FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that data from a multicenter 221 patient randomized controlled trial has met study endpoints with statistical significance. Dr. Eric Rovner will be presenting a poster of the results from the SUCCESS Clinical Trial at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting in Scottsdale, Arizona on Thursday, March, 2nd.
This is the Company’s third randomized controlled trial 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 when comparing subjects in the treated group to those who underwent sham treatment with 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 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,” said Eric Rovner, MD, at MUSC in Charleston, SC, and Principal Investigator from one of twenty medical centers throughout the United States that participated in the SUCCESS Trial. Three- and twelve-month results from the SUCCESS trial are currently pending publication.
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 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 during 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 SUI. 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. Please visit www.solacetx.com to learn more about the Company and review results from the first two clinical trials.