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

NCT06789406 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Axonics SNM System INS Model 5101 (R20)

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.

Sponsors & Collaborators

  • Axonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mahreen Pakzad, MD · University College London Hospitals

  • Gita Ghadimi, OD · Boston Scientific Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2027-01-31
Completion
2031-10-31
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789406 on ClinicalTrials.gov