BLUEWIND OAB
Research type
Research Study
Full title
Safety and Performance of the BlueWind System for the treatment of patients with overactive bladder (OAB)
IRAS ID
166186
Contact name
Sohier Elneil
Contact email
Sponsor organisation
BlueWind Medical Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 18 days
Research summary
BlueWind OAB, is a prospective, observational, self-controlled study for 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. Up to twenty implanted de novo patients and up to twenty implanted prior PTNS patients, will be implanted. The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence was set up to determine the safety and performance of the BlueWind Medical System for the treatment of OAB.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
14/NW/1506
Date of REC Opinion
28 Jan 2015
REC opinion
Further Information Favourable Opinion