Solace Therapeutics today released data from a trial of its Vesair bladder control device, touting that the study met its endpoints “with statistical significance.”
The Framingham, Mass.-based company’s Vesair bladder control device is comprised of a compressible air-filled balloon which acts as a “shock-abosrber” to slow rapid chanes in pressure that can cause Stress Urinary Incontinence.
Solace Therapeutics claims that data from the 221-patient randomized controlled study demonstrates statistical significance when comparing subjects treated with the device to those who underwent sham treatment with at least a 50% reduction in urine leakage. Data also indicates a 10 point improvement in quality of life scores, the company said.
“The results from this study are consistent with the results from the prior two studies and suggest that the Vesair Bladder Control System may be an alternative therapy for women who are not interested in surgery or that would like to reduce their reliance on absorbent pads to manage their SUI,” study principal investigator Dr. Eric Rovner of Charleston, S.C.’s MUSC said in a press release.