FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., today announced that data from a multicenter 166 patient randomized controlled study has been published in the December issue of the Journal of Urology. The study demonstrates the safety and effectiveness of limiting rapid pressure changes within the bladder to reduce symptoms of Stress Urinary Incontinence (SUI).
Composite end point results (pad weight reduction and quality of life improvement) from this trial showed statistically significant benefit when compared to a sham therapy. The percentage of patients in this study with a greater than 50% decrease in incontinence episode frequency (65.5% treatment vs. 31.3% control) compared favorably to reported results for Botox for overactive bladder (57.5% treatment vs. 28.9% control). “The results from this study suggest that a reversible office procedure to treat SUI may provide a clinically valuable option for those female patients that are either not candidates for surgery or prefer to explore a non-surgical option to treat their SUI symptoms prior to surgery.” said Roger Dmochowski, M. D., Department of Urologic Surgery, Vanderbilt University, Nashville, Tennessee.
Women with SUI typically experience transient increases in intravesical pressure during physical movement including coughing, laughing, sneezing, or during exercise. When this increased bladder pressure exceeds the ability of the urethra to withstand pressure, leakage occurs. Unlike currently available SUI treatments that focus on improving the urethral closure forces, Solace reduces bladder pressure increases with the placement of a compressible air-filled balloon in the bladder. The balloon acts like a “shock-absorber” to prevent rapid changes in pressure and reduce leakage. The un-inflated balloon is placed into the bladder through the urethra and filled in an office procedure without the need for anesthesia. When necessary, the balloon is deflated and removed in a similar office procedure.
It is estimated that nearly one in three women suffer from SUI, which impacts quality of life and is a substantial economic burden if untreated. “Despite a wide range of current treatment options, there remains a significant unmet clinical need for a non-surgical treatment that is effective, reversible, safe, relatively inexpensive, and has low morbidity.” said Eric Rovner, M.D., Department of Urology, Medical University of South Carolina, Charleston, SC.
Based on the results of this study, device improvements have been completed to further improve efficacy, safety, and to permit the Solace Balloon to remain in the patient for up to 1 year before replacement. A multicenter, randomized controlled study in Europe is currently enrolling patients to collect data to support third party reimbursement and patient adoption.
The Journal of Urology is the first peer-reviewed publication to publish study results on the safety and effectiveness of intravesical pressure attenuation. To review the published study, visit http://www.jurology.com/article/S0022-5347(13)04659-4/abstract.
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. Most women believe that it is a normal part of aging. 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 Solace.