Clinical trial NCT02299544: BlueWind Medical System for the Treatment of Patients With 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
Overall status: COMPLETED
Phase: NA
Conditions: Over Active Bladder
Lead sponsor: BlueWind Medical
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Incidence of serious adverse events
timeFrame: 6 months
measure: Incidence of serious adverse events (amended)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nijmegen
country: Netherlands
facility: Radboud university medical center Department of Urology
city: Bristol
country: United Kingdom
facility: Southmead Hosital
city: London
country: United Kingdom
facility: College Hospital and National Hospital for Neurology and Neurosurgery
city: London
country: United Kingdom
facility: St. Mary's Hospital, Imperial College
Study officials:
affiliation: Principal Investigator
name: John Heesakkers, MD
role: PRINCIPAL_INVESTIGATOR
References: