FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that data from a multicenter 63 patient randomized controlled trial has met study endpoints with statistical significance. Data from this study will be presented by Dr. Gommert van Koeveringe at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting in Scottsdale, Arizona on Saturday, February 28.
This is the Company’s second RCT to evaluate the safety and efficacy of the Vesair Bladder Control System; a novel, office based, reversible treatment designed to reduce or eliminate urine leakage in female patients with Stress Urinary Incontinence (SUI). Study results demonstrated statistical significance of at least a 50% decrease in urine leakage volume and a 10 point improvement in quality of life score in an intent to treat population. “The results from this study suggest that the Vesair Bladder Control System is a clinically relevant treatment option for women who wish to avoid surgery,” said J.J. Wyndaele, PhD., at Universitair Ziekenhuis Antwerpen, Edegem, Belgium. The trial was conducted within seven European Centers of Excellence. 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”. The study has been published online in The Journal of Neurourology and Urodynamics and is the second peer-reviewed publication to publish study results on the safety and effectiveness of intravesical pressure attenuation. To review the published study, go to: http://onlinelibrary.wiley.com/doi/10.1002/nau.22708/abstract.
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. When necessary, the balloon is deflated and removed in a similar in-office procedure. Most women manage their SUI with absorbent pads and are reluctant to undergo surgery for a variety of reasons. “A non-surgical option would be a great alternative for the nearly 1 in 3 women that have SUI and whose lives are disrupted on a daily basis by this treatable medical condition," said Bill Gruber, President and CEO, Solace Therapeutics, Inc.
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 15 million adult women in the U.S. 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. The Company continues to enroll patients in a third randomized controlled trial, the SUCCESS clinical trial, to support FDA approval, 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 RCT 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.