Fecal Incontinence, Non-obstructive Urinary Retention, Overactive Bladder
Conditions
Brief summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
Interventions
DEVICEInterStim Micro
Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
Sponsors
MedtronicNeuro
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Overactive Bladder Cohort Inclusion Criteria: 1. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours 2. Subjects 18 years of age or older 3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling 4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol 5. Willing and able to provide signed and dated informed consent
Exclusion criteria
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) 4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months 5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy 6. Women who are pregnant or planning to become pregnant 7. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 8. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results. Fecal Incontinence Cohort Inclusion Criteria: 1. Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe soiling) 2. Subjects 18 years of age or older 3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling 4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol 5. Willing and able to provide signed and dated informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for HRQL Total Score | 3 months | The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is. |
| Change From Baseline in CCIS Score | 3 months | The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is. |
| Change From Baseline in the Number of CISC/Day | 3 months | Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline. |
Countries
Canada, France, Netherlands, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overactive Bladder Cohort Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms. | 68 |
| Fecal Incontinence Cohort Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms. | 53 |
| Non-Obstructive Urinary Retention Cohort Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms. | 27 |
| Total | 148 |
Baseline characteristics
| Characteristic | Overactive Bladder Cohort | Total | Fecal Incontinence Cohort | Non-Obstructive Urinary Retention Cohort |
|---|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 13.2 | 57 years STANDARD_DEVIATION 15.1 | 58 years STANDARD_DEVIATION 11 | 43 years STANDARD_DEVIATION 17.9 |
| Clean intermittent self-catheterizations (CISC) per day | — | 5 Clean intermittent self-catheterizations STANDARD_DEVIATION 2.3 | — | 5 Clean intermittent self-catheterizations STANDARD_DEVIATION 2.3 |
| Cleveland Clinic Incontinence Score (CCIS) | — | 14 Score STANDARD_DEVIATION 2.9 | 14 Score STANDARD_DEVIATION 2.9 | — |
| Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) | 44 Total Score STANDARD_DEVIATION 21.7 | 44 Total Score STANDARD_DEVIATION 21.7 | — | — |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 5 Participants | 9 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized SPANISH/HISPANIC/LATINA | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 54 Participants | 100 Participants | 37 Participants | 9 Participants |
| Region of Enrollment Canada | 4 participants | 19 participants | 12 participants | 3 participants |
| Region of Enrollment France | 8 participants | 21 participants | 7 participants | 6 participants |
| Region of Enrollment Netherlands | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Switzerland | 0 participants | 2 participants | 2 participants | 0 participants |
| Region of Enrollment United Kingdom | 0 participants | 10 participants | 0 participants | 10 participants |
| Region of Enrollment United States | 56 participants | 95 participants | 32 participants | 7 participants |
| Sex: Female, Male Female | 61 Participants | 135 Participants | 48 Participants | 26 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 68 | 0 / 53 | 0 / 27 |
| other Total, other adverse events | 5 / 68 | 8 / 53 | 14 / 27 |
| serious Total, serious adverse events | 3 / 68 | 8 / 53 | 4 / 27 |
Outcome results
Primary
Change From Baseline for HRQL Total Score
The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. We are reporting the change from baseline for HRQL total score. If the change is positive, it means a better quality of life. The higher the positive change is, the better the quality of life is.
Time frame: 3 months
Population: This score is applicable only for the OAB cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overactive Bladder Cohort | Change From Baseline for HRQL Total Score | 33 Total score on a scale | Standard Deviation 24.2 |
Primary
Change From Baseline in CCIS Score
The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was developed to assess the frequency and severity of fecal incontinence. CCIS-Wexner score ranges between 0 and 20. Higher scores indicate worse incontinence. We are reporting the change from baseline for CCIS Score. If the change is negative, the quality of life improved from baseline. The more negative the score is, the better the quality of life is.
Time frame: 3 months
Population: This score is only applicable for FI subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fecal Incontinence Cohort | Change From Baseline in CCIS Score | -4.06 score on a scale | Standard Deviation 3.696 |
Primary
Change From Baseline in the Number of CISC/Day
Subjects reported the clean intermittent self-catheterizations on voiding diaries for 7 consecutive days. We are reporting the change from baseline. If the change is negative, the quality of life is improved from baseline.
Time frame: 3 months
Population: This measure applies only to subjects in the NOUR Cohort.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Obstructive Urinary Retention Cohort | Change From Baseline in the Number of CISC/Day | -3.52 Number of CISC/Day | Standard Deviation 2.901 |