N/A
Completed N=272
Axonics SacRal NeuromodulaTIon System RegisTRY Study
Urinary Retention · Urinary Urge Incontinence · Urgency-Frequency · Fecal Incontinence
Source: ClinicalTrials.gov NCT05064384 ↗
Enrolled (actual)
272
Serious AEs
5.5%
Results posted
Jun 2025
Primary outcomePrimary: Therapy Responder Rate — 206 Participants
Summary
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapy Responder Rate |
206 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline |
2.2; 1.1; 1.0 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline |
3.0; 1.9; 2.0 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline |
7; 6; 21; 90; 58; 21 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline |
2; 5; 24; 76; 44; 15 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline |
3.8; 1.1; 1.8 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline |
9; 1; 10; 17; 17; 15 | — |
| PRIMARY Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort |
49.4; 49.2; 53.4; 75.0; 55.3; 74.8 | — |
| PRIMARY Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline |
0.8; 0.2; 0.2 | — |
| PRIMARY Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline |
10.7; 6.3; 6.8 | — |
| PRIMARY Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort |
2.7; 2.1; 3.0; 2.2; 3.4; 2.9 | — |
| PRIMARY Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort |
20.7; 11.7; 11.8 | — |
| PRIMARY Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort |
18.7; 10.4; 10.3 | — |
| PRIMARY Adverse Event Reporting (Safety) |
0; 2; 0; 13 | — |
Eligibility Criteria
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
For all indications:
- 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
For OAB & UR:
- Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
- Current symptomatic urinary tract infection (UTI)
For FI only:
- Rectomucosal prolapse or congenital anorectal malformation
Data sourced from ClinicalTrials.gov (NCT05064384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.