NCT03596671: OASIS

BlueWind RENOVA iStim™ System for the Treatment of OAB

Completed NA Results posted Last updated 16 September 2025

What this trial tests

NA trial testing RENOVA iStim™ System in Treatment of Patients Suffering From Overactive Bladder (OAB) in 282 participants. Completed in 24 January 2025.

Timeline

12 June 2019

Primary endpoint
28 October 2022

24 January 2025

Quick facts

Lead sponsor	BlueWind Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	282
Start date	12 June 2019
Primary completion	28 October 2022
Estimated completion	24 January 2025
Sites	23 locations across Belgium, United Kingdom, Netherlands, United States

Drugs / interventions tested

• RENOVA iStim™ System

Conditions studied

• Treatment of Patients Suffering From Overactive Bladder (OAB) — all drugs for Treatment of Patients Suffering From Overactive Bladder (OAB) →

Sponsor

BlueWind Medical

Who can join

Adults 18 to 80, female only, with Treatment of Patients Suffering From Overactive Bladder (OAB). 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.

≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes Primary · 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.

Group	Value	95% CI
Treatment Arm	76.4	68.7 – 82.6

Safety - Number of Participants With Adverse Events Primary · 12 months

The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).

Subjects with reported Adverse Events (AEs)

Group	Value	95% CI
Treatment Arm	117

Subjects with procedure-related AEs (CEC adjudicated)

Group	Value	95% CI
Treatment Arm	16

Subjects with device-related AEs (CEC adjudicated)

Group	Value	95% CI
Treatment Arm	6

Subjects with wound-related AEs (CEC adjudicated)

Group	Value	95% CI
Treatment Arm	10

Subjects with a reported Serious Adverse Event (SAE) (CEC Adjudicated)

Group	Value	95% CI
Treatment Arm	13

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 13/151 (9%)

Deaths: 0/151

Serious adverse events (17 terms)

Reaction	System	Treatment Arm
COVID-19	Infections and infestations	—
Cellulitis	Infections and infestations	—
Herpes zoster meningitis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Postoperative wound infection	Infections and infestations	—
Sinusitis	Infections and infestations	—
Atrioventricular block	Cardiac disorders	—
Myocardial infarction	Cardiac disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	—
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Abdominal pain	Gastrointestinal disorders	—
Chest pain	General disorders	—
Post - traumatic neck syndrome	Injury, poisoning and procedural complications	—
Nephrolithiasis	Renal and urinary disorders	—
Asthma	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment Arm
Urinary Tract Infection	Infections and infestations	—

Most-reported serious reactions: COVID-19, Cellulitis, Herpes zoster meningitis, Pneumonia, Postoperative wound infection, Sinusitis, Atrioventricular block, Myocardial infarction.

Data from ClinicalTrials.gov NCT03596671 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.
   Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, Digesu A, et al · · 2024 · cited 6× · PMID 38634481 · DOI 10.1002/nau.25477
2. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence.
   Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, Digesu A, et al · · 2025 · cited 4× · PMID 39585851 · DOI 10.1097/ju.0000000000004328
3. Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device.
   Lee UJ, Xavier K, Benson K, Burgess K, et al · · 2023 · cited 3× · PMID 37691849 · DOI 10.1016/j.conctc.2023.101198
4. Emerging Implantable Tibial Nerve Stimulation Devices for Overactive Bladder.
   Nyan TH, Park E. · · 2025 · PMID 41077787 · DOI 10.5213/inj.2550162.081