Urinary Urge Incontinence
Conditions
Keywords
Urinary, Incontinence
Brief summary
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
Detailed description
This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.
Interventions
DEVICEInterStim Therapy
Device Programming
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes 2. Female subjects 18 years of age or older 3. Candidate for InterStim Lead Placement 4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study) 5. Willing and able to provide signed and dated informed consent 6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication
Exclusion criteria
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury 2. History of diabetes unless the diabetes is well-controlled through diet and/or medications 3. Symptomatic urinary tract infection (UTI) 4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study 6. Implanted with a neurostimulator, pacemaker, or defibrillator 7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy 8. Women who are pregnant or planning to become pregnant 9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements. 10. Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | 12 weeks | Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | 12 weeks | International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. Interference was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life. |
Countries
Belgium, Canada, France, Italy, Netherlands, United Kingdom, United States
Participant flow
Recruitment details
Out of 97 subjects enrolled in the study, 48 were randomized, 46 were implanted with a neurostimulator device, and 43 completed their 12 week follow-up visit before exiting the study. Nineteen were randomized to 50% of sensory threshold, 14 were randomized to 80% of sensory threshold, and 15 were randomized to sensory threshold.
Participants by arm
| Arm | Count |
|---|---|
| Amplitude Setting #1 = 50% Sensory Threshold InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming | 19 |
| Amplitude Setting #2 = 80% Sensory Threshold InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming | 14 |
| Amplitude Setting #3 = Sensory Threshold InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming | 15 |
| Total | 48 |
Baseline characteristics
| Characteristic | Amplitude Setting #1 = 50% Sensory Threshold | Amplitude Setting #2 = 80% Sensory Threshold | Amplitude Setting #3 = Sensory Threshold | Total |
|---|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 16 | 57.9 years STANDARD_DEVIATION 16.1 | 56.7 years STANDARD_DEVIATION 14.9 | 60 years STANDARD_DEVIATION 15.7 |
| BMI | 30.0 kg/m^2 STANDARD_DEVIATION 5.7 | 36.3 kg/m^2 STANDARD_DEVIATION 11.2 | 33.1 kg/m^2 STANDARD_DEVIATION 6.4 | 32.8 kg/m^2 STANDARD_DEVIATION 8.1 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 14 Participants | 15 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 3 / 19 | 1 / 14 | 3 / 15 |
| serious Total, serious adverse events | 3 / 19 | 1 / 14 | 3 / 15 |
Outcome results
Primary
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
Time frame: 12 weeks
Population: Complete Case Subject Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amplitude Setting #1 = 50% Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | UUI episodes per day at 12 weeks | 1.4 UUI episodes/day | Standard Deviation 2.6 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | UUI episodes per day at Baseline | 4.4 UUI episodes/day | Standard Deviation 2.9 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | Change in UUI episodes per day from baseline to 12 weeks | -3 UUI episodes/day | Standard Deviation 2.6 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | UUI episodes per day at 12 weeks | 2.4 UUI episodes/day | Standard Deviation 3 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | Change in UUI episodes per day from baseline to 12 weeks | -2.9 UUI episodes/day | Standard Deviation 2.9 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | UUI episodes per day at Baseline | 5.3 UUI episodes/day | Standard Deviation 3.1 |
| Amplitude Setting #3 = Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | UUI episodes per day at 12 weeks | 1.5 UUI episodes/day | Standard Deviation 2.3 |
| Amplitude Setting #3 = Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | UUI episodes per day at Baseline | 5.1 UUI episodes/day | Standard Deviation 4.7 |
| Amplitude Setting #3 = Sensory Threshold | Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks. | Change in UUI episodes per day from baseline to 12 weeks | -3.6 UUI episodes/day | Standard Deviation 2.8 |
Secondary
Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.
International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. Interference was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.
Time frame: 12 weeks
Population: Complete Case Subject Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amplitude Setting #1 = 50% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Coping from baseline to 12 weeks | 44.4 units on a scale | Standard Deviation 30.4 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Concern from baseline to 12 weeks | 48.2 units on a scale | Standard Deviation 28.9 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Sleep from baseline to 12 weeks | 31.4 units on a scale | Standard Deviation 26.6 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Social from baseline to 12 weeks | 20.9 units on a scale | Standard Deviation 25 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in HRQL from baseline to 12 weeks | 38.1 units on a scale | Standard Deviation 24.4 |
| Amplitude Setting #1 = 50% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Interference from baseline to 12 weeks | -5.2 units on a scale | Standard Deviation 3.3 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Interference from baseline to 12 weeks | -4.7 units on a scale | Standard Deviation 3 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Coping from baseline to 12 weeks | 41.0 units on a scale | Standard Deviation 26.3 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Social from baseline to 12 weeks | 28.6 units on a scale | Standard Deviation 17 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in HRQL from baseline to 12 weeks | 40.5 units on a scale | Standard Deviation 16.7 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Concern from baseline to 12 weeks | 50.3 units on a scale | Standard Deviation 17 |
| Amplitude Setting #2 = 80% Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Sleep from baseline to 12 weeks | 37.8 units on a scale | Standard Deviation 22.7 |
| Amplitude Setting #3 = Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Concern from baseline to 12 weeks | 49.9 units on a scale | Standard Deviation 30.2 |
| Amplitude Setting #3 = Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Sleep from baseline to 12 weeks | 32.0 units on a scale | Standard Deviation 31.6 |
| Amplitude Setting #3 = Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Interference from baseline to 12 weeks | -4.7 units on a scale | Standard Deviation 3.5 |
| Amplitude Setting #3 = Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Social from baseline to 12 weeks | 20.6 units on a scale | Standard Deviation 19.9 |
| Amplitude Setting #3 = Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in Coping from baseline to 12 weeks | 39.4 units on a scale | Standard Deviation 27.9 |
| Amplitude Setting #3 = Sensory Threshold | Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks. | Change in HRQL from baseline to 12 weeks | 37.1 units on a scale | Standard Deviation 23.4 |