BlueWind Medical System for the Treatment of Patients With OAB (OAB)

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)

Study Overview

• Status: Completed
• Conditions: Over Active Bladder
• Intervention / Treatment: Device: BlueWind Medical system

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Maastricht, Netherlands
    • Maastricht UMC
  • Nijmegen, Netherlands
    • Radboud university medical center Department of Urology
• United Kingdom
  • Bristol, United Kingdom
    • Southmead Hosital
  • London, United Kingdom
    • College Hospital and National Hospital for Neurology and Neurosurgery
  • London, United Kingdom
    • St. Mary's Hospital, Imperial College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: BlueWind Medical
• Investigators: Principal Investigator: John Heesakkers, MD, Principal Investigator

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: June 17, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: CP-03-001