18 and older, female only, with Urinary Urge Incontinence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.Primary· 12 weeks
Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.
UUI episodes per day at Baseline
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
4.4
± 2.9
Amplitude Setting #2 = 80% Sensory Threshold
5.3
± 3.1
Amplitude Setting #3 = Sensory Threshold
5.1
± 4.7
UUI episodes per day at 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
1.4
± 2.6
Amplitude Setting #2 = 80% Sensory Threshold
2.4
± 3.0
Amplitude Setting #3 = Sensory Threshold
1.5
± 2.3
Change in UUI episodes per day from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
-3
± 2.6
Amplitude Setting #2 = 80% Sensory Threshold
-2.9
± 2.9
Amplitude Setting #3 = Sensory Threshold
-3.6
± 2.8
Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.Secondary· 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 fr
Change in Coping from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
44.4
± 30.4
Amplitude Setting #2 = 80% Sensory Threshold
41.0
± 26.3
Amplitude Setting #3 = Sensory Threshold
39.4
± 27.9
Change in Concern from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
48.2
± 28.9
Amplitude Setting #2 = 80% Sensory Threshold
50.3
± 17
Amplitude Setting #3 = Sensory Threshold
49.9
± 30.2
Change in Sleep from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
31.4
± 26.6
Amplitude Setting #2 = 80% Sensory Threshold
37.8
± 22.7
Amplitude Setting #3 = Sensory Threshold
32.0
± 31.6
Change in Social from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
20.9
± 25.0
Amplitude Setting #2 = 80% Sensory Threshold
28.6
± 17
Amplitude Setting #3 = Sensory Threshold
20.6
± 19.9
Change in HRQL from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
38.1
± 24.4
Amplitude Setting #2 = 80% Sensory Threshold
40.5
± 16.7
Amplitude Setting #3 = Sensory Threshold
37.1
± 23.4
Change in Interference from baseline to 12 weeks
Group
Value
95% CI
Amplitude Setting #1 = 50% Sensory Threshold
-5.2
± 3.3
Amplitude Setting #2 = 80% Sensory Threshold
-4.7
± 3.0
Amplitude Setting #3 = Sensory Threshold
-4.7
± 3.5
Adverse events — posted to ClinicalTrials.gov
Time frame: From Post-Neurostimulator device implant to 12 weeks follow-up visit.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedtronicNeuro
Last refreshed: 8 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03335761.