| Primary | 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. | | Posted | | Count of Participants | | Participants | | External Trial System Evaluation | | | | ID | Title | Description |
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| OG000 | 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 were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS). |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | leaks per day | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Urge Incontinence (UUI) | Patients diagnosed with overactive bladder (OAB) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | leaks after bed | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Urge Incontinence (UUI) | Patients diagnosed with overactive bladder (OAB) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | urinations per day | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Frequency (UF) | Patients diagnosed with overactive bladder (OAB) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | urinations at night | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Frequency (UF) | Patients diagnosed with overactive bladder (OAB) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | 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. | Posted | | Count of Participants | | Participants | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Urge Incontinence (UUI) | Patients diagnosed with overactive bladder (OAB) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | 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. | Posted | | Count of Participants | | Participants | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Frequency (UF) | Patients diagnosed with overactive bladder (OAB) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | episodes per week | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Fecal Incontinence (FI) | Patients diagnosed with Fecal Incontinence (FI) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | days per week | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Fecal Incontinence (FI) | Patients diagnosed with Fecal Incontinence (FI) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer leaks with less urgency. |
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| Primary | 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. | 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. | Posted | | Count of Participants | | Participants | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Fecal Incontinence (FI) | Patients diagnosed with Fecal Incontinence (FI) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer FI episodes with less urgency. |
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| Primary | 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). | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) | Patients diagnosed with overactive bladder (OAB)who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) that had a higher score than baseline and had a score change of 10 points or greater. |
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| Primary | 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. | 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. | Posted | | Mean | Standard Deviation | catheterizations per day | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Urinary Retention (UR) | Patients diagnosed with UR who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced fewer catheterizations. |
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| Primary | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Fecal Incontinence (FI) | Patients diagnosed with Fecal Incontinence (FI) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS) |
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| Primary | 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. | 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). | Posted | | Mean | Standard Deviation | score on a scale | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Fecal Incontinence (FI) | Patients diagnosed with fecal incontinence (FI) who underwent an Axonics External Trial System (ETS) trial and received an Axonics Implantable Neurostimulator (INS) who experienced an increase in scores for all four domains: lifestyle, coping behavior, depression or self-perception, and level of embarrassment. |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Overactive Bladder (OAB) - Urinary Frequency (UF) | Patients diagnosed with overactive bladder (OAB), urinary frequency (UF) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS) |
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| Primary | 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. | Difference in number of participants across timepoints account for study exits that occurred during follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | 6-months, 1-year | | | | ID | Title | Description |
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| OG000 | Urinary Retention (UR) | Patients diagnosed with urinary retention (UR) who were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS) |
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| Primary | Adverse Event Reporting (Safety) | The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs). | | Posted | | Number | | number of events | | 1-year | | | | ID | Title | Description |
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| OG000 | 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 were scheduled to undergo an Axonics External Trial System (ETS) trial or receive an Axonics Implantable Neurostimulator (INS). |
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