Treatment of Patients Suffering From Overactive Bladder (OAB)OASISNCT03596671

BlueWind RENOVA iStim™ System for the Treatment of OAB

A study testing RENOVA iStim™ System in people with Treatment of Patients Suffering From Overactive Bladder (OAB), run by BlueWind Medical at 23 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Treatment of Patients Suffering From Overactive Bladder (OAB)
What is being tested?: RENOVA iStim™ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 282 participants
Where: 23 sitesin 4 countries
Study dates: 12 Jun 2019to 24 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

23 sites in 4 countries.

Country

City, postcode or hospital

23 sites in 4 countries

United States14 sites

Duke Urogynecology
Durham, North Carolina, 27707
Chesapeake Urology - Hanover
Hanover, Maryland, 21076
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010
Norwalk Urology
Norwalk, Connecticut, 06850
Adult Pediatric Urology & Urogynecology
Omaha, Nebraska, 68114
University of California Irvine
Orange, California, 92868
Chesapeake Urology - Owing Mills
Owings Mills, Maryland, 21117
Kaiser Permanente
San Diego, California, 92110
University of Washington
Seattle, Washington, 98195
Regional Urology, LLC
Shreveport, Louisiana, 71106
Sanford Health
Sioux Falls, South Dakota, 57105
Florida Urology Partners
Tampa, Florida, 33615
Southern Urogynocology
West Columbia, South Carolina, 29169
Minnesota Urology
Woodbury, Minnesota, 55125

Other trials in United States

Netherlands5 sites

Rijnstate Hospital
Arnhem
Academic Hospital Maastricht
Maastricht
Radboud University Medical Center
Nijmegen
UMC Utrecht
Utrecht
Isala
Zwolle, 8025 AB

Other trials in Netherlands

Belgium2 sites

University Hospital Antwerp
Antwerp, 2650
UZ Leuven
Leuven, 3000

Other trials in Belgium

United Kingdom2 sites

Birmingham Women's and Children's NHS Foundation Trust
Birmingham
Imperial College, St. Mary's Hospital
London, W2 1NY

Other trials in United Kingdom

About this study

Official title: A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)

Conditions: Treatment of Patients Suffering From Overactive Bladder (OAB)
Being tested: RENOVA iStim™ System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RENOVA iStim™ SystemDevice
Tibial implantable neuromodulation device

Study groups in NCT03596671
Study group	Role	What they receive
Treatment arm	Experimental	RENOVA iStim™ System implanted patients Receives: Device: RENOVA iStim™ System

What is being measured

The primary outcome is the main question the study is designed to answer.

≥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.
Measured: 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).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201924 Jan 2025

First posted24 Jul 2018
Study start12 Jun 2019
Primary completion28 Oct 2022
Study completion24 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Treatment of Patients Suffering From Overactive Bladder (OAB)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03596671
Sponsor's protocol ID: G02-CLP-0002
Acronym: OASIS
Status last verified: Aug 2025
First submitted: 1 Jul 2018
Last updated: 16 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 39585851

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)
ClinicalTrials.gov ID: NCT03596671
Acronym / sponsor ID: OASIS / G02-CLP-0002
Conditions: Treatment of Patients Suffering From Overactive Bladder (OAB)
Study type: Interventional
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: BlueWind MedicalIndustry (pharma, biotech, devices)
Study start: 12 Jun 2019 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 24 Jan 2025 (actual)
First posted: 24 Jul 2018 (actual)
Results: Posted 16 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment arm	Experimental	Device: RENOVA iStim™ SystemRENOVA iStim™ System implanted patients

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RENOVA iStim™ SystemTibial implantable neuromodulation device	Device	Treatment arm

Primary outcome

≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes
Time frame: 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
Time frame: 12 months
The primary safety endpoint was to assess adverse events from implantation to 12-months post-activation (Treatment Emergent Adverse Events).

Results and safety

Results posted to the registry on 16 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm	282	140

Primary outcome: ≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes

Time frame: 6 months. Number (95% Confidence Interval). Unit: Percentage of Responders

Measure	Treatment Arm n = 151
Value	76.4 (68.7 to 82.6)

Primary outcome: Safety - Number of Participants With Adverse Events

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Treatment Arm n = 151
Subjects with reported Adverse Events (AEs)	117
Subjects with procedure-related AEs (CEC adjudicated)	16
Subjects with device-related AEs (CEC adjudicated)	6
Subjects with wound-related AEs (CEC adjudicated)	10
Subjects with a reported Serious Adverse Event (SAE) (CEC Adjudicated)	13

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	13 of 151 (8.6%)	34 of 151 (22.5%)	0 of 151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39585851Heesakkers 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Heesakkers, MD principal investigator

Maastricht University Medical Centre

23 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RENOVA iStim™ System in people with Treatment of Patients Suffering From Overactive Bladder (OAB), run by BlueWind Medical at 23 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Netherlands, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

≥50% Decrease in Mean Urinary Urgency Incontinence (UUI) Episodes (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03596671, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.