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Procedure

Axonics SNM System for Overactive Bladder and Fecal Incontinence

N/A
Recruiting
Led By Prof. Bertil Blok, MD, PhD
Research Sponsored by Axonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is evaluating the effectiveness of the Axonics recharge free SNM System in patients with overactive bladder and/or fecal incontinence.

Who is the study for?
This trial is for adults over 18 with overactive bladder (OAB) or fecal incontinence (FI) who haven't had success with standard treatments. Participants must be able to give informed consent and commit to follow-up assessments for up to a year.
What is being tested?
The study is testing the Axonics SNM System, a device designed for people with OAB or FI. It's a single-arm evaluation, meaning all participants receive the same treatment without comparison to another group or placebo.
What are the potential side effects?
Potential side effects of using the Axonics SNM System may include discomfort at the implant site, infection risk, lead movement, technical problems with the device, and possible changes in bowel or urinary functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have overactive bladder or fecal incontinence and treatments haven't worked for me.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse event reporting (Safety)
Performance/Effectiveness - Improvement in Quality of Life scoring (FI)
Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm - product does not have Communauté Européenne (CE) Mark in EuropeExperimental Treatment1 Intervention
Observational

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Who is running the clinical trial?

Axonics, Inc.Lead Sponsor
5 Previous Clinical Trials
632 Total Patients Enrolled
Prof. Bertil Blok, MD, PhDPrincipal InvestigatorErasmus Medical Center
~19 spots leftby Mar 2025
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