Over Active BladderOABNCT02299544
BlueWind Medical System for the Treatment of Patients With OAB
A study testing BlueWind Medical system in people with Over Active Bladder, run by BlueWind Medical at 6 sites in 2 countries.
Trial summary
BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Over Active Bladder
- What is being tested?
- BlueWind Medical system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Male or female aged 18 - 80.
- Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- Patients with overactive bladder symptoms:
- Urinary frequency greater than 8 times/24 hours AND/OR Urinary urgency leaks of at least 2 leaks on 3 day voiding diary
- Patient who has failed conservative treatment after at least 6 months of treatment
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- Patients with normally functioning upper urinary tract.
- Patients with no clinical evidence of a neurological S2-S4 motor sensory deficit.
- Prior PTNS Group: Patients who have had successful PTNS treatment (successful treatment is defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review).
- De novo Patient Group: Patient who passes the BlueWind compatibility test.
Who cannot join
- Any metal implant in the area of BlueWind Medical implantation site.
- Patients who have not had stable OAB medications for at least 30 days.
- Patients who have received botulinum toxin injections within the past 6 months.
- Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months.
- Any spinal or genitourinary surgery within the last 6 months. Pelvic pain disorders
- Obvious clinically demonstrated genuine stress incontinence.
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- Any neurological disease or disorder including neuropathy or injury resulting in neuropathy.
- Current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.)
- Pelvic radiotherapy and chemotherapy.
- Severe uncontrolled diabetes.
- Patients anticipating magnetic resonance imaging (MRI) exams.
- Presence of cystocele, enterocele or rectocele of grade 3 or 4.
- Prior PTNS Group: Patients who are receiving concomitant nerve stimulation therapies for OAB treatment, except for PTNS maintenance therapy.
- De novo Patient Group: Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including PTNS.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Netherlands3 sites
Catharina Ziekenhuis
Eindhoven
Maastricht UMC
Maastricht
Radboud university medical center Department of Urology
Nijmegen
United Kingdom3 sites
Southmead Hosital
Bristol
College Hospital and National Hospital for Neurology and Neurosurgery
London
St. Mary's Hospital, Imperial College
London
About this study
Official title: Safety and Performance of the BlueWind System for the Treatment of Patients With Overactive Bladder (OAB) Amended to Allow Extended Follow up of the Patients
BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
Read the detailed description
BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
- Conditions
- Over Active Bladder
- Being tested
- BlueWind Medical system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueWind Medical systemDevice
The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.
| Study group | Role | What they receive |
|---|---|---|
| OAB | Experimental | Patients with overactive bladder (OAB) with or without urge incontinence.
Two patient populations will be enrolled in the study:
Patients with no previous treatment with percutaneous tibial nerve stimulation (PTNS) [de novo patient group] and Patients with a documented success on PTNS therapy [prior-PTNS group]. Documented success on PTNS is defined by a ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review.
All patients will be treated with BlueWind Medical System. Receives: Device: BlueWind Medical system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
Incidence of serious adverse events system and or procedure related
Measured: 6 months
Incidence of serious adverse events (amended)
Incidence of serious adverse events system and or procedure related (amended)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Over Active BladderStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlueWind Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Heesakkers, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299544
- Sponsor's protocol ID
- CP-03-001
- Acronym
- OAB
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2014
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the BlueWind System for the Treatment of Patients With Overactive Bladder (OAB) Amended to Allow Extended Follow up of the Patients
- ClinicalTrials.gov ID
- NCT02299544
- Acronym / sponsor ID
- OAB / CP-03-001
- Conditions
- Over Active Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BlueWind MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
Detailed description
BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OAB | Experimental | Device: BlueWind Medical systemPatients with overactive bladder (OAB) with or without urge incontinence. Two patient populations will be enrolled in the study: Patients with no previous treatment with percutaneous tibial nerve stimulation (PTNS) [de novo patient group] and Patients with a documented success on PTNS therapy [prior-PTNS group]. Documented success on PTNS is defined by a ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review. All patients will be treated with BlueWind Medical System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent.
- Male or female aged 18 - 80.
- Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- Patients with overactive bladder symptoms:
- Urinary frequency greater than 8 times/24 hours AND/OR Urinary urgency leaks of at least 2 leaks on 3 day voiding diary
Key exclusion criteria (14 listed)
- Any metal implant in the area of BlueWind Medical implantation site.
- Patients who have not had stable OAB medications for at least 30 days.
- Patients who have received botulinum toxin injections within the past 6 months.
- Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months.
- Any spinal or genitourinary surgery within the last 6 months. Pelvic pain disorders
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 |
|---|---|---|
| BlueWind Medical systemThe BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence. | Device | OAB |
Primary outcome
Incidence of serious adverse events
Time frame: 6 months
Incidence of serious adverse events system and or procedure related
Incidence of serious adverse events (amended)
Time frame: 36 months
Incidence of serious adverse events system and or procedure related (amended)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
Related trials for Over Active Bladder
Enrolling by invitationObservational study
Autologous Platelet Concentrate Bladder Injection for Refractory Overactive Bladder
Over Active Bladder
Recruiting
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Over Active Bladder, Urinary Incontinence (UI)
Not yet recruiting
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Over Active Bladder
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
Principal Investigator
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlueWind Medical system in people with Over Active Bladder, run by BlueWind Medical at 6 sites in 2 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 10 inclusion and 14 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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of serious adverse events (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?
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 18 Jun 2019.