Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt



Status:Active, not recruiting
Conditions:Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:21 - Any
Updated:1/16/2019
Start Date:November 21, 2017
End Date:June 29, 2020

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
3
sites
1 Medical Plaza Drive
Irvine, California 95134
?
mi
from
Irvine, CA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
4-6 Minderbroedersberg
Maastricht, 6211 LK
Principal Investigator: Philip Van Kerrebroeck, MD, PhD,MMSc
?
mi
from
Maastricht,
Click here to add this to my saved trials