Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Not Applicable

Active, not recruiting

• Conditions: Urinary Incontinence, Urge
• Interventions: Device: Axonics Sacral Neuromodulation System (SNM) System

• Registration Number: NCT03327948
• Lead Sponsor: Axonics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2017-11-21
• Primary Completion: 2019-01-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-25
• Study Completion: 2020-06-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
2. Greater than or equal to 6 months' history of UUI diagnosis
3. For male subjects only: Peak flow rate > 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume < 150 cc tested within 6 months prior to enrollment
4. 21 years of age and older
5. Willing and capable of providing informed consent
6. Capable of participating in all testing associated with this clinical investigation

Primary

Exclusion Criteria

1. Stress incontinence or mixed incontinence.
2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
3. Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Axonics Sacral Neuromodulation System (SNM) System	Urinary Urgency Incontinence

Primary Outcome Measures

Name	Time	Method
Proportion of Responders	2 years	Responders are defined as patients with greater than or equal to 50% reduction in symptoms

Secondary Outcome Measures

Name	Time	Method
ICIQ-OAB-qol	2 years	International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
Daily Number of Urgency Leaks	2 years	The daily number of urgency leaks is measured by a bladder diary
Voids	2 years	Measured by a bladder diary

Trial Locations

Locations (4)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

UCLH; 🇬🇧 London, United Kingdom

UC Irvine Health; 🇺🇸 Irvine, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States