An interventional study of Axonics Sacral Neuromodulation System (SNM) System in Urinary Incontinence, Urge, sponsored by Axonics, Inc.. Completed at 4 sites in 3 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-10-24.
Sponsored by Axonics, Inc. · Not applicable, Interventional, and Treatment
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.
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
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Urinary Urgency Incontinence
Device: Axonics Sacral Neuromodulation System (SNM) System
Axonics Sacral Neuromodulation System (SNM) System
Proportion of Responders
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Time frame: 2 years
ICIQ-OAB-qol
International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
Time frame: 2 years
Daily Number of Urgency Leaks
The daily number of urgency leaks is measured by a bladder diary
Time frame: 2 years
Voids
Measured by a bladder diary
Time frame: 2 years
Change in CCF-FIS Score for Participants With a CCF-FIS Score ≥6 at Baseline
Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.
Time frame: Baseline, 2-years
Participant Satisfaction for Treatment of UUI Symptoms
The subject satisfaction questionnaire was designed to provide information on subjective satisfaction with r-SNM therapy and the recharging experience. Participants indicated satisfaction with r-SNM therapy for treatment of their UUI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied". Results are presented as the number of participants who reported "Very, moderately, or slightly satisfied" with r-SNM therapy for treatment of their UUI symptoms.
Time frame: 2-year
| Milestone | Treatment Group |
|---|---|
| Started | 129 |
| Completed | 126 |
| Not completed | 3 |
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
| Participants | Treatment Group |
|---|---|
| Proportion of Responders | 113 |
International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
| score on a scale | Treatment Group |
|---|---|
| ICIQ-OAB-qol | 87.6 ± 13.9 |
The daily number of urgency leaks is measured by a bladder diary
| Daily number of UUI episodes | Treatment Group |
|---|---|
| Daily Number of Urgency Leaks | 1.0 ± 1.7 |
Measured by a bladder diary
| Voids | Treatment Group |
|---|---|
| Voids | 8.5 ± 2.4 |
Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.
| score on a scale | Fecal Incontinence |
|---|---|
| Baseline | 9.3 ± 3.3 |
| 2-years | 3.7 ± 3.4 |
The subject satisfaction questionnaire was designed to provide information on subjective satisfaction with r-SNM therapy and the recharging experience. Participants indicated satisfaction with r-SNM therapy for treatment of their UUI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied". Results are presented as the number of participants who reported "Very, moderately, or slightly satisfied" with r-SNM therapy for treatment of their UUI symptoms.
| Participants | Treatment Group |
|---|---|
| Participant Satisfaction for Treatment of UUI Symptoms | 114 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 1/129 (0.8%) | 19/129 (14.7%) | 20/129 (15.5%) |
| Event | Treatment Group |
|---|---|
| FallInjury, poisoning and procedural complications | 2/129 |
| Atrial fibrillationCardiac disorders | 1/129 |
| Abdominal painGastrointestinal disorders | 1/129 |
| AppendicitisGastrointestinal disorders | 1/129 |
| Large intestine perforationGastrointestinal disorders | 1/129 |
| ColitisGastrointestinal disorders | 1/129 |
| Chest painGeneral disorders | 1/129 |
| Non-cardiac chest painGeneral disorders | 1/129 |
| Influenza like illnessGeneral disorders | 1/129 |
| Bilary sepsisInfections and infestations | 1/129 |
| Event | Treatment Group |
|---|---|
| Implant site painGeneral disorders | 3/129 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/129 |
| Device power source issueProduct Issues | 3/129 |
| Medical device discomfortGeneral disorders | 2/129 |
| ProctalgiaGastrointestinal disorders | 1/129 |
| Implant site coldnessGeneral disorders | 1/129 |
| Medical device site painGeneral disorders | 1/129 |
| Incision site infectionInfections and infestations | 1/129 |
| Implant site infectionInfections and infestations | 1/129 |
| Groin painMusculoskeletal and connective tissue disorders | 1/129 |
| Age, Categorical(Participants) | Treatment Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 75 |
| >=65 years | 54 |
| Age, Continuous(years) | Treatment Group |
|---|---|
| Mean | 59.3 (21 to 86) |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 127 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 122 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Treatment Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 114 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(participants) | Treatment Group |
|---|---|
| Netherlands | 13 |
| United States | 97 |
| United Kingdom | 19 |
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Axonics, Inc.