Fecal Incontinence, Urgency-Frequency, Urinary Retention, Urinary Urge Incontinence
Conditions
Keywords
Overactive Bladder, bladder control, bowel control
Brief summary
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
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.
Interventions
None listed
Sponsors
Axonics, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapy Responder Rate | 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 Baseline | 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 Baseline | 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. |
| Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 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 Baseline | 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. |
| Performance/Effectiveness - Improvement of Patient FI Symptoms in the Implanted Cohort From Baseline | 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. |
| Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 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. |
| Performance/Effectiveness - Improvement in Quality of Life Scoring for OAB Participants in the Implanted Cohort | 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). |
| Performance/Effectiveness - Improvement of Patient UR Symptoms in the Implanted Cohort From Baseline | 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. |
| Performance/Effectiveness - Change in CCF-FIS Score for Participants Diagnosed With FI or With a CCF-FIS Score ≥6 at Baseline | 6-months, 1-year | 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. |
| 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-months, 1-year | 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. |
| Performance/Effectiveness - Changes From Baseline in O'Leary Sant Score for Urinary Frequency Participants in the Implanted Cohort | 6-months, 1-year | 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. |
| Performance/Effectiveness - Change in AUA-SI Score for Urinary Retention Participants in the Implanted Cohort | 6-months, 1-year | 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. |
| Adverse Event Reporting (Safety) | 1-year | The number and participant rates of device-related AEs and Serious Adverse Events (SAEs), including Serious Adverse Device Effects (SADEs). |
Countries
Canada, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 250 |
| Total | 250 |
Baseline characteristics
| Characteristic | Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 153 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants |
| BMI 18.5-24.9 kg/m2 | 42 participants |
| BMI < 18.5 kg/m2 | 2 participants |
| BMI 25.0-29.9 kg/m2 | 79 participants |
| BMI 30.0-34.9 kg/m2 | 60 participants |
| BMI 35.0-39.9 kg/m2 | 28 participants |
| BMI >=40.0 kg/m2 | 25 participants |
| BMI Unknown | 14 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 240 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race African American | 23 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Caucasian | 217 Participants |
| Race/Ethnicity, Customized Race Declined to state | 1 Participants |
| Race/Ethnicity, Customized Race Latino or Hispanic | 5 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Region of Enrollment United States | 250 Participants |
| Sex: Female, Male Female | 218 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 253 |
| other Total, other adverse events | 20 / 253 |
| serious Total, serious adverse events | 14 / 253 |
Outcome results
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).
Time frame: 1-year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Adverse Event Reporting (Safety) | Device-related SAEs | 0 number of events |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Adverse Event Reporting (Safety) | Procedure-related SAEs | 2 number of events |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Adverse Event Reporting (Safety) | Device- and Procedure-related SAEs | 0 number of events |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Adverse Event Reporting (Safety) | SAEs (not device- or procedure-related) | 13 number of events |
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.
Time frame: 6-months, 1-year
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
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.
Time frame: 6-months, 1-year
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
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.
Time frame: 6-months, 1-year
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 0 | 9 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 1 | 1 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 2 | 10 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 3 | 17 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 4 | 17 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 0 | 15 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 1 | 7 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 2 | 7 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 3 | 10 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 4 | 5 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 0 | 13 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 1 | 5 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 2 | 8 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 3 | 3 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient FI Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 4 | 6 Participants |
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.
Time frame: 6-months, 1-year
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 0 | 7 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 1 | 6 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 2 | 21 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 3 | 90 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 4 | 58 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 0 | 21 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 1 | 27 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 2 | 48 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 3 | 36 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 4 | 20 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 0 | 21 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 1 | 28 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 2 | 47 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 3 | 23 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 4 | 13 Participants |
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.
Time frame: 6-months, 1-year
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 0 | 2 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 1 | 5 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 0 | 15 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 1 | 23 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 2 | 47 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 3 | 27 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 6-month: Average degree of urgency = 4 | 13 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 0 | 14 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 1 | 25 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 2 | 38 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 3 | 26 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 2 | 24 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 3 | 76 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | Baseline: Average degree of urgency = 4 | 44 Participants |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Performance/Effectiveness - Improvement of Patient Urinary Urgency Symptoms in the Implanted Cohort From Baseline | 1-year: Average degree of urgency = 4 | 13 Participants |
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.
Time frame: 6-months, 1-year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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
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
Population: Difference in number of participants across timepoints account for study exits that occurred during follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | 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 |
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.
Time frame: External Trial System Evaluation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overactive Bladder (OAB), Urinary Retention (UR), and/or Fecal Incontinence (FI) | Therapy Responder Rate | 206 Participants |