BlueWind Medical System for the Treatment of Patients With OAB

Over Active Bladder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299544
• Other study ID #: CP-03-001
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2018
• Source: Rainbow Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Over Active Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BlueWind Medical

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events	Incidence of serious adverse events system and or procedure related	6 months
Primary	Incidence of serious adverse events (amended)	Incidence of serious adverse events system and or procedure related (amended)	36 months