FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that two abstracts have been accepted for presentation at the International Urogynecology Association(IUGA) annual meeting being held June 9-13th, at the Acropolis Convention Center, in Nice, France.
On Saturday, June 13 at 8:45 AM, Professor Jean-Jacques Wyndaele will present three and six month results of the European multicenter randomized controlled trial of the Vesair® Bladder Control System which was conducted at seven European Centers of Excellence. Three month data from the SOLECT Trial had recently been published online in The Journal of Neurourology and Urodynamics. This study is the second randomized controlled trial that demonstrates safety and effectiveness of the Vesair Balloon. Trial sites included: Universitair Ziekenhuis Antwerpen, Universitair Ziekenhuis Brussel, Universitair Ziekenhuis Gent, Academisch Ziekenhuis Maastricht, Catharina Ziekenhuis Eindhoven, Universita di Roma Campus Bio-medico and Università Degli Studi Di Napoli “Federico II” To review the published study results, go to: http://onlinelibrary.wiley.com/doi/10.1002/nau.22708/abstract
Additionally, on June 11th at 2:24 pm, Dr. Kurt McCammon will present a poster on the mechanism of action of the Vesair® Bladder Control System. Dr. McCammon will discuss the physics behind pressure attenuation of transient pressure spikes in a simulated bladder to prevent leakages caused by stress urinary incontinence, a novel concept now made possible by the Vesair® Bladder Control System. Dr. McCammon is from Norfolk, Virginia and is one of 20 Principal Investigators currently enrolling patients in Solace’s third randomized controlled trial of Vesair. “As Urologists, we understand the cause of SUI is multi-faceted with the primary component of the problem being a rise in bladder pressure when women exercise, laugh, cough, or sneeze. By reducing increases in pressure with the use of an air filled balloon floating in the bladder and acting like a “shock absorber,” the urine leakage event is reduced or prevented. Having a compelling treatment option that can be performed in an outpatient clinic without anesthesia, and removable at anytime, will be a welcomed development for the nearly 30 million women throughout the world whose quality of life is impacted by SUI,” said Kurt McCammon, M.D.
To learn more about the Vesair Bladder Control System and to meet with Company representatives, please visit Booth #41 at the IUGA Conference.
About Stress Urinary Incontinence (SUI) and the Vesair Bladder Control System
Women with SUI typically experience transient increases in intravesical pressure during physical movement, for example coughing, laughing, sneezing, or during exercise. When this increased bladder pressure exceeds the ability of the urethral sphincter to withstand pressure, leakage occurs. Unlike currently available SUI treatments that focus on improving the urethral closure forces, the Vesair Bladder Control System is designed to reduce rapid increases in bladder pressure through the placement of a compressible air-filled balloon in the bladder. The balloon acts like a “shock-absorber” to slow rapid changes in pressure and reduce leakage. The uninflated balloon is placed into the bladder through the urethra and subsequently inflated. Balloon placement is performed in an in-office procedure that does not require anesthesia. The Vesair Bladder Control System is not for sale in the United States and has CE mark approval for distribution within the European Union (EU).
About Solace Therapeutics, Inc.
Solace Therapeutics is an emerging women’s health company focused on a revolutionary non-surgical office-based treatment for symptoms of female stress urinary incontinence. SUI, the most prevalent form of incontinence among women, affects an estimated 30 million adult women globally. These women choose to manage their SUI by utilizing absorbent products such as protective pads versus seeking medical help. Solace is dedicated to improving the quality of life for women whose daily life is disrupted by their incontinence. Patient enrollment is underway in a third randomized controlled trial, the SUCCESS clinical trial, in 20 centers throughout the US. Data from these trials will support the application for FDA clearance, third party reimbursement and patient adoption. Please visit www.solacetx.com to learn more about the Company or visit www.stopsui.com to learn more about the SUCCESS trial. Results of the Company’s first randomized controlled trial were published in the Journal of Urology in December 2013. To review the prior published study, visit http://www.jurology.com/article/S0022-5347(13)04659-4/abstract.