Clinical trial NCT03327948: Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
Official title: Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Urge
Keywords: Sacral neuromodulation (SNM)
SNM
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 129
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axonics SNM System for the treatment of UUI symptoms. Primary outcome was improvement in UUI episodes on a 3-day bladder diary. Secondary outcomes included quality of life using the ICIQ-OABqol questionnaire, patient satisfaction, and bowel symptoms captured using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Participants were followed out to 2 years and data was reported at 6 months, 1 year and 2 years

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Responders
timeFrame: 2 years
Secondary outcomes:
measure: ICIQ-OAB-qol
timeFrame: 2 years
measure: Daily Number of Urgency Leaks
timeFrame: 2 years
measure: Voids
timeFrame: 2 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine Health
state: California
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: London
country: United Kingdom
facility: UCLH
Study officials:
affiliation: The Cleveland Clinic
name: Howard Goldman, MD FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Irvine Health
name: Felicia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References: