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CompletedNCT05064384ARTISTRYUpdated Sep 22, 2025Results posted

Axonics SacRal NeuromodulaTIon System RegisTRY Study

An observational study in Urinary Retention, Urinary Urge Incontinence and Urgency-Frequency, sponsored by Axonics, Inc.. Completed at 27 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Axonics, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
272
Ages
18 Years and older
Sex
All
01

Study summary

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

Read the detailed description

The study will be a prospective, multi-center, single-arm, post-market registry study. Participant outcomes will be compared to their baseline, with participants serving as their own control.

The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.

02

Conditions studied

  • Urinary Retention
  • Urinary Urge Incontinence
  • Urgency-Frequency
  • Fecal Incontinence

Keywords

  • Overactive Bladder, bladder control, bowel control
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants who are scheduled to undergo an Axonics Trial or Axonics System will be considered candidates for the study and will be recruited from each Investigator's patient population.

Inclusion criteria

  1. Patients scheduled to be trialed with the Axonics External Trial System (ETS), or patients scheduled to receive an Axonics Implantable neurostimulator (INS) or Axonics FS implant
  2. Willing and capable of providing informed consent
  3. Capable of participating in all testing associated with this clinical investigation

Exclusion criteria

Exclusion Criteria:

For all indications:

  1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints
  2. Any psychiatric or personality disorder at the discretion of the study physician
  3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
  4. A female who is breastfeeding

  5. A female with a positive urine pregnancy test

    For OAB \& UR:

  6. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)

  7. Current symptomatic urinary tract infection (UTI)

    For FI only:

  8. Rectomucosal prolapse or congenital anorectal malformation
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
272 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Therapy Responder Rate

    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.

    Time frame: External Trial System Evaluation

  2. Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  3. Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  4. Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  5. Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  6. Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  7. Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  8. Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort

    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).

    Time frame: 6-months, 1-year

  9. Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline

    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.

    Time frame: 6-months, 1-year

  10. Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or 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: 6-months, 1-year

  11. Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort

    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.

    Time frame: 6-months, 1-year

  12. Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort

    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.

    Time frame: 6-months, 1-year

  13. Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort

    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.

    Time frame: 6-months, 1-year

  14. Adverse Event Reporting (Safety)

    The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).

    Time frame: 1-year

06

Results

Posted Jun 5, 2025

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.

Screening
Participant flow — Screening
MilestoneOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Started272
Completed268
Not completed4
Safety
Participant flow — Safety
MilestoneOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Started268
Completed253
Not completed15
Treatment
Participant flow — Treatment
MilestoneOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Started253
Completed250
Not completed3
Implant
Participant flow — Implant
MilestoneOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Started250
Completed218
Not completed32

Outcome measures

PrimaryTherapy Responder Rate

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.

Time frame:
External Trial System Evaluation
Reported as:
Count of participants · Participants
Therapy Responder Rate
ParticipantsOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Therapy Responder Rate206
PrimaryPerformance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · leaks per day
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
leaks per dayOveractive Bladder (OAB) - Urinary Urge Incontinence (UUI)
Baseline: Urgency leaks per day4.8 ± 6.1
6-month: Urgency leaks per day2.4 ± 2.7
1-year: Urgency leaks per day2.4 ± 3.6
PrimaryPerformance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · leaks after bed
Performance/Effectiveness - Improvement of Patient UUI Symptoms in the Implanted Cohort From Baseline
leaks after bedOveractive Bladder (OAB) - Urinary Urge Incontinence (UUI)
Baseline: Urgency leaks after bed2.2 ± 2.8
6-month: Urgency leaks after bed1.1 ± 2.0
1-year: Urgency leaks after bed1.0 ± 2.0
PrimaryPerformance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · urinations per day
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
urinations per dayOveractive Bladder (OAB) - Urinary Frequency (UF)
Baseline: Urinations per day8.8 ± 4.5
6-month: Urinations per day7.8 ± 8.0
1-year: Urinations per day6.7 ± 2.7
PrimaryPerformance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · urinations at night
Performance/Effectiveness - Improvement of Patient UF Symptoms in the Implanted Cohort From Baseline
urinations at nightOveractive Bladder (OAB) - Urinary Frequency (UF)
Baseline: Urinations at night3.0 ± 2.4
6-month: Urinations at night1.9 ± 2.2
1-year: Urinations at night2.0 ± 2.3
PrimaryPerformance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Count of participants · Participants
Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline
ParticipantsOveractive Bladder (OAB) - Urinary Urge Incontinence (UUI)
Baseline: Average degree of urgency = 07
Baseline: Average degree of urgency = 16
Baseline: Average degree of urgency = 221
Baseline: Average degree of urgency = 390
Baseline: Average degree of urgency = 458
6-month: Average degree of urgency = 021
6-month: Average degree of urgency = 127
6-month: Average degree of urgency = 248
6-month: Average degree of urgency = 336
6-month: Average degree of urgency = 420
1-year: Average degree of urgency = 021
1-year: Average degree of urgency = 128
1-year: Average degree of urgency = 247
1-year: Average degree of urgency = 323
1-year: Average degree of urgency = 413
PrimaryPerformance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Count of participants · Participants
Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline
ParticipantsOveractive Bladder (OAB) - Urinary Frequency (UF)
Baseline: Average degree of urgency = 02
Baseline: Average degree of urgency = 15
Baseline: Average degree of urgency = 224
Baseline: Average degree of urgency = 376
Baseline: Average degree of urgency = 444
6-month: Average degree of urgency = 015
6-month: Average degree of urgency = 123
6-month: Average degree of urgency = 247
6-month: Average degree of urgency = 327
6-month: Average degree of urgency = 413
1-year: Average degree of urgency = 014
1-year: Average degree of urgency = 125
1-year: Average degree of urgency = 238
1-year: Average degree of urgency = 326
1-year: Average degree of urgency = 413
PrimaryPerformance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · episodes per week
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
episodes per weekFecal Incontinence (FI)
Baseline: FI episodes per week6.3 ± 8.6
6-month: FI episodes per week1.5 ± 2.7
1-year: FI episodes per week2.4 ± 4.1
PrimaryPerformance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · days per week
Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline
days per weekFecal Incontinence (FI)
Baseline: FI days per week3.8 ± 2.2
6-month: FI days per week1.1 ± 1.7
1-year: FI days per week1.8 ± 2.3
PrimaryPerformance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Count of participants · Participants
Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline
ParticipantsFecal Incontinence (FI)
Baseline: Average degree of urgency = 09
Baseline: Average degree of urgency = 11
Baseline: Average degree of urgency = 210
Baseline: Average degree of urgency = 317
Baseline: Average degree of urgency = 417
6-month: Average degree of urgency = 015
6-month: Average degree of urgency = 17
6-month: Average degree of urgency = 27
6-month: Average degree of urgency = 310
6-month: Average degree of urgency = 45
1-year: Average degree of urgency = 013
1-year: Average degree of urgency = 15
1-year: Average degree of urgency = 28
1-year: Average degree of urgency = 33
1-year: Average degree of urgency = 46
PrimaryPerformance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort

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).

Time frame:
6-months, 1-year
Reported as:
Mean · score on a scale
Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort
score on a scaleOveractive Bladder (OAB)
Baseline: Coping49.4 ± 27.7
Baseline: Concern49.2 ± 25.0
Baseline: Sleep53.4 ± 29.0
Baseline: Social75.0 ± 22.5
Baseline: HRQL55.3 ± 22.3
6-Month: Coping74.8 ± 26.2
6-Month: Concern74.8 ± 25.1
6-Month: Sleep75.1 ± 24.3
6-Month: Social89.1 ± 18.9
6-Month: HRQL77.7 ± 21.2
1-Year: Coping74.3 ± 27.5
1-Year: Concern73.6 ± 25.6
1-Year Sleep77.1 ± 23.0
1-Year Social89.0 ± 18.7
1-Year: HRQL77.9 ± 21.4
PrimaryPerformance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline

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.

Time frame:
6-months, 1-year
Reported as:
Mean · catheterizations per day
Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline
catheterizations per dayUrinary Retention (UR)
Baseline: Catheterizations per day0.8 ± 1.8
6-month: Catheterizations per day0.2 ± 0.8
1-year: Catheterizations per day0.2 ± 0.9
PrimaryPerformance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or 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:
6-months, 1-year
Reported as:
Mean · score on a scale
Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline
score on a scaleFecal Incontinence (FI)
Baseline CCF-FIS Score10.7 ± 4.1
6-Month: CCF-FIS Score6.3 ± 4.5
1-Year CCF-FIS Score6.8 ± 4.9
PrimaryPerformance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort

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.

Time frame:
6-months, 1-year
Reported as:
Mean · score on a scale
Performance/Effectiveness - Change in FIQL Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline in the Implanted Cohort
score on a scaleFecal Incontinence (FI)
Baseline: Lifestyle2.7 ± 1.0
Baseline: Coping/Behavior2.1 ± 0.8
Baseline: Depression/Self Perception3.0 ± 0.9
Baseline: Embarrassment2.2 ± 0.9
6-Month: Lifestyle3.4 ± 0.8
6-Month: Coping/Behavior2.9 ± 0.9
6-Month: Depression/Self Perception3.6 ± 0.8
6-Month: Embarrassment3.0 ± 1.0
1-Year: Lifestyle3.1 ± 1.0
1-Year: Coping/Behavior2.7 ± 0.8
1-Year: Depression/Self Perception3.7 ± 0.7
1-Year: Embarrassment2.7 ± 1.0
PrimaryPerformance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort

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.

Time frame:
6-months, 1-year
Reported as:
Mean · score on a scale
Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort
score on a scaleOveractive Bladder (OAB) - Urinary Frequency (UF)
Baseline: Total Score20.7 ± 6.8
6-Month: Total Score11.7 ± 8.2
1-Year Total Score11.8 ± 7.7
PrimaryPerformance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort

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.

Time frame:
6-months, 1-year
Reported as:
Mean · score on a scale
Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort
score on a scaleUrinary Retention (UR)
Baseline: AUA-SI Score18.7 ± 8.6
6-Month: AUA-SI Score10.4 ± 8.1
1-Year: AUA-SI Score10.3 ± 8.4
PrimaryAdverse Event Reporting (Safety)

The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs).

Time frame:
1-year
Reported as:
Number · number of events
Adverse Event Reporting (Safety)
number of eventsOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Device-related SAEs0
Procedure-related SAEs2
Device- and Procedure-related SAEs0
SAEs (not device- or procedure-related)13

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)1/253 (0.4%)14/253 (5.5%)20/253 (7.9%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Transient Ischemic AttackNervous system disorders2/253
Acute EncephalopathyNervous system disorders1/253
Orthostatic HypotensionBlood and lymphatic system disorders1/253
SyncopeNervous system disorders1/253
Pain at INS SiteMusculoskeletal and connective tissue disorders1/253
Urinary Tract InfectionInfections and infestations1/253
HypernatremiaBlood and lymphatic system disorders1/253
Chest PainCardiac disorders1/253
Exacerbation of Hypokalemic Periodic ParalysisMusculoskeletal and connective tissue disorders1/253
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/253
Most frequent other events
Showing 10 of 12
Most frequent other events
EventOveractive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Uncomfortable/Undesirable StimulationNervous system disorders5/253
Implant Site InfectionInfections and infestations3/253
Pain at Lead SiteSkin and subcutaneous tissue disorders2/253
Pain at INS SiteSkin and subcutaneous tissue disorders2/253
Implant Site IndurationSkin and subcutaneous tissue disorders1/253
Lead ErosionProduct Issues1/253
Lead MigrationProduct Issues1/253
Loss of EfficacyNervous system disorders1/253
Pain at Contralateral HipMusculoskeletal and connective tissue disorders1/253
SciaticaMusculoskeletal and connective tissue disorders1/253

Baseline characteristics

Characteristics of the Treated study population. Participants in the Treated analysis population are those who were implanted with PNE or tined leads.

Age, Categorical
Age, Categorical(Participants)Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
<=18 years0
Between 18 and 65 years97
>=65 years153
Sex: Female, Male
Sex: Female, Male(Participants)Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Female218
Male32
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Hispanic or Latino10
Not Hispanic or Latino240
Unknown or Not Reported0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
Race — African American23
Race — American Indian or Alaska Native1
Race — Asian2
Race — Caucasian217
Race — Latino or Hispanic5
Race — Other1
Race — Declined to state1
Region of Enrollment
Region of Enrollment(Participants)Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
United States250
BMI
BMI(participants)Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI)
< 18.5 kg/m22
18.5-24.9 kg/m242
25.0-29.9 kg/m279
30.0-34.9 kg/m260
35.0-39.9 kg/m228
>=40.0 kg/m225
Unknown14
07

Study locations

27 sites
  • Arkansas Urology Research Center
    Little Rock, Arkansas 72210, United States
  • University of California, Irvine
    Irvine, California 92697, United States
  • Stanford Medicine
    Redwood City, California 94063, United States
  • Sansum Clinic Urology
    Santa Barbara, California 93105, United States
  • Manatee Medical Research Institute
    Bradenton, Florida 34205, United States
  • Urologic Solutions
    Fort Myers, Florida 33908, United States
  • Florida Urology Partners
    North Redington Beach, Florida 33708, United States
  • Pinellas Urology
    St. Petersburg, Florida 33710, United States
  • Florida Urology Partners
    Tampa, Florida 33606, United States
  • Northwestern
    Chicago, Illinois 60611, United States
  • LSU Health
    New Orleans, Louisiana 70112, United States
  • Ochsner Health
    New Orleans, Louisiana 70121, United States
  • Chesapeake Urology
    Hanover, Maryland 21076, United States
  • Comprehensive Urology
    Royal Oak, Michigan 48073, United States
  • Adult Pediatric Urology & Urogynecology
    Omaha, Nebraska 68114, United States
  • The Urology Center PC
    Omaha, Nebraska 68114, United States
  • New Jersey Urology
    Englewood, New Jersey 07631, United States
  • Stony Brook University
    Stony Brook, New York 11794, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267-0558, United States
  • Urologic Specialists Oklahoma
    Tulsa, Oklahoma 74146, United States
  • Institute for Female Pelvic Medicine and Reconstructive Surgery
    Allentown, Pennsylvania 18103, United States
  • Penn State University
    Hershey, Pennsylvania 17033, United States
  • The Female Pelvic Health Center
    Newtown, Pennsylvania 33606, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Southern Urogynecology
    West Columbia, South Carolina 29169, United States
  • Center for Pelvic Health
    Franklin, Tennessee 37067, United States
  • University of Alberta
    Edmonton, Alberta, Canada
08

References and documents

Study documents

  • Study protocol · Nov 12, 2020
  • Informed consent form · Nov 6, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05064384
Lead sponsor
Axonics, Inc.
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
Nov 30, 2020
Primary completion
Oct 6, 2023
Completion
Mar 31, 2024
Results posted
Jun 5, 2025
Last update
Sep 22, 2025

Study contacts

Karen Noblett, MD
study director · Axonics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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