NCT03327948

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2020

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 3, 2024

Completed
Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

October 27, 2017

Results QC Date

February 3, 2022

Last Update Submit

October 10, 2025

Conditions

Urinary Incontinence, Urge

Keywords

Sacral neuromodulation (SNM)SNM

Outcome Measures

Primary Outcomes (1)

  • Proportion of Responders

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

    2 years

Secondary Outcomes (3)

  • ICIQ-OAB-qol

    2 years

  • Daily Number of Urgency Leaks

    2 years

  • Voids

    2 years

Other Outcomes (2)

  • Change in CCF-FIS Score for Participants With a CCF-FIS Score ≥6 at Baseline

    Baseline, 2-years

  • Participant Satisfaction for Treatment of UUI Symptoms

    2-year

Study Arms (1)

Treatment group

EXPERIMENTAL

Urinary Urgency Incontinence

Device: Axonics Sacral Neuromodulation System (SNM) System

Interventions

Axonics Sacral Neuromodulation System (SNM) SystemDEVICE

Axonics Sacral Neuromodulation System (SNM) System

Treatment group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age and older
  • Willing and capable of providing informed consent
  • Capable of participating in all testing associated with this clinical investigation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UC Irvine Health

Irvine, California, 95134, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

UCLH

London, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Gita Ghadimi
Organization
Axonics, Inc.
gita.ghadimi@axonics.com
9497516412

Study Officials

  • Howard Goldman, MD FACS

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Felicia Lane, MD

    UC Irvine Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 1, 2017

Study Start

November 21, 2017

Primary Completion

January 18, 2019

Study Completion

June 29, 2020

Last Updated

October 24, 2025

Results First Posted

September 3, 2024

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)US(2)NL(1)