CompletedNot Applicable

Axonics SacRal NeuromodulaTIon System RegisTRY Study

United States272 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 range18 Years

SexALL

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)
✕. Rectomucosal prolapse or congenital anorectal malformation

What they're measuring

Therapy Responder Rate

Timeframe: External Trial System Evaluation

Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Trial details

NCT IDNCT05064384

SponsorAxonics, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-06

Results submitted2025-03-31

View on ClinicalTrials.gov More Urinary Retention trials

Who can participate

Age range18 Years

SexALL

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)
✕. Rectomucosal prolapse or congenital anorectal malformation

What they're measuring

Therapy Responder Rate

Timeframe: External Trial System Evaluation

Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year

Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline

Timeframe: 6-months, 1-year