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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Axonics, Inc.
Study ID
NCT06789406
Status
Recruiting
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Conditions

  • Overactive Bladder (OAB)
  • Urinary Frequency (UF)
  • Urinary Urge Incontinence (UUI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axonics SNM System INS Model 5101 (R20) — DEVICE
    Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.

Study Details

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.

Key Dates

Start date
Sep 18, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Oct 31, 2031

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Overactive Bladder
    Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.

Primary Outcome Measure

Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB) [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Rowena Shi
Kimberly Kenton, MD (PRINCIPAL_INVESTIGATOR)
University of MissouriColumbiaMissouri65211
Kaycee Mackanos
Raymond Foster, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Chicago· Chicago, ILUniversity of Missouri· Columbia, MO

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