18 and older, any sex, with Urinary Retention or Urinary Urge Incontinence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Therapy Responder RatePrimary· External Trial System Evaluation
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.
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: Urinations per day
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
8.8
± 4.5
6-month: Urinations per day
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
7.8
± 8.0
1-year: Urinations per day
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
6.7
± 2.7
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: Urinations at night
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
3.0
± 2.4
6-month: Urinations at night
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
1.9
± 2.2
1-year: Urinations at night
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
2.0
± 2.3
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: Average degree of urgency = 0
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
2
Baseline: Average degree of urgency = 1
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
5
Baseline: Average degree of urgency = 2
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
24
Baseline: Average degree of urgency = 3
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
76
Baseline: Average degree of urgency = 4
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
44
6-month: Average degree of urgency = 0
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
15
6-month: Average degree of urgency = 1
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
23
6-month: Average degree of urgency = 2
Group
Value
95% CI
Overactive Bladder (OAB) - Urinary Frequency (UF)
47
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: FI episodes per week
Group
Value
95% CI
Fecal Incontinence (FI)
6.3
± 8.6
6-month: FI episodes per week
Group
Value
95% CI
Fecal Incontinence (FI)
1.5
± 2.7
1-year: FI episodes per week
Group
Value
95% CI
Fecal Incontinence (FI)
2.4
± 4.1
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: FI days per week
Group
Value
95% CI
Fecal Incontinence (FI)
3.8
± 2.2
6-month: FI days per week
Group
Value
95% CI
Fecal Incontinence (FI)
1.1
± 1.7
1-year: FI days per week
Group
Value
95% CI
Fecal Incontinence (FI)
1.8
± 2.3
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: Average degree of urgency = 0
Group
Value
95% CI
Fecal Incontinence (FI)
9
Baseline: Average degree of urgency = 1
Group
Value
95% CI
Fecal Incontinence (FI)
1
Baseline: Average degree of urgency = 2
Group
Value
95% CI
Fecal Incontinence (FI)
10
Baseline: Average degree of urgency = 3
Group
Value
95% CI
Fecal Incontinence (FI)
17
Baseline: Average degree of urgency = 4
Group
Value
95% CI
Fecal Incontinence (FI)
17
6-month: Average degree of urgency = 0
Group
Value
95% CI
Fecal Incontinence (FI)
15
6-month: Average degree of urgency = 1
Group
Value
95% CI
Fecal Incontinence (FI)
7
6-month: Average degree of urgency = 2
Group
Value
95% CI
Fecal Incontinence (FI)
7
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted CohortPrimary· 6-months, 1-year
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).
Baseline: Coping
Group
Value
95% CI
Overactive Bladder (OAB)
49.4
± 27.7
Baseline: Concern
Group
Value
95% CI
Overactive Bladder (OAB)
49.2
± 25.0
Baseline: Sleep
Group
Value
95% CI
Overactive Bladder (OAB)
53.4
± 29.0
Baseline: Social
Group
Value
95% CI
Overactive Bladder (OAB)
75.0
± 22.5
Baseline: HRQL
Group
Value
95% CI
Overactive Bladder (OAB)
55.3
± 22.3
6-Month: Coping
Group
Value
95% CI
Overactive Bladder (OAB)
74.8
± 26.2
6-Month: Concern
Group
Value
95% CI
Overactive Bladder (OAB)
74.8
± 25.1
6-Month: Sleep
Group
Value
95% CI
Overactive Bladder (OAB)
75.1
± 24.3
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From BaselinePrimary· 6-months, 1-year
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.
Baseline: Catheterizations per day
Group
Value
95% CI
Urinary Retention (UR)
0.8
± 1.8
6-month: Catheterizations per day
Group
Value
95% CI
Urinary Retention (UR)
0.2
± 0.8
1-year: Catheterizations per day
Group
Value
95% CI
Urinary Retention (UR)
0.2
± 0.9
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Axonics, Inc.
Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05064384.