Trial Outcomes & Findings for Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (NCT NCT03327948)
NCT ID: NCT03327948
Last Updated: 2025-10-24
Results Overview
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
2 years
Results posted on
2025-10-24
Participant Flow
Participant milestones
| Measure |
Treatment Group
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
Baseline characteristics by cohort
| Measure |
Treatment Group
n=129 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=39 Participants
|
|
Age, Continuous
|
59.3 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=39 Participants
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Completers
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
Outcome measures
| Measure |
Treatment Group
n=121 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Proportion of Responders
|
113 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Completers
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.
Outcome measures
| Measure |
Treatment Group
n=121 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
ICIQ-OAB-qol
|
87.6 score on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Completers
The daily number of urgency leaks is measured by a bladder diary
Outcome measures
| Measure |
Treatment Group
n=121 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Daily Number of Urgency Leaks
|
1.0 Daily number of UUI episodes
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Completers
Measured by a bladder diary
Outcome measures
| Measure |
Treatment Group
n=121 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Voids
|
8.5 Voids
Standard Error 2.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2-yearsPopulation: Completers
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.
Outcome measures
| Measure |
Treatment Group
n=42 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
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
|
|
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 outcome
Timeframe: 2-yearPopulation: Completers
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.
Outcome measures
| Measure |
Treatment Group
n=121 Participants
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Participant Satisfaction for Treatment of UUI Symptoms
|
114 Participants
|
Adverse Events
Treatment Group
Serious events: 19 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment Group
n=129 participants at risk
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.78%
1/129 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
1/129 • 2 years
|
|
Gastrointestinal disorders
Appendicitis
|
0.78%
1/129 • 2 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.78%
1/129 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
0.78%
1/129 • 2 years
|
|
General disorders
Chest pain
|
0.78%
1/129 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.78%
1/129 • 2 years
|
|
General disorders
Influenza like illness
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Bilary sepsis
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Chlostridium difficile infection
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Cellulitis
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Sepsis
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Pneumonia
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Urosepsis
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Incision site infection
|
0.78%
1/129 • 2 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.78%
1/129 • 2 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.78%
1/129 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/129 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.78%
1/129 • 2 years
|
|
Investigations
Blood creatinine increased
|
0.78%
1/129 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.78%
1/129 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
0.78%
1/129 • 2 years
|
|
Nervous system disorders
Paresis
|
0.78%
1/129 • 2 years
|
|
Nervous system disorders
Loss of consciousness
|
0.78%
1/129 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.78%
1/129 • 2 years
|
Other adverse events
| Measure |
Treatment Group
n=129 participants at risk
Urinary Urgency Incontinence
Axonics Sacral Neuromodulation System (SNM) System: Axonics Sacral Neuromodulation System (SNM) System
|
|---|---|
|
Gastrointestinal disorders
Proctalgia
|
0.78%
1/129 • 2 years
|
|
General disorders
Implant site coldness
|
0.78%
1/129 • 2 years
|
|
General disorders
Medical device site pain
|
0.78%
1/129 • 2 years
|
|
General disorders
Medical device discomfort
|
1.6%
2/129 • 2 years
|
|
General disorders
Implant site pain
|
2.3%
3/129 • 2 years
|
|
Infections and infestations
Incision site infection
|
0.78%
1/129 • 2 years
|
|
Infections and infestations
Implant site infection
|
0.78%
1/129 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.78%
1/129 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
3/129 • 2 years
|
|
Nervous system disorders
Paraesthesia
|
0.78%
1/129 • 2 years
|
|
Product Issues
Lead dislodgement
|
0.78%
1/129 • 2 years
|
|
Product Issues
Device power source issue
|
2.3%
3/129 • 2 years
|
|
Product Issues
Device breakage
|
0.78%
1/129 • 2 years
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.78%
1/129 • 2 years
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.78%
1/129 • 2 years
|
|
Surgical and medical procedures
Medical device change
|
0.78%
1/129 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place