BlueWind Medical System for the Treatment of Patients With OAB

NCT02299544 | Completed

• 1 other identifier: CP-03-001
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 6

Brief Summary

BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)

Conditions

Over Active Bladder

Outcome Measures

Primary Outcomes (2)

• Incidence of serious adverse events

  Incidence of serious adverse events system and or procedure related

  6 months

• Incidence of serious adverse events (amended)

  Incidence of serious adverse events system and or procedure related (amended)

  36 months

Study Arms (1)

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.

Device: BlueWind Medical system

Interventions

BlueWind Medical system DEVICE

The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.

OAB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BlueWind Medical: lead

Study Sites (6)

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maastricht UMC

Maastricht, Netherlands

Location

Radboud university medical center Department of Urology

Nijmegen, Netherlands

Location

Southmead Hosital

Bristol, United Kingdom

Location

College Hospital and National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

St. Mary's Hospital, Imperial College

London, United Kingdom

Location

Study Officials

• John Heesakkers, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 24, 2014
• Study Start: February 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 18, 2019

Record last verified: 2018-11

Locations

GB (3); NL (3)