Sacral neuromodulation (SNM) is a guideline-recommended treatment for faecal incontinence (FI), overactive bladder (OAB), and non-obstructive urinary retention.(1-3) The objective of this trial is to assess the safety and efficacy of a new recharge-free SNM device for the treatment of FI and OAB. Primary endpoint results in FI patients are reported here.

Single-arm, multi-center, prospective clinical trial conducted in Europe (pivotal trial) and the USA (post-market) of chronic FI patients who had failed conservative management. Intraoperative and post-implant data were prospectively collected to evaluate safety and efficacy of the Axonics F15 SNM system (Boston Scientific, Marlborough, MA). This system comprises an implantable neurostimulator, a tined lead and non-implantable components for device operation. Primary endpoints were improvement at 3 months post-implant compared to baseline on the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS; one-sided t-test, alpha=0.025, performance goal of 2-point improvement) and adverse events (AEs). Secondary endpoints included Fecal Incontinence Quality of Life (FIQOL) domain score improvement at 3 months post implant compared to baseline (one-sided t-test, alpha=0.025, performance goal of 0 points). Patients are followed for 12 months, anticipated to end in 2026.

Of 67 total FI patients enrolled at 11 sites, 57 were successfully implanted and followed through 3 months to assess the primary endpoint.

Of the implanted patients  52 [91%] were female, 5 [9%] male, mean [±SD] age 66.9 [±11.2] years, mean [±SD] BMI 29.0 [±5.4] kg/m2 and mean [±SD] time from FI diagnosis to enrollment was 7.9 [±11.0] years.  

Mean score improvement at 3 months was -6.3 ± 4.7 (95% CI -7.6, -5.1;  p <0.001) for CCF-FIS (Figure 1, Panel A). Of these 57 patients, fifty (88%) experienced symptom relief, Forty-nine (86%) had ≥2 point improvement in CCF-FIS total score, and twenty-five (44%) experienced ≥50% score reduction compared to baseline (Figure 1, Panel B).

Additionally, all FIQOL domain scores (n=57) also showed a positive improvement at 3 months (1.2 ± 0.8; 95% CI: 1.0, 1.4, p < 0.001) (Figure 1, Panel C). 

To date, no unanticipated adverse device effects have been reported. Device-related only events were reported in 6 (9.0%) patients, with 1 event being a serious AE. Procedure-related only events were reported in 2 (3.0%) patients and events related to both the device and procedure were reported in 3 (4.5%) patients. Two patients required revision surgery for non-serious AEs (sensation of the lead in the lower back). No deaths have been reported. 

According to the study questionnaire completed by 57 patients at 3 months, >73% of respondents indicated a ≥50% improvement in bowel symptoms. Over 84% of patients were satisfied with SNM for their FI symptoms.  Ninety-five percent of patients would undergo the procedure again and ≥98% would recommend the SNM system to a family member or friend.

This study provides robust data that the Axonics F15 recharge-free SNM system has a proven short-term safety and effectiveness profile in chronic FI patients. The majority of patients (86%) reported on the CCF-FIS a clinically important reduction of 2 points or more.

These data add to the evidence that the Axonics SNM is an effective treatment for FI, particularly with regard to symptom reduction and patient satisfaction.

Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. Published online April 23, 2024. doi:10.1097/JU.0000000000003985.
Ginsberg DA, Boone TB, Cameron AP, Gousse A, Kaufman MR, Keays E, Kennelly MJ, Lemack GE, Rovner ES, Souter LH, Yang CC, Kraus SR. The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Treatment and Follow-up. J Urol. 2021 Nov;206(5):1106-1113. doi: 10.1097/JU.0000000000002239.
Bordeianou LG, Thorsen AJ, Keller DS, Hawkins AT, Messick C, Oliveira L, Feingold DL, Lightner AL, Paquette IM. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Fecal Incontinence. Dis Colon Rectum. 2023 May 1;66(5):647-661. doi: 10.1097/DCR.0000000000002776.

Continence 19S (2026) 102641
DOI: 10.1016/j.cont.2026.102641