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PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised at 1 of 6 sites
  2. Study completion moved earlier from Oct 2031 to Dec 2027v18
  3. Study sites: 5 to 6v17
  4. Re-verified, no change to tracked fieldsv16
  5. Site contacts updated at 1 of 5 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 4 to 5v14
  2. Study title expanded, about 5 wordsv13
  3. 5 versions Re-verified since Dec 1, 2025, no change to tracked fieldsv8-v12
  4. Study sites: 2 to 4v7
  5. Study sites: 1 to 2
    • Start date changed from estimate of Sep 2025 to Sep 18, 2025
    v6
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2026 to Jan 2027
    • Study sites: 0 to 1
    • Study completion date: Mar 2030 to Oct 2031
    v5
  7. Start date: Jul 2025 to Sep 2025v4
  8. Re-verified, no change to tracked fieldsv3
  9. Start date: Mar 2025 to Jul 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Axonics, Inc.
5 trials monitored
See 1 trial at risk
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Trial Details
NCT Number NCT06789406
Lead Sponsor Axonics, Inc.
Conditions
(from sponsor)		 Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)
Related terms Urinary Bladder, Overactive, Urinary Incontinence, Urge
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov