Treatment of Patients Suffering From Overactive Bladder (OAB)
Conditions
Brief summary
The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.
Interventions
DEVICERENOVA iStim™ System
Tibial implantable neuromodulation device
Sponsors
BlueWind Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female aged 18 or greater (21 in the US) * More than or equal to 6 months history of UUI diagnosis * Patient who is mentally competent with the ability to understand and comply with the requirements of the study
Exclusion criteria
* Any significant medical condition that is likely to interfere with study procedures * Patients who are breastfeeding * Predominant stress incontinence * Have a life expectancy of less than 1 year * Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes | 6 months | 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. |
| Safety - Number of Participants With Adverse Events | 12 months | The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events). |
Countries
Belgium, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm RENOVA iStim™ System implanted patients
RENOVA iStim™ System: Tibial implantable neuromodulation device | 151 |
| Total | 151 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 12.5 |
| Body Mass Index (BMI) | 30.2 kg/m2 STANDARD_DEVIATION 6.9 |
| Height | 165.4 cm STANDARD_DEVIATION 6.6 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Not Collected - European Participants | 64 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 81 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race Not Collected - European Participants | 64 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 83 Participants |
| Region of Enrollment Belgium | 11 participants |
| Region of Enrollment Netherlands | 25 participants |
| Region of Enrollment United Kingdom | 28 participants |
| Region of Enrollment United States | 87 participants |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 0 Participants |
| Time since OAB diagnosis 1-5 years | 44 Participants |
| Time since OAB diagnosis > 5 years | 97 Participants |
| Time since OAB diagnosis < 6 months | 2 Participants |
| Time since OAB diagnosis 6 months to 1 year | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 151 |
| other Total, other adverse events | 34 / 151 |
| serious Total, serious adverse events | 13 / 151 |
Outcome results
Primary
≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes | 76.4 Percentage of Responders |
Primary
Safety - Number of Participants With Adverse Events
The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Arm | Safety - Number of Participants With Adverse Events | Subjects with reported Adverse Events (AEs) | 117 Participants |
| Treatment Arm | Safety - Number of Participants With Adverse Events | Subjects with procedure-related AEs (CEC adjudicated) | 16 Participants |
| Treatment Arm | Safety - Number of Participants With Adverse Events | Subjects with device-related AEs (CEC adjudicated) | 6 Participants |
| Treatment Arm | Safety - Number of Participants With Adverse Events | Subjects with wound-related AEs (CEC adjudicated) | 10 Participants |
| Treatment Arm | Safety - Number of Participants With Adverse Events | Subjects with a reported Serious Adverse Event (SAE) (CEC Adjudicated) | 13 Participants |