Medical device firm Solace Therapeutics has completed enrollment of patients in the stress urinary incontinence control efficacy and safety study (SUCCESS) of the Vesair Bladder Control System.
The SUCCESS trial is a single blind, randomized and controlled study, which enrolled 220 subjects at 20 centers across the US.
The company has designed Vesair Bladder Control System to reduce rapid increases in bladder pressure through the placement of a compressible air-filled balloon in the bladder.
The uninflated balloon will be placed into the bladder through the urethra and subsequently inflated. Balloon placement will be carried out as an in-office procedure, which does not require anesthesia.
Solace Therapeutics president and CEO Bill Gruber said: "I am thrilled with the effort of our clinical sites to achieve this milestone so quickly.
"Completing enrollment sooner than forecasted will enable Solace to accelerate its submission to FDA to commercialize the Vesair Bladder Control treatment as soon as possible."
The company said that the trial is the firm’s third and largest randomized controlled study, which is being conducted based on the FDA investigational device exemption (IDE) approval.
The Vesair Bladder Control System received CE mark approval to market within the European Union (EU), while it is not for sale in the US.