Trial Outcomes & Findings for BlueWind RENOVA iStim™ System for the Treatment of OAB (NCT NCT03596671)
NCT ID: NCT03596671
Last Updated: 2025-09-16
Results Overview
Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
282 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-16
Participant Flow
Participant milestones
| Measure |
Treatment Arm
RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device
|
|---|---|
|
Overall Study
STARTED
|
282
|
|
Overall Study
Implanted
|
151
|
|
Overall Study
6 Months Follow-up
|
144
|
|
Overall Study
COMPLETED
|
140
|
|
Overall Study
NOT COMPLETED
|
142
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Captured for US participants only.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=151 Participants
RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device
|
|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 12.5 • n=151 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=151 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=151 Participants • Captured for US participants only.
|
|
Race/Ethnicity, Customized
Race · White
|
83 Participants
n=151 Participants • Captured for US participants only.
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=151 Participants • Captured for US participants only.
|
|
Race/Ethnicity, Customized
Race · Not Collected - European Participants
|
64 Participants
n=151 Participants • Captured for US participants only.
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
6 Participants
n=151 Participants • Captured for US participants only.
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
81 Participants
n=151 Participants • Captured for US participants only.
|
|
Race/Ethnicity, Customized
Ethnicity · Not Collected - European Participants
|
64 Participants
n=151 Participants • Captured for US participants only.
|
|
Region of Enrollment
Netherlands
|
25 participants
n=151 Participants
|
|
Region of Enrollment
Belgium
|
11 participants
n=151 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=151 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=151 Participants
|
|
Height
|
165.4 cm
STANDARD_DEVIATION 6.6 • n=151 Participants
|
|
Body Mass Index (BMI)
|
30.2 kg/m2
STANDARD_DEVIATION 6.9 • n=151 Participants
|
|
Time since OAB diagnosis
< 6 months
|
2 Participants
n=150 Participants • Duration unreported in 1 participant
|
|
Time since OAB diagnosis
6 months to 1 year
|
7 Participants
n=150 Participants • Duration unreported in 1 participant
|
|
Time since OAB diagnosis
1-5 years
|
44 Participants
n=150 Participants • Duration unreported in 1 participant
|
|
Time since OAB diagnosis
> 5 years
|
97 Participants
n=150 Participants • Duration unreported in 1 participant
|
PRIMARY outcome
Timeframe: 6 monthsProportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary.
Outcome measures
| Measure |
Treatment Arm
n=151 Participants
RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device
|
|---|---|
|
≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
|
76.4 Percentage of Responders
Interval 68.7 to 82.6
|
PRIMARY outcome
Timeframe: 12 monthsThe primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).
Outcome measures
| Measure |
Treatment Arm
n=151 Participants
RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device
|
|---|---|
|
Safety - Number of Participants With Adverse Events
Subjects with reported Adverse Events (AEs)
|
117 Participants
|
|
Safety - Number of Participants With Adverse Events
Subjects with procedure-related AEs (CEC adjudicated)
|
16 Participants
|
|
Safety - Number of Participants With Adverse Events
Subjects with device-related AEs (CEC adjudicated)
|
6 Participants
|
|
Safety - Number of Participants With Adverse Events
Subjects with wound-related AEs (CEC adjudicated)
|
10 Participants
|
|
Safety - Number of Participants With Adverse Events
Subjects with a reported Serious Adverse Event (SAE) (CEC Adjudicated)
|
13 Participants
|
Adverse Events
Treatment Arm
Serious events: 13 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=151 participants at risk
RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device
|
|---|---|
|
Infections and infestations
COVID-19
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Infections and infestations
Cellulitis
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Infections and infestations
Herpes zoster meningitis
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Infections and infestations
Pneumonia
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Infections and infestations
Postoperative wound infection
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Infections and infestations
Sinusitis
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Cardiac disorders
Atrioventricular block
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
General disorders
Chest pain
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Injury, poisoning and procedural complications
Post - traumatic neck syndrome
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.66%
1/151 • Number of events 1 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
Other adverse events
| Measure |
Treatment Arm
n=151 participants at risk
RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device
|
|---|---|
|
Infections and infestations
Urinary Tract Infection
|
22.5%
34/151 • Number of events 34 • 12 months
Safety events have been reported for all subjects in which an implant of the BlueWind device was attempted. All subjects in whom an implant was attempted were successfully implanted.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place