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F15 Recharge Free Axonics SNM System Clinical Study

NCT06186765 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-05-12

No results posted yet for this study

Summary

Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

Conditions

  • Urinary Urge Incontinence (UUI)
  • Urinary Frequency (UF)
  • Fecal Incontinence (FI)

Interventions

DEVICE

Axonics SNM System (Model 4101)

Safety and performance/effectiveness assessment of the recharge free Axonics SNM System (Model 4101 in participants with overactive bladder (OAB) or fecal incontinence (FI).

Sponsors & Collaborators

  • Axonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Bertil Blok, MD, PhD · Erasmus Medical Center

  • 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
2023-12-08
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT06186765 on ClinicalTrials.gov