Clinical trial NCT06186765: F15 Recharge Free Axonics SNM System Clinical Study
Official title: Prospective, Non-randomized, Multicenter Clinical Evaluation of the Recharge Free Axonics SNM System (Model 4101)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Urge Incontinence (UUI)
Urinary Frequency (UF)
Fecal Incontinence (FI)
Lead sponsor: Axonics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.

Detailed description: A clinical evaluation to comply with new European Medical Device Regulations (EU MDR) guidelines. Multicenter, prospective, non-randomized, single arm study for OAB and/or FI to assess the safety and performance of the Food and Drug Administration (FDA) approved Axonics recharge free sacral neuromodulation (SNM) System, model 4101. The product is currently marketed under the name F15 in the United States.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Primary indication of overactive bladder (OAB) (urinary urgency incontinence (UUI)/ urinary frequency (UF)) or fecal incontinence (FI) who are not candidates for, or who have failed conservative treatment
3. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year.

Exclusion Criteria:

1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (exclusion of neurological conditions such as multiple sclerosis)
2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
3. Previously underwent an external sacral neuromodulation (SNM) trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
5. A female who is breastfeeding
6. A female with a positive urine pregnancy test

Primary outcomes:
measure: Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
timeFrame: 3 months
measure: Performance/Effectiveness - Improvement in Fecal Incontinence Survey
timeFrame: 3 months
measure: Performance/Effectiveness - Improvement in Quality of Life scoring (FI)
timeFrame: 3 months
measure: Adverse event reporting (Safety)
timeFrame: 3 months
Secondary outcomes:
measure: Performance/Effectiveness - Improvement in Quality of Life scoring (OAB)
timeFrame: 1 year
measure: Performance/Effectiveness - Improvement in Fecal Incontinence Survey
timeFrame: 1 year
measure: Performance/Effectiveness - Improvement in Quality of Life Survey (FI)
timeFrame: 1 year
measure: Adverse event reporting (Safety)
timeFrame: 1 year
Other outcomes:
Locations:
city: Waterford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Bradenton
country: United States
facility: Manatee Medical Research Institute
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute of Research
state: Florida
city: Naples
country: United States
facility: Florida Bladder Institute
state: Florida
city: Macon
country: United States
facility: Atrium Health
state: Georgia
city: Coon Rapids
country: United States
facility: Minnesota Urology
state: Minnesota
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Myrtle Beach
country: United States
facility: Southern Shores Urogynecology
state: South Carolina
city: Houston
country: United States
facility: Houston Colon
state: Texas
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Urological Institute
city: London
country: United Kingdom
facility: University College London Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Prof. Bertil Blok, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: