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Neuromodulation Device

De Novo group for Sacral Neuromodulation

N/A
Waitlist Available
Research Sponsored by Axonics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.

Eligible Conditions
  • Sacral Neuromodulation
  • Urge Incontinence
  • Overactive Bladder

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the efficacy of daily cyclic stimulation of 2 hours "on" and 22 hours "off" in reducing UUI episodes by > 50% in newly implanted participants, or maintenance of efficacy in currently implanted participants with an implanted Axonics System
Secondary outcome measures
To evaluate patient satisfaction with cyclic stimulation

Trial Design

2Treatment groups
Experimental Treatment
Group I: Implanted groupExperimental Treatment1 Intervention
This group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System and are satisfied with therapy
Group II: De Novo groupExperimental Treatment1 Intervention
This group will be participants who are newly implanted with an Axonics System.

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Who is running the clinical trial?

Axonics, Inc.Lead Sponsor
4 Previous Clinical Trials
578 Total Patients Enrolled
Axonics Modulation Technologies, Inc.Lead Sponsor
3 Previous Clinical Trials
468 Total Patients Enrolled
Karen Noblett, MDStudy DirectorAxonics, Inc.
8 Previous Clinical Trials
680 Total Patients Enrolled
~21 spots leftby Jul 2025
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