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Procedure

Single Arm - product does not have Communauté Européenne (CE) Mark in Europe for Overactive Bladder

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Adverse event reporting (Safety)

Performance/Effectiveness - Improvement in Quality of Life scoring (FI)

Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)

Trial Design

1Treatment groups

Experimental Treatment

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

Observational

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Axonics, Inc.Lead Sponsor

4 Previous Clinical Trials

528 Total Patients Enrolled

Prof. Bertil Blok, MD, PhDPrincipal InvestigatorErasmus Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing research study?

"Indeed, as reported on clinicaltrials.gov, this trial is actively seeking eligible participants. The initial posting of the trial occurred on December 8th, 2023 and it was most recently updated on January 4th, 2024."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Indeed, the details on clinicaltrials.gov indicate that this trial is currently in search of eligible participants. The initial posting date for the trial was December 8th, 2023 and it was last updated on January 4th, 2024. In total, there are two sites where a total of 110 patients will be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

F15 Recharge Free Axonics SNM System Clinical Study

2023. "F15 Recharge Free Axonics SNM System Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186765.

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