Solace Therapeutics’ WomanCare has enrolled its first patient in the VESAIR Clinical Trial to test the safety and efficacy of the Vesair Bladder Control Balloon procedure.
The Vesair Bladder Control System is a technology that addresses an underlying cause of stress urinary incontinence (SUI) with a non-surgical substitute to involuntary urinary leakage.
Women with SUI experience sudden increases in bladder pressure during physical movement such as coughing, laughing, sneezing, or during exercise.
Leakage happens when bladder pressure exceeds the ability of the urethral sphincter to withstand pressure.
Setting itself apart from the currently available SUI treatments that work on improving urethral closure force, Vesair Bladder Control System reduces rapid increases in bladder pressure through the placement of a compressible air-filled balloon in the bladder.
The small, lightweight balloon that floats within the urinary bladder can potentially eliminate or reduce involuntary urinary leakage.
It serves as a shock absorber to lower temporary pressure changes in the bladder that lead to urinary leakage.
The VESAIR trial is being carried out in several clinics in the US.
VESAIR Clinical Trial principal investigator Randall Kahan said: “I am delighted to be participating in the VESAIR Clinical Study. SUI is not life-threatening, but if left untreated, it can greatly diminish a woman’s quality of life.
“Having a non-surgical option would be a great alternative for the nearly one in two women over the age of 50 who suffer from this condition.”
The balloon placement procedure involves uninflated balloon being placed into the bladder through the urethra and then inflated. The placement can be done in an in-office procedure that does not require anaesthesia and can be deflated and removed if needed.