Trial Outcomes & Findings for Axonics SacRal NeuromodulaTIon System RegisTRY Study (NCT NCT05064384)
NCT ID: NCT05064384
Last Updated: 2025-09-22
Results Overview
Percentage of participants who were determined as responders by the treating physician when using the External Trial Stimulator and who received the Axonics System. At least a 50% reduction in symptoms is considered standard in relevant literature for response rate therefore decision for determination of responder was left to PI discretion.
Recruitment status
COMPLETED
Target enrollment
272 participants
Primary outcome timeframe
External Trial System Evaluation
Results posted on
2025-09-22
Participant Flow
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the Participant Flow are not able to be stratified into each type of diagnosis.
Participant milestones
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who underwent an Axonics External Trial System (ETS) trial surgery and/or full system implant surgery of the Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Screening
STARTED
|
272
|
|
Screening
COMPLETED
|
268
|
|
Screening
NOT COMPLETED
|
4
|
|
Safety
STARTED
|
268
|
|
Safety
COMPLETED
|
253
|
|
Safety
NOT COMPLETED
|
15
|
|
Treatment
STARTED
|
253
|
|
Treatment
COMPLETED
|
250
|
|
Treatment
NOT COMPLETED
|
3
|
|
Implant
STARTED
|
250
|
|
Implant
COMPLETED
|
218
|
|
Implant
NOT COMPLETED
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Axonics SacRal NeuromodulaTIon System RegisTRY Study
Baseline characteristics by cohort
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=250 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
217 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Latino or Hispanic
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Declined to state
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
250 Participants
n=5 Participants
|
|
BMI
< 18.5 kg/m2
|
2 participants
n=5 Participants
|
|
BMI
18.5-24.9 kg/m2
|
42 participants
n=5 Participants
|
|
BMI
25.0-29.9 kg/m2
|
79 participants
n=5 Participants
|
|
BMI
30.0-34.9 kg/m2
|
60 participants
n=5 Participants
|
|
BMI
35.0-39.9 kg/m2
|
28 participants
n=5 Participants
|
|
BMI
>=40.0 kg/m2
|
25 participants
n=5 Participants
|
|
BMI
Unknown
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: External Trial System EvaluationPercentage of participants who were determined as responders by the treating physician when using the External Trial Stimulator and who received the Axonics System. At least a 50% reduction in symptoms is considered standard in relevant literature for response rate therefore decision for determination of responder was left to PI discretion.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=218 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Therapy Responder Rate
|
206 Participants
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=182 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
Baseline: Urgency leaks per day
|
4.8 leaks per day
Standard Deviation 6.1
|
|
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
6-month: Urgency leaks per day
|
2.4 leaks per day
Standard Deviation 2.7
|
|
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
1-year: Urgency leaks per day
|
2.4 leaks per day
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the number of urgency leaks experienced.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=182 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
Baseline: Urgency leaks after bed
|
2.2 leaks after bed
Standard Deviation 2.8
|
|
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
6-month: Urgency leaks after bed
|
1.1 leaks after bed
Standard Deviation 2.0
|
|
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
1-year: Urgency leaks after bed
|
1.0 leaks after bed
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=151 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
Baseline: Urinations per day
|
8.8 urinations per day
Standard Deviation 4.5
|
|
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
6-month: Urinations per day
|
7.8 urinations per day
Standard Deviation 8.0
|
|
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
1-year: Urinations per day
|
6.7 urinations per day
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the number of urinations they experienced per day and at night.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=151 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
Baseline: Urinations at night
|
3.0 urinations at night
Standard Deviation 2.4
|
|
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
6-month: Urinations at night
|
1.9 urinations at night
Standard Deviation 2.2
|
|
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
1-year: Urinations at night
|
2.0 urinations at night
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Number of participants experiencing degree of urgency on a scale of 0-4, 0 meaning no urgency and 4 meaning severe urgency. Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UUI diagnosis at baseline were asked about the degree of urgency leaks experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=182 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 0
|
7 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 1
|
6 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 2
|
21 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 3
|
90 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 4
|
58 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 0
|
21 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 1
|
27 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 2
|
48 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 3
|
36 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 4
|
20 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 0
|
21 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 1
|
28 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 2
|
47 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 3
|
23 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 4
|
13 Participants
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Number of participants experiencing degree of urgency on a scale of 0-4, 0 meaning no urgency and 4 meaning severe urgency. Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UF diagnosis at baseline were asked about the degree of urgency experienced using the following scale: 0=no urgency; 1=mild urgency; 2= moderate urgency; 3=strong urgency and 4=severe urgency.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=151 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 0
|
2 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 1
|
5 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 2
|
24 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 3
|
76 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 4
|
44 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 0
|
15 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 1
|
23 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 2
|
47 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 3
|
27 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 4
|
13 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 0
|
14 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 1
|
25 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 2
|
38 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 3
|
26 Participants
|
|
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 4
|
13 Participants
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=54 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
Baseline: FI episodes per week
|
6.3 episodes per week
Standard Deviation 8.6
|
|
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
6-month: FI episodes per week
|
1.5 episodes per week
Standard Deviation 2.7
|
|
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
1-year: FI episodes per week
|
2.4 episodes per week
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the number of FI episodes experienced.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=54 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
Baseline: FI days per week
|
3.8 days per week
Standard Deviation 2.2
|
|
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
6-month: FI days per week
|
1.1 days per week
Standard Deviation 1.7
|
|
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
1-year: FI days per week
|
1.8 days per week
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Number of participants experiencing degree of urgency on a scale of 0-4, 0 meaning no urgency and 4 meaning severe urgency. Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a FI diagnosis at baseline were asked about the degree of urgency experienced.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=54 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 3
|
10 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 0
|
9 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 1
|
1 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 2
|
10 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 3
|
17 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
Baseline: Average degree of urgency = 4
|
17 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 0
|
15 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 1
|
7 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 2
|
7 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
6-month: Average degree of urgency = 4
|
5 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 0
|
13 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 1
|
5 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 2
|
8 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 3
|
3 Participants
|
|
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
1-year: Average degree of urgency = 4
|
6 Participants
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in ICIQ-OABqol scores at follow-up compared to baseline for implanted participants. Questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is considered a minimally important difference (MID).
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=199 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Baseline: Coping
|
49.4 score on a scale
Standard Deviation 27.7
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Baseline: Concern
|
49.2 score on a scale
Standard Deviation 25.0
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Baseline: Sleep
|
53.4 score on a scale
Standard Deviation 29.0
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Baseline: Social
|
75.0 score on a scale
Standard Deviation 22.5
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
Baseline: HRQL
|
55.3 score on a scale
Standard Deviation 22.3
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
6-Month: Coping
|
74.8 score on a scale
Standard Deviation 26.2
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
6-Month: Concern
|
74.8 score on a scale
Standard Deviation 25.1
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
6-Month: Sleep
|
75.1 score on a scale
Standard Deviation 24.3
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
6-Month: Social
|
89.1 score on a scale
Standard Deviation 18.9
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
6-Month: HRQL
|
77.7 score on a scale
Standard Deviation 21.2
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
1-Year: Coping
|
74.3 score on a scale
Standard Deviation 27.5
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
1-Year: Concern
|
73.6 score on a scale
Standard Deviation 25.6
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
1-Year Sleep
|
77.1 score on a scale
Standard Deviation 23.0
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
1-Year Social
|
89.0 score on a scale
Standard Deviation 18.7
|
|
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
1-Year: HRQL
|
77.9 score on a scale
Standard Deviation 21.4
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Overall number of participants analyzed are those implanted patients who were diagnosed with Urinary Retention (UR). Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in indication-specific patient symptoms from baseline for all implanted patients by Patient Symptom Questionnaire results. The patient symptoms questionnaire assesses participants' diagnosis-specific symptoms at baseline and at follow-up. Participants who reported a UR diagnosis at baseline were asked about the number of catheterizations required per day.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=50 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
Baseline: Catheterizations per day
|
0.8 catheterizations per day
Standard Deviation 1.8
|
|
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
6-month: Catheterizations per day
|
0.2 catheterizations per day
Standard Deviation 0.8
|
|
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
1-year: Catheterizations per day
|
0.2 catheterizations per day
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: A CCF-FIS was collected for all participants at baseline. At follow-up, a CCF-FIS was only collected for those participants with a FI diagnosis or a CCF-FIS score ≥ 6 at baseline. Difference in number of participants across timepoints account for study exits that occurred during follow-up.
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 |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=81 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
Baseline CCF-FIS Score
|
10.7 score on a scale
Standard Deviation 4.1
|
|
Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
6-Month: CCF-FIS Score
|
6.3 score on a scale
Standard Deviation 4.5
|
|
Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
1-Year CCF-FIS Score
|
6.8 score on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Overall number of participants analyzed are those implanted patients who were diagnosed with Fecal Incontinence (FI) and/or scored \>=6 on CCF-FIS. Overall participants analyzed includes those participants that completed the CCF-FIS \& FIQL (data point found in Table 9. Assessment Compliance, Week 1-4).
Change in FIQL score compared to baseline for implanted participants. Fecal Incontinence Quality of Life (FIQL) includes four different subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5, with 1 indicating lower functional status of qualify of life.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=81 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
Baseline: Lifestyle
|
2.7 score on a scale
Standard Deviation 1.0
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
Baseline: Coping/Behavior
|
2.1 score on a scale
Standard Deviation 0.8
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
Baseline: Depression/Self Perception
|
3.0 score on a scale
Standard Deviation 0.9
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
Baseline: Embarrassment
|
2.2 score on a scale
Standard Deviation 0.9
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
6-Month: Lifestyle
|
3.4 score on a scale
Standard Deviation 0.8
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
6-Month: Coping/Behavior
|
2.9 score on a scale
Standard Deviation 0.9
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
6-Month: Depression/Self Perception
|
3.6 score on a scale
Standard Deviation 0.8
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
6-Month: Embarrassment
|
3.0 score on a scale
Standard Deviation 1.0
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
1-Year: Lifestyle
|
3.1 score on a scale
Standard Deviation 1.0
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
1-Year: Coping/Behavior
|
2.7 score on a scale
Standard Deviation 0.8
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
1-Year: Depression/Self Perception
|
3.7 score on a scale
Standard Deviation 0.7
|
|
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
1-Year: Embarrassment
|
2.7 score on a scale
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in O'Leary Sant score at follow-up compared to baseline for all implanted participants. The O'Leary Sant is a validated questionnaire designed to provide data on painful bladder and urinary frequency symptoms. Symptom and Problem Index scores are calculated based on responses to two sets of 4 questions with higher scores representing more symptoms/problems. A total score from 0 - 40 is also calculated based on all responses. At follow-up, an O'Leary Sant was only collected for those participants an O'Leary Sant score ≥ 6 at baseline.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=151 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
Baseline: Total Score
|
20.7 score on a scale
Standard Deviation 6.8
|
|
Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
6-Month: Total Score
|
11.7 score on a scale
Standard Deviation 8.2
|
|
Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
1-Year Total Score
|
11.8 score on a scale
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: 6-months, 1-yearPopulation: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
Change in AUA-SI score at follow-up compared to baseline for Urinary Retention participants who were implanted with the device. The AUA-SI (American Urological Association Symptom Index) is a questionnaire used to assess the severity of lower urinary tract symptoms (LUTS) in men, with scores ranging from 0 to 35, categorizing symptoms as mild (0-7), moderate (8-19), or severe (20-35). A higher score indicates more severe UR symptoms and a score of greater than 8 indicates moderate to severe UR symptoms.
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=50 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
Baseline: AUA-SI Score
|
18.7 score on a scale
Standard Deviation 8.6
|
|
Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
6-Month: AUA-SI Score
|
10.4 score on a scale
Standard Deviation 8.1
|
|
Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
1-Year: AUA-SI Score
|
10.3 score on a scale
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: 1-yearThe number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).
Outcome measures
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=253 Participants
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS).
|
|---|---|
|
Adverse Event Reporting (Safety)
Device-related SAEs
|
0 number of events
|
|
Adverse Event Reporting (Safety)
Procedure-related SAEs
|
2 number of events
|
|
Adverse Event Reporting (Safety)
Device- and Procedure-related SAEs
|
0 number of events
|
|
Adverse Event Reporting (Safety)
SAEs (not device- or procedure-related)
|
13 number of events
|
Adverse Events
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Serious events: 14 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=253 participants at risk
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS). This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the adverse event numbers are not able to be stratified into each type of diagnosis.
|
|---|---|
|
Nervous system disorders
Transient Ischemic Attack
|
0.79%
2/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Nervous system disorders
Acute Encephalopathy
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Blood and lymphatic system disorders
Orthostatic Hypotension
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Nervous system disorders
Syncope
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Musculoskeletal and connective tissue disorders
Pain at INS Site
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Infections and infestations
Urinary Tract Infection
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Blood and lymphatic system disorders
Hypernatremia
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Cardiac disorders
Chest Pain
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of Hypokalemic Periodic Paralysis
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Infections and infestations
Septic Shock
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Nervous system disorders
Cerebral Vascular Accident
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Infections and infestations
Urosepsis
|
0.40%
1/253 • Number of events 2 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
Other adverse events
| Measure |
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
n=253 participants at risk
Patients diagnosed with overactive bladder (OAB), urinary retention (UR), and/or fecal incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS). This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the adverse event numbers are not able to be stratified into each type of diagnosis.
|
|---|---|
|
Nervous system disorders
Uncomfortable/Undesirable Stimulation
|
2.0%
5/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Infections and infestations
Implant Site Infection
|
1.2%
3/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Skin and subcutaneous tissue disorders
Pain at Lead Site
|
0.79%
2/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Skin and subcutaneous tissue disorders
Pain at INS Site
|
0.79%
2/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Skin and subcutaneous tissue disorders
Implant Site Induration
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Product Issues
Lead Erosion
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Product Issues
Lead Migration
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Nervous system disorders
Loss of Efficacy
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Musculoskeletal and connective tissue disorders
Pain at Contralateral Hip
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Musculoskeletal and connective tissue disorders
Worsening of Chronic Back Pain
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
|
Renal and urinary disorders
Worsening of Urinary Symptoms
|
0.40%
1/253 • 1 year
This non-randomized study recruited participants who may have had an overlap of their diagnoses, some of which the overlap could have been as a result of their responses to certain questionnaires. For example, participants who scored ≥6 on the CCF-FIS questionnaires at baseline would be included in the FI cohort analysis while their primary indication may be UUI. Because of this, the numbers in the adverse event table are not able to be stratified into each type of diagnosis.
|
Additional Information
Karen Noblett, MD, Chief Medical Officer
Boston Scientific
Phone: 559-250-8082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place