The company began its third randomized controlled trial in the US in August 2014. Enrollment was completed in August 2015 comprising of 221 patients at 20 centers.
This study is an IDE study to evaluate the safety and performance of the Vesair Bladder Control System and is intended to support FDA approval.
Data will be forthcoming.
Solace has completed a 166 patient randomized controlled trial (RCT) in 13 centers around the US.
Solace has also completed enrollment in a 63 patient RCT in 7 centers in Europe. Three month data from the European trial is now published online in The Journal of Neurourology and Urodynamics.
The clinical centers in the
studies included Urologists, Urogynecologists, and Gynecologists. Both studies
were designed to prospectively randomize subjects to a sham or treatment therapy and results validated the safety of the device.
The studies included key subjective and objective outcome measures that compare favorably to other existing non-surgical approaches. The studies reached clinical success with the composite endpoint now recommended in the most recent FDA guidance document.