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

Primary Purpose

Urinary Incontinence, Urge

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Axonics Sacral Neuromodulation System (SNM) System
Sponsored by
Axonics Modulation Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Sacral neuromodulation (SNM), SNM

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Irvine Health
  • Cleveland Clinic
  • Maastricht University Medical Center
  • UCLH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Urinary Urgency Incontinence

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Number of leaks
Number of voids

Full Information

First Posted
October 27, 2017
Last Updated
April 23, 2019
Sponsor
Axonics Modulation Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03327948
Brief Title
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
Acronym
ARTISAN-SNM
Official Title
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
June 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axonics Modulation Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Urge
Keywords
Sacral neuromodulation (SNM), SNM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Urinary Urgency Incontinence
Intervention Type
Device
Intervention Name(s)
Axonics Sacral Neuromodulation System (SNM) System
Intervention Description
Axonics Sacral Neuromodulation System (SNM) System
Primary Outcome Measure Information:
Title
Proportion of Responders
Description
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Time Frame
6 month
Secondary Outcome Measure Information:
Title
ICIQ-OAB-qol
Description
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.
Time Frame
6 month
Title
Number of leaks
Time Frame
6 month
Title
Number of voids
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria: 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. Greater than or equal to 6 months' history of UUI diagnosis 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 21 years of age and older Willing and capable of providing informed consent Capable of participating in all testing associated with this clinical investigation Primary Exclusion Criteria: Stress incontinence or mixed incontinence. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines A female who is breastfeeding A female with a positive urine pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Goldman, MD FACS
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felicia Lane, MD
Organizational Affiliation
UC Irvine Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine Health
City
Irvine
State/Province
California
ZIP/Postal Code
95134
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Facility Name
UCLH
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

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