Study to collect long-term clinical data for the recharge free Axonics SNM System (INS Model 4101)
| ISRCTN | ISRCTN19352412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19352412 |
| Secondary identifying numbers | 105-0118 |
- Submission date
- 23/05/2024
- Registration date
- 28/05/2024
- Last edited
- 02/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The aim of the study is to obtain long-term clinical data for the recharge-free Axonics F15 SNM System (also referred to as INS Model 4101).
Who can participate?
Adults aged 18 or older, previously diagnosed with urinary urge incontinence (UUI) with or without urinary frequency (UF) and/or chronic fecal incontinence (FI), who received the Axonics F15 SNM System device and who have baseline bladder or bowel diaries.
What does the study involve?
The study involves a retrospective chart review of all F15 implants that took place ≥1-year post-implant, at selected centers. In addition, patients who have baseline bladder or bowel diaries will be prospectively enrolled and will complete one follow-up visit. The follow-up visit entails completing a post-operative bladder or bowel diary and a patient satisfaction questionnaire.
What are the possible benefits and risks of participating?
Benefit: The study will help gather long-term data on the recharge-free Axonics F15 SNM System (also referred to as INS Model 4101).
Risks: Similar to any sacral neuromodulation device indicated for overactive bladder disease and fecal incontinence.
Where is the study run from?
Axonics, Inc. (USA)
When is the study starting and how long is it expected to run for?
December 2023 to June 2025
Who is funding the study?
Axonics, Inc. (USA)
Who is the main contact?
Dr Karen Noblett, karen.noblett@bsci.com
Contact information
Scientific
15515 Sand Canyon Avenue
Irvine
92618
United States of America
| Phone | + 1 559 250 8082 |
|---|---|
| karen.noblett@bsci.com |
Public
15515 Sand Canyon Avenue
Irvine
CA 92618
United States of America
| Phone | +1 714 686 3644 |
|---|---|
| erum.shaikh@bsci.com |
Principal Investigator
Southern Urogynecology
115 Midlands Court
West Columbia
SC 29169
United States of America
| Phone | +1 803.457.7000 |
|---|---|
| apezzella@southurogyn.com |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice, Hospital, Medical and other records |
| Study type | Other, Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participation information sheet. |
| Scientific title | F15 follow-up study |
| Study objectives | To obtain long-term clinical data for the recharge free Axonics F15 SNM System (also referred to as INS Model 4101). |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study is a data collection effort whereby data is being collected retrospectively from those patients who were implanted with the Axonics SNM F15 device who are ≥ 1-year post-implant and who have baseline bladder or bowel diaries. Please note the device has been approved by the Food and Drug Administration (FDA) in the United States and Canada in 2022 and recently approved by the Therapeutic Goods Administration (TGA) in Australia in 2024. |
| Health condition(s) or problem(s) studied | Urinary urge incontinence (UUI) with or without urinary frequency (UF) and/or chronic fecal incontinence (FI) |
| Intervention | Multicenter, prospective study comparing bladder or bowel diaries at baseline to a minimum of 1 year follow up and up to 2 years if the participant is eligible (i.e., participants implanted between March‐July 2022). Participants will be identified through a retrospective chart review of all patients at the selected sites who were implanted with the Axonics F15 SNM and who have baseline bladder or bowel diaries. Device parameters and safety data will be collected, and a patient satisfaction questionnaire will be administered at the follow‐up visit. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Axonics F15 SNM System (also referred to as INS Model 4101) |
| Primary outcome measure | Comparison from baseline to follow-up for the following: 1. ≥50% reduction in UUI episodes per day on a 3-day bladder diary OR 2. ≥50% reduction in FI episodes on a minimum of 5-day bowel diary |
| Secondary outcome measures | Comparison from baseline to follow-up for the following: 1. Complete urinary or fecal continence measured using a bladder or bowel diary 2. Device parameters (programming settings, impedance values) measured using the Clinician Programmer (CP), a tablet computer used by the clinician (or sponsor representative) to wirelessly communicate with the neurostimulator to check the device status and/or program the device 3. Procedure and/or device-related adverse events as reported in source documents by the physician and/or research staff 4. Serious adverse events (SAEs) as reported in source documents by the physician and/or research staff 5. Patient satisfaction measured using a Patient Satisfaction Questionnaire |
| Overall study start date | 18/12/2023 |
| Completion date | 25/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | Up to 80 |
| Total final enrolment | 69 |
| Key inclusion criteria | Current inclusion criteria as of 27/06/2025: 1. Aged 18 years or older 2. Provides written informed consent 3. Primary indication of UUI (with or without UF) or chronic FI who failed or could not tolerate more conservative treatments and implanted with the Axonics F15 SNM System and who have reached 1-year or greater, post-implant 4. Completion of a baseline pre-PNE 3-day bladder diary for UUI or a minimum of 5-day pre-PNE bowel diary for FI Previous inclusion criteria: 1. Aged 18 years or older 2. Provides written informed consent 3. Primary indication of UUI (with or without UF) or chronic FI who failed or could not tolerate more conservative treatments and implanted with the Axonics F15 SNM System and who have reached 1-year or greater, post-implant 4. Completion of a baseline pre-PNE 3-day bladder diary for UUI or a minimum of 7-day pre-PNE bowel diary for FI 5. English speaking |
| Key exclusion criteria | 1. Any significant medical condition that is likely to interfere with trial procedures, device operation, or likely to confound evaluation of trial endpoints (i.e., exclusion of neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder that is likely to interfere with trial procedures at the discretion of the participating physician; this may include poor understanding or compliance with trial requirements 3. A female who is breastfeeding 4. A female with a positive urine pregnancy test 5. Intradetrusor chemodenervation with OnabotulinumtoxinA (Botox) injections within 6 months prior to study follow-up visit 6. Prior history of pelvic or rectal cancer 7. Prior history of pelvic radiation |
| Date of first enrolment | 27/03/2024 |
| Date of final enrolment | 22/04/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Naples
FL 34109
United States of America
Cincinnati
Ohio 45221
United States of America
Fort Myers
FL 33908
United States of America
West Columbia
SC 29169
United States of America
Reno
NV 89511
United States of America
Fairhope
AL 36532
United States of America
Suite 115
Newtown
PA 18940
United States of America
Suite 110
San Antonio
TX 78229
United States of America
Sponsor information
Industry
15515 Sand Canyon Avenue
Irvine
CA 92618
United States of America
| Phone | +1 877 929 6642 |
|---|---|
| axn-clinicalsaf@bsci.com | |
| Website | https://www.axonics.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository called Medrio. Contact: Heather Waldeck, PhD (heather.waldeck@bsci.com) Data will be made available in the form of a published manuscript in a peer-reviewed journal. The estimated time frame is August 2025. |
Editorial Notes
02/07/2025: Total final enrolment added.
27/06/2025: The following changes were made to the study record:
1. Contact, sponsor and ethics approval details updated.
2. The recruitment end date was changed from 30/09/2024 to 22/04/2025.
3. The overall study end date was changed from 31/01/2025 to 25/06/2025.
4. The inclusion criteria were updated.
5. The study participating centres were updated to add Urology Associates, Female Pelvic Health Center, and Urology San Antonio.
13/08/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 30/08/2024 to 30/09/2024.
2. The overall study end date was changed from 31/12/2024 to 31/01/2025.
3. The intention to publish date was changed from 30/08/2025 to 30/09/2025.
24/05/2024: Trial's existence confirmed by WCG IRB
