Axonics SacRal NeuromodulaTIon System RegisTRY Study (NCT05064384) | Clinical Trial Compass
CompletedNot Applicable
Axonics SacRal NeuromodulaTIon System RegisTRY Study
United States, Canada272 participantsStarted 2020-11-30
Plain-language summary
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Willing and capable of providing informed consent
. Capable of participating in all testing associated with this clinical investigation
Exclusion criteria
. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
. Any psychiatric or personality disorder at the discretion of the study physician
. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
. A female who is breastfeeding
. A female with a positive urine pregnancy test
. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
. Current symptomatic urinary tract infection (UTI)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Therapy Responder Rate
Timeframe: External Trial System Evaluation
2
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
Timeframe: 6-months, 1-year
3
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
Timeframe: 6-months, 1-year
4
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Timeframe: 6-months, 1-year
5
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Timeframe: 6-months, 1-year
6
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
Timeframe: 6-months, 1-year
7
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline