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

• Sponsor: Axonics Modulation Technologies, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03327948
• Collaborator: (none)
• Enrollment: 145
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 31.2
• Patients Per Site: 36.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Urge	Device: Axonics Sacral Neuromodulation System (SNM) System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 145 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
• Actual Study Start Date: Nov 21, 2017
• Actual Primary Completion Date: Jan 18, 2019
• Anticipated Study Completion Date: Jun 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Urinary Urgency Incontinence	Device: Axonics Sacral Neuromodulation System (SNM) System; Axonics Sacral Neuromodulation System (SNM) System

Outcome Measures

Primary Outcome Measures

1. Proportion of Responders [6 month]

   Responders are defined as patients with greater than or equal to 50% reduction in symptoms

Secondary Outcome Measures

1. ICIQ-OAB-qol [6 month]

   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.

2. Number of leaks [6 month]

3. Number of voids [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Irvine Health	Irvine	California	United States	95134
2	Cleveland Clinic	Cleveland	Ohio	United States	44106
3	Maastricht University Medical Center	Maastricht		Netherlands
4	UCLH	London		United Kingdom

Sponsors and Collaborators

• Axonics Modulation Technologies, Inc.

Investigators

• Principal Investigator: Howard Goldman, MD FACS, The Cleveland Clinic
• Principal Investigator: Felicia Lane, MD, UC Irvine Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Axonics Modulation Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT03327948
• Other Study ID Numbers: 105-0050
• First Posted: Nov 1, 2017
• Last Update Posted: Apr 25, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Axonics Modulation Technologies, Inc.: Sacral neuromodulation (SNM); SNM
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Incontinence, Urge

Study Results

No Results Posted as of Apr 25, 2019