capable of participating in all testing associated with this clinical investigation

Exclusion Criteria:

For all indications:

  1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
  2. Any psychiatric or personality disorder at the discretion of the study physician
  3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
  4. A female who is breastfeeding

  5. A female with a positive urine pregnancy test

    For OAB & UR:

  6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)

  7. Current symptomatic urinary tract infection (UTI)

    For FI only:

  8. Rectomucosal prolapse or congenital anorectal malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapy Responder Rate
Time Frame: External Trial System Evaluation
Percentage of participants who were determined as responders by the treating physician when using the External Trial Stimulator and who received the Axonics System. At least a 50% reduction in symptoms is considered standard in relevant literature for response rate therefore decision for determination of responder was left to PI discretion.
External Trial System Evaluation
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.
6-months, 1-year
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.
6-months, 1-year
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the degree of urgency leaks experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
6-months, 1-year
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the degree of urgency experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
6-months, 1-year
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.
6-months, 1-year
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the degree of urgency experienced.
6-months, 1-year
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Time Frame: 6-months, 1-year
Change in ICIQ-OABqol scores at follow-up compared to baseline for implanted participants. Questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is considered a minimally important difference (MID).
6-months, 1-year
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
Time Frame: 6-months, 1-year
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UR diagnosis at baseline were asked about the number of catheterizations required per day.
6-months, 1-year
Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
Time Frame: 6-months, 1-year
Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.
6-months, 1-year
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
Time Frame: 6-months, 1-year
Change in FIQL score compared to baseline for implanted participants. Fecal Incontinence Quality of Life (FIQL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
6-months, 1-year
Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
Time Frame: 6-months, 1-year
Change in O'Leary Sant score at follow-up compared to baseline for all implanted participants. The O'Leary Sant is a validated questionnaire designed to provide data on painful bladder and urinary frequency symptoms. Symptom and Problem Index scores are calculated based on responses to two sets of 4 questions with higher scores representing more symptoms/problems. A total score from 0 - 40 is also calculated based on all responses. At follow-up, an O'Leary Sant was only collected for those participants an O'Leary Sant score ≥ 6 at baseline.
6-months, 1-year
Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
Time Frame: 6-months, 1-year
Change in AUA-SI score at follow-up compared to baseline for Urinary Retention participants who were implanted with the device. The AUA-SI (American Urological Association Symptom Index) is a questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) in men, with scores ranging from 0 to 35, categorizing symptoms as mild (0-7), moderate (8-19), or severe (20-35). A higher score indicates more severe UR symptoms and a score of greater than 8 indicates moderate to severe UR symptoms.
6-months, 1-year
Adverse Event Reporting (Safety)
Time Frame: 1-year
The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axonics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karen Noblett, MD, Axonics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 105-0076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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