Introduction and objective
The BlueWind Medical Device is a novel miniature, leadless, battery-less, sub-facially implantable tibial neuromodulation system. The implant is wirelessly powered and modulated by an external wearable unit. A Clinician Programmer is used to individually tailor stimulation parameters (i.e., frequency, pulse width and amplitude). A pivotal trial was conducted to evaluate the safety and efficacy of the BlueWind Medical Device for treating Urge Urinary Incontinence (UUI) in women.
Methods
One hundred and fifty-one women with UUI were enrolled in 23 centers in the United States and Europe, for this prospective, single arm, open-label study. Inclusion criteria required at least 9 UUI episodes during a 7-day diary. The device was activated ∼4 weeks after implantation, and the patients performed daily stimulation treatments at home for ∼30 minutes twice daily. Stimulation parameters were individually tailored according to a predefined algorithm per patient sensation and response. Multiple Treatment Programs were provided for patients when needed. Voiding diaries, quality of life and patient satisfaction questionnaires were collected at 6 and 12 months after device activation. The primary safety measure was incidence of Adverse Events (AE) at 12 months post activation. Primary efficacy end point was defined as ≥50% reduction in UUI episodes compared to baseline.
Results
One hundred and fifty-one subjects, mean age 58.8 (SD: 12.5) were implanted. The subjects demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Results are presented based on the intend to treat analysis set with 144 and 140 patients reaching 6- and 12-months post activation, respectively. No device or procedure related Serious Adverse Events (SAE) were reported by 12 months. At 6 and 12 months, 76.4% and 78.4% of the subjects were therapy responders (p<.0001), respectively, with 50% of the subjects dry at 12 months (on 3 consecutive days diary). At 12 months, 84.6% of the patients showed ≥10 points improvement (Minimal Important Difference; MID) in Health Related Quality of Life (p<.0001).
Conclusions
The BlueWind Medical Device has demonstrated an excellent safety profile with no device or procedure related SAEs. Efficacy endpoints were met with high proportion of dry patients, high compliance, and high patient satisfaction.
Source of funding
BlueWind Medical is the Sponsor of OASIS trial
