Back to resultsBlueWind Medical System for the Treatment of Patients With OAB (OAB)
Primary Purpose
Over Active Bladder
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BlueWind Medical system
Sponsored by
About this trial
This is an interventional treatment trial for Over Active Bladder
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Catharina Ziekenhuis
- Maastricht UMC
- Radboud university medical center Department of Urology
- Southmead Hosital
- College Hospital and National Hospital for Neurology and Neurosurgery
- St. Mary's Hospital, Imperial College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OAB
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of serious adverse events
Incidence of serious adverse events system and or procedure related
Incidence of serious adverse events (amended)
Incidence of serious adverse events system and or procedure related (amended)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02299544
Brief Title
BlueWind Medical System for the Treatment of Patients With OAB
Acronym
OAB
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BlueWind Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Over Active Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OAB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BlueWind Medical system
Intervention Description
The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.
Primary Outcome Measure Information:
Title
Incidence of serious adverse events
Description
Incidence of serious adverse events system and or procedure related
Time Frame
6 months
Title
Incidence of serious adverse events (amended)
Description
Incidence of serious adverse events system and or procedure related (amended)
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heesakkers, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Maastricht UMC
City
Maastricht
Country
Netherlands
Facility Name
Radboud university medical center Department of Urology
City
Nijmegen
Country
Netherlands
Facility Name
Southmead Hosital
City
Bristol
Country
United Kingdom
Facility Name
College Hospital and National Hospital for Neurology and Neurosurgery
City
London
Country
United Kingdom
Facility Name
St. Mary's Hospital, Imperial College
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
BlueWind Medical System for the Treatment of Patients With OAB
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