Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Urinary Incontinence, Urge Clinical Trial

— ARTISAN-SNM  

Official title:

Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03327948
• Other study ID #: 105-0050
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: June 29, 2020

Study information

• Verified date: April 2019
• Source: Axonics Modulation Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: June 29, 2020
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Primary 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• Axonics Sacral Neuromodulation System (SNM) System
Axonics Sacral Neuromodulation System (SNM) System

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht
United Kingdom	UCLH	London
United States	Cleveland Clinic	Cleveland	Ohio
United States	UC Irvine Health	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Axonics Modulation Technologies, Inc.

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Responders	Responders are defined as patients with greater than or equal to 50% reduction in symptoms	6 month
Secondary	ICIQ-OAB-qol	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.	6 month
Secondary	Number of leaks		6 month
Secondary	Number of voids		6 month