Urinary Incontinence, Urge
Conditions
Keywords
Sacral neuromodulation (SNM), SNM
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
Interventions
DEVICEAxonics Sacral Neuromodulation System (SNM) System
Axonics Sacral Neuromodulation System (SNM) System
Sponsors
Axonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders | 2 years | Responders are defined as patients with greater than or equal to 50% reduction in symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voids | 2 years | Measured by a bladder diary |
| ICIQ-OAB-qol | 2 years | 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. |
| Daily Number of Urgency Leaks | 2 years | The daily number of urgency leaks is measured by a bladder diary |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in CCF-FIS Score for Participants With a CCF-FIS Score ≥6 at Baseline | Baseline, 2-years | 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. |
| Participant Satisfaction for Treatment of UUI Symptoms | 2-year | 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. |
Countries
Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System | 129 |
| Total | 129 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 54 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants |
| Age, Continuous | 59.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 114 Participants |
| Region of Enrollment Netherlands | 13 participants |
| Region of Enrollment United Kingdom | 19 participants |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 129 |
| other Total, other adverse events | 20 / 129 |
| serious Total, serious adverse events | 19 / 129 |
Outcome results
Primary
Proportion of Responders
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Time frame: 2 years
Population: Completers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Proportion of Responders | 113 Participants |
Secondary
Daily Number of Urgency Leaks
The daily number of urgency leaks is measured by a bladder diary
Time frame: 2 years
Population: Completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Daily Number of Urgency Leaks | 1.0 Daily number of UUI episodes | Standard Deviation 1.7 |
Secondary
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
Population: Completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | ICIQ-OAB-qol | 87.6 score on a scale | Standard Deviation 13.9 |
Secondary
Voids
Measured by a bladder diary
Time frame: 2 years
Population: Completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Voids | 8.5 Voids | Standard Error 2.4 |
Other Pre-specified
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
Population: Completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Change in CCF-FIS Score for Participants With a CCF-FIS Score ≥6 at Baseline | Baseline | 9.3 score on a scale | Standard Deviation 3.3 |
| Treatment Group | Change in CCF-FIS Score for Participants With a CCF-FIS Score ≥6 at Baseline | 2-years | 3.7 score on a scale | Standard Deviation 3.4 |
Other Pre-specified
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
Population: Completers
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Participant Satisfaction for Treatment of UUI Symptoms | 114 Participants |