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The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStimâ„¢ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | RENOVA iStimâ„¢ System implanted patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENOVA iStimâ„¢ System | Device | Tibial implantable neuromodulation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| ≥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. | 6 months |
| 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). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Heesakkers, MD | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39585851 | Derived | Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, Digesu A, Amundsen CL, McCrery RJ, De Wachter S, Kean ER, Martens F, Benson K, Ferrante KL, Cline KJ, Padron OF, Giusto L, Lane FL, Witte LPW, Dmochowski RR. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence. J Urol. 2025 Mar;213(3):323-332. doi: 10.1097/JU.0000000000004328. Epub 2024 Nov 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | RENOVA iStimâ„¢ System implanted patients RENOVA iStimâ„¢ System: Tibial implantable neuromodulation device |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2021 | Jul 22, 2025 |
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| San Diego |
| California |
| 92110 |
| United States |
| Norwalk Urology | Norwalk | Connecticut | 06850 | United States |
| Florida Urology Partners | Tampa | Florida | 33615 | United States |
| Comprehensive Urologic Care | Lake Barrington | Illinois | 60010 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology - Hanover | Hanover | Maryland | 21076 | United States |
| Chesapeake Urology - Owing Mills | Owings Mills | Maryland | 21117 | United States |
| Minnesota Urology | Woodbury | Minnesota | 55125 | United States |
| Adult Pediatric Urology & Urogynecology | Omaha | Nebraska | 68114 | United States |
| Duke Urogynecology | Durham | North Carolina | 27707 | United States |
| Southern Urogynocology | West Columbia | South Carolina | 29169 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57105 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| University Hospital Antwerp | Antwerp | 2650 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Rijnstate Hospital | Arnhem | Netherlands |
| Academic Hospital Maastricht | Maastricht | Netherlands |
| Radboud University Medical Center | Nijmegen | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| Isala | Zwolle | 8025 AB | Netherlands |
| Birmingham Women's and Children's NHS Foundation Trust | Birmingham | United Kingdom |
| Imperial College, St. Mary's Hospital | London | W2 1NY | United Kingdom |
|
| Implanted |
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| 6 Months Follow-up |
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| COMPLETED | 12 months follow-up |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | RENOVA iStimâ„¢ System implanted patients RENOVA iStimâ„¢ System: Tibial implantable neuromodulation device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Captured for US participants only. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Captured for US participants only. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||||
| Time since OAB diagnosis | Duration unreported in 1 participant | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | Percentage of Responders | 6 months |
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| 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). | Posted | Count of Participants | Participants | 12 months |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | RENOVA iStimâ„¢ System implanted patients RENOVA iStimâ„¢ System: Tibial implantable neuromodulation device | 0 | 151 | 13 | 151 | 34 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Herpes zoster meningitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chest pain | General disorders | MedDRA | Systematic Assessment |
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| Post - traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | BlueWind Medical | 612-203-5739 | peter.rodine@bluewindmedical.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2022 | Jul 22, 2025 | SAP_001.pdf |
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| White |
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| Other |
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| Not Collected - European Participants |
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| Not Hispanic or Latino |
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| Not Collected - European Participants |
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| United States |
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| United Kingdom |
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| 6 months to 1 year |
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| 1-5 years |
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| > 5 years |
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Subjects with reported Adverse Events (AEs) |
| |||||
| Subjects with procedure-related AEs (CEC adjudicated) |
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| Subjects with device-related AEs (CEC adjudicated) |
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| Subjects with wound-related AEs (CEC adjudicated) |
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| Subjects with a reported Serious Adverse Event (SAE) (CEC Adjudicated) |
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