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Neuromodulation Device
Treatment group for Urge Incontinence (ARTISAN-SNM Trial)
N/A
Waitlist Available
Led By Howard Goldman, MD FACS
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.
Eligible Conditions
- Urge Incontinence
- Urge Urinary Incontinence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Responders
Secondary study objectives
Daily Number of Urgency Leaks
ICIQ-OAB-qol
Voids
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: Treatment groupExperimental Treatment1 Intervention
Urinary Urgency Incontinence
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axonics Sacral Neuromodulation System (SNM) System
2017
N/A
~130
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Who is running the clinical trial?
Axonics, Inc.Lead Sponsor
5 Previous Clinical Trials
633 Total Patients Enrolled
Axonics Modulation Technologies, Inc.Lead Sponsor
3 Previous Clinical Trials
383 Total Patients Enrolled
Howard Goldman, MD FACSPrincipal InvestigatorThe Cleveland Clinic
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