Clinical trial NCT05064384: Axonics SacRal NeuromodulaTIon System RegisTRY Study
Official title: Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Retention
Urinary Urge Incontinence
Urgency-Frequency
Fecal Incontinence
Keywords: Overactive Bladder, bladder control, bowel control
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Therapy Responder Rate
timeFrame: External Trial System Evaluation
measure: Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
timeFrame: 6-months, 1-year
measure: Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
timeFrame: 6-months, 1-year
measure: Adverse Event Reporting (Safety)
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Urology Research Center
state: Arkansas
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Redwood City
country: United States
facility: Stanford Medicine
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic Urology
state: California
city: Bradenton
country: United States
facility: Manatee Medical Research Institute
state: Florida
city: Fort Myers
country: United States
facility: Urologic Solutions
state: Florida
city: N. Redington Beach
country: United States
facility: Florida Urology Partners
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Chicago
country: United States
facility: Northwestern
state: Illinois
city: New Orleans
country: United States
facility: LSU Health
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology
state: Maryland
city: Royal Oak
country: United States
facility: Comprehensive Urology
state: Michigan
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology
state: Nebraska
city: Omaha
country: United States
facility: The Urology Center PC
state: Nebraska
city: Englewood
country: United States
facility: New Jersey Urology
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Tulsa
country: United States
facility: Urologic Specialists Oklahoma
state: Oklahoma
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University
state: Pennsylvania
city: Newtown
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Axonics, Inc.
name: Karen Noblett, MD
role: STUDY_DIRECTOR
References: