Trial Outcomes & Findings for InterStim® Amplitude Study (NCT NCT03335761)
NCT ID: NCT03335761
Last Updated: 2021-01-08
Results Overview
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-01-08
Participant Flow
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.
Participant milestones
| Measure |
Amplitude Setting #1 = 50% Sensory Threshold
InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #2 = 80% Sensory Threshold
InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #3 = Sensory Threshold
InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
14
|
15
|
|
Overall Study
Implanted With a Neurostimulator Device
|
18
|
14
|
14
|
|
Overall Study
COMPLETED
|
17
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Amplitude Setting #1 = 50% Sensory Threshold
n=19 Participants
InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #2 = 80% Sensory Threshold
n=14 Participants
InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #3 = Sensory Threshold
n=15 Participants
InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 16 • n=19 Participants
|
57.9 years
STANDARD_DEVIATION 16.1 • n=14 Participants
|
56.7 years
STANDARD_DEVIATION 14.9 • n=15 Participants
|
60 years
STANDARD_DEVIATION 15.7 • n=48 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=19 Participants
|
14 Participants
n=14 Participants
|
15 Participants
n=15 Participants
|
48 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
30.0 kg/m^2
STANDARD_DEVIATION 5.7 • n=19 Participants
|
36.3 kg/m^2
STANDARD_DEVIATION 11.2 • n=14 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 6.4 • n=15 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 8.1 • n=48 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Complete Case Subject Set
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
Outcome measures
| Measure |
Amplitude Setting #1 = 50% Sensory Threshold
n=17 Participants
InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #2 = 80% Sensory Threshold
n=13 Participants
InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #3 = Sensory Threshold
n=13 Participants
InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming
|
|---|---|---|---|
|
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
|
5.3 UUI episodes/day
Standard Deviation 3.1
|
5.1 UUI episodes/day
Standard Deviation 4.7
|
|
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
|
2.4 UUI episodes/day
Standard Deviation 3.0
|
1.5 UUI episodes/day
Standard Deviation 2.3
|
|
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
|
-2.9 UUI episodes/day
Standard Deviation 2.9
|
-3.6 UUI episodes/day
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Complete Case Subject Set
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.
Outcome measures
| Measure |
Amplitude Setting #1 = 50% Sensory Threshold
n=17 Participants
InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #2 = 80% Sensory Threshold
n=13 Participants
InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #3 = Sensory Threshold
n=13 Participants
InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming
|
|---|---|---|---|
|
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
|
41.0 units on a scale
Standard Deviation 26.3
|
39.4 units on a scale
Standard Deviation 27.9
|
|
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
|
50.3 units on a scale
Standard Deviation 17
|
49.9 units on a scale
Standard Deviation 30.2
|
|
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
|
37.8 units on a scale
Standard Deviation 22.7
|
32.0 units on a scale
Standard Deviation 31.6
|
|
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 25.0
|
28.6 units on a scale
Standard Deviation 17
|
20.6 units on a scale
Standard Deviation 19.9
|
|
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
|
40.5 units on a scale
Standard Deviation 16.7
|
37.1 units on a scale
Standard Deviation 23.4
|
|
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
|
-4.7 units on a scale
Standard Deviation 3.0
|
-4.7 units on a scale
Standard Deviation 3.5
|
Adverse Events
Amplitude Setting #1 = 50% Sensory Threshold
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Amplitude Setting #2 = 80% Sensory Threshold
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Amplitude Setting #3 = Sensory Threshold
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amplitude Setting #1 = 50% Sensory Threshold
n=19 participants at risk
InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #2 = 80% Sensory Threshold
n=14 participants at risk
InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #3 = Sensory Threshold
n=15 participants at risk
InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
6.7%
1/15 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Infections and infestations
Sepsis
|
5.3%
1/19 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/15 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Psychiatric disorders
Suicide attempt
|
5.3%
1/19 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/15 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
7.1%
1/14 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/15 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
6.7%
1/15 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
6.7%
1/15 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Gastrointestinal disorders
Umbilical hernia
|
5.3%
1/19 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/15 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
6.7%
1/15 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
Other adverse events
| Measure |
Amplitude Setting #1 = 50% Sensory Threshold
n=19 participants at risk
InterStim Therapy will be set to amplitude parameter #1 (50% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #2 = 80% Sensory Threshold
n=14 participants at risk
InterStim Therapy will be set to amplitude parameter #2 (80% Sensory Threshold)
InterStim Therapy: Device Programming
|
Amplitude Setting #3 = Sensory Threshold
n=15 participants at risk
InterStim Therapy will be set to amplitude parameter #3 (Sensory Threshold)
InterStim Therapy: Device Programming
|
|---|---|---|---|
|
General disorders
Medical device site pain
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
7.1%
1/14 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/15 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/15 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
13.3%
2/15 • Number of events 2 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
6.7%
1/15 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
|
General disorders
Pain
|
0.00%
0/19 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
0.00%
0/14 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
6.7%
1/15 • Number of events 1 • From Post-Neurostimulator device implant to 12 weeks follow-up visit
Serious, device related, procedure related, and/or therapy related adverse events are considered reportable for this study
|
Additional Information
Mylène Champs (Sr Clinical Research Specialist)
Medtronic
Phone: +17635261627
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place