FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, a medical technology company focused on developing breakthrough treatments for urinary incontinence, today announced that it has completed enrollment in the SUCCESS (Stress Urinary inContinence Control Efficacy and Safety Study) Clinical Trial ahead of schedule due to overwhelming patient interest.
According to the Company, nearly 105,000 women visited www.stopsui.com to learn about the Vesair Bladder Control procedure and trial eligibility. The SUCCESS trial is a single blind, randomized, controlled study of 220 subjects enrolled at 20 centers across the US. This pivotal trial is being conducted under an Investigational Device Exemption (IDE) granted by FDA. This is the third and largest randomized controlled trial undertaken by the Company. “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,” said Bill Gruber, Solace’s President and CEO.
On the same day the Company completed enrolling patients into the SUCCESS trial, Jeffrey A. Snyder, M.D., reported that he was delighted to see the first enrolled patient return for her 12 month follow-up visit and continue her participation in the trial. Dr. Snyder is a urologist at Genitourinary Surgical Consultants in Denver, Colorado, and has participated in both of the Company’s US clinical trials. Karny Jacoby, M.D., with Integrity Medical Research in Seattle, Washington said, “With nearly 15 million women dealing with bladder leaks caused by SUI and with so few desirable treatment options available for these women, it was no surprise to see such favorable interest in the trial.” Dr. Jacoby is one of 20 Principal Investigators for the SUCCESS Clinical Trial.
About Stress Urinary Incontinence and the Vesair Bladder Control System
Women with SUI typically experience transient increases in intravesical pressure during physical movement, for example when coughing, laughing, sneezing, or during exercise. When this increased bladder pressure exceeds the ability of the urethral sphincter to withstand it, 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 as 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 medical technology company primarily focused on a revolutionary non-surgical office-based treatment for symptoms of stress urinary incontinence. SUI affects nearly 30 million women globally and can occur in nearly 40% of all men who have prostate surgery. The cost of caring for patients with incontinence is a significant economic burden on the healthcare delivery system if left untreated. Solace is dedicated to developing value-driven innovations that can help healthcare providers improve patient outcomes, reduce procedure costs, and enhance the quality life for people whose daily life is disrupted by their incontinence. Data from the SUCCESS clinical trial and prior randomized controlled 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.