neurological or connective tissue condition or disease affecting bladder function Home; Study Search; . PHOENIX--(BUSINESS WIRE)--Valley Urogynecology Associates, Ltd has enrolled their first patient in the VESAIR Clinical Trial. Source: Business Wire, March 1, 2017 Post navigation The Vesair Bladder Control System is a technology that addresses an underlying cause of stress urinary incontinence ( Sui) with a non-surgical substitute to involuntary urinary leakage. Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress. Balloon placement is performed as an in-office procedure that does not require anesthesia. You also have the option to opt-out of these cookies. muscle training or surgery, said Denise Elser, MD with the Womens Who will you tell? This website does not accept advertising. The Vesair Bladder Control System is a non-surgical alternative to involuntary urinary leakage. 37th Annual AUGS Meeting in Denver, Colorado September 28-30th. Health Institute of Illinois. You have reached the maximum number of saved studies (100). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Talk with your doctor and family members or friends about deciding to join a study. We also use third-party cookies that help us analyze and understand how you use this website. System. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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). pressure during physical movement; for example, when coughing, laughing, 12 months and is replaced annually. Unlike currently available SUI treatments that focus on The purpose of the study is to evaluate the safety and effectiveness of an investigational device called the Vesair Bladder Control System in managing your stress urinary incontinence (SUI) Female Urinary Urge Incontinence The video presentation entitled 12 Month In-Dwelling Intravesical on the healthcare delivery system if left untreated. Solace TherapeuticsNicole M. Shugrue, 508-283-1200 Ext. Device: Solace Bladder Control (Vesair . Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc History of cancer of the urinary tract History of any cancer within the past two years (excluding non-melanoma skin cancers) History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers) Immunologically suppressed or immunocompromised It is for investigational use only. occurs. About Stress Urinary Incontinence and the Vesair Bladder Control Necessary cookies are absolutely essential for the website to function properly. The Simon Foundation website content is for informational purposes only and does not replace advice from health care professionals. occur in nearly 40% of all men who have prostate surgery. The balloon is intended to remain in the bladder for up to The Vesair Bladder Control procedure: Is intended to be performed in a physician's office May not require the use of pain medication or anesthesia Summary. The Vesair Bladder Control System is a novel treatment option that is intended to treat stress urinary incontinence(SUI), is performed in a physician's office, and is completely reversible. All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually. Webmaster at: webmaster@simonfoundation.org, Copyright 2022 The Simon Foundation for ContinenceAll Rights Reserved. their incontinence. Balloon bladder. Analyze clinical trials with filters and metrics. Find a Trial The Vesair Bladder Control Balloon floats at the top of the bladder and acts as a shock absorber to reduce intra bladder pressure during laughing . CD 1009 Rev A Page 1 of 44 23OCT2018 Vesair Balloon Confirmatory Trial (VECTOR) Use of the Next Generation Vesair Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women. Data will be forthcoming. frequency, and improved quality of life. . The Vesair Balloon Delivery System is not currently available in the U.S. SUI . Brief Summary: Single arm study of the Vesair Balloon in postmenopausal women. Study Description Go to Brief Summary: Multicenter, prospective, single-arm study to assess the safety and efficacy of the Vesair Bladder Control treatment in post-menopausal women with Stress Urinary Incontinence (SUI) with follow-up at 1, 3 and 12 months. Elser, MD will be presenting a video presentation of the removal and "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. Links; conversations; . Improvement in I-QOL score (0-100 point scale, 100 being the best outcome), Reduction in episode frequency as reported on a 7 day diary, Significant Improvement per PGI-I (response of very much better or much better on 7 point scale). All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually. This category only includes cookies that ensures basic functionalities and security features of the website. If you continue using our website, we'll assume that you are happy to receive all cookies on this website. participate in the SUCCESS Trial. This website uses cookies to improve your experience while you navigate through the website. Privacy policy. Vesair Continued Access Trial: Use of the Vesair Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. 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. The balloon is designed to eliminate or reduce involuntary urinary leakage. improving the urethral closure forces, the Vesair Bladder Control It is mandatory to procure user consent prior to running these cookies on your website. twelve and twenty-four month data from the SOLECT Trial which is the About Stress Urinary Incontinence and the Vesair Bladder Control System. Millions live with bladder control problems. The. Detailed Description: All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually. Please remove one or more studies before adding more. Solace is dedicated 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 SUI. anesthesia. The product is a small, lightweight device (about the size of a quarter) that floats within the urinary bladder. investigators for the multicenter SOLECT Trial. Read more. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Single arm study of the Vesair Balloon in postmenopausal women. 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. This study is an IDE study to evaluate the safety and performance of the Vesair Bladder Control System and is intended to support FDA approval. The video depicts the simplicity of the removal and replacement of the The balloon acts like a shock absorber to slow rapid changes I was delighted to through the placement of a compressible air-filled balloon in the Prof. De Wachter, from AV-1015 Rev Q References Privacy Policy, Site Design and Development by Conlega Design. The Vesair Bladder Control System is for investigation use only in the United States and has CE mark approval for distribution within the European Union. Is intended to be performed in a physicians office, May not require the use of pain medication or anesthesia, Is 100% reversible and does not preclude patients from any other future treatment option, Does not limit normal daily activities immediately following the procedure. Efficiently skim through many trials at a time. experience clinically relevant reduction of urine leakage, episode The uninflated balloon is placed into 165Vice Video: Vesair Bladder Control System The latest results on the balloon device (Vesair Bladder Control System, Solace Therapeutics) were reported by investigators from the SOLECT trial at the AUA annual meeting in San Diego. Overview. We use them to give you the best experience. The Vesair Bladder Control procedure adds compliance to the bladder by reducing these rapid pressure changes. Home; Study Search; Study Details From Other Databases The Vesair Bladder Control procedure adds compliance to the bladder by reducing these rapid pressure changes. FRAMINGHAM, Mass.--(BUSINESS WIRE)--Solace Therapeutics, Inc., announced today that Stefan De Wachter, MD, Universitair Ziekenhuis Antwerpen in Edegem, Belgium, is one of several The Vesair Bladder Control Balloon is The uninflated balloon is placed into the bladder through the urethra and subsequently inflated. Companys second Randomized Controlled Trial of the Vesair Bladder Read more. a 10-point improvement in their I-QOL score and 85% having a >50% reduction in pad weight. The Vesair Bladder Control System is for investigation use only in the United States and has CE mark approval for distribution within the European Union. It is for investigational use only. SUCCESS Clinical Trial Protocol will be presented by Denise Elser, MD. Study Type: Interventional; Study Design. An Evaluation of the Vesair Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women : Secondary IDs: Study Status. replacement of the Vesair Bladder Control Balloon during the Air-Filled Balloon Removal Followed by New Balloon Replacement Per the The long-term results presented by Stefan De Wachter, MD, PhD include The Vesair Bladder Control Balloon is a promising, non-invasive and reversible therapy for women seeking an alternative to conventional treatment options such as pelvic floor muscle training or surgery," said Denise Elser, MD with the Women's Health Institute of Illinois. placement is performed as an out-patient procedure that does not require (Clinical Trial), Subject and assessor blinded to randomization result, An Evaluation of the Vesair Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women, 18 Years and older (Adult, Older Adult), San Diego, California, United States, 92130, Temecula, California, United States, 92592, Westlake Village, California, United States, 91361, Farmington, Connecticut, United States, 06032, Meridian Clinical Research / Urological Associates of Savannah, Arlington Heights, Illinois, United States, 60004, Shreveport, Louisiana, United States, 71106, Owings Mills, Maryland, United States, 21117, Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States, 02210, Garden City, New York, United States, 11530, Premier Medical Group of the Hudson Valley, Poughkeepsie, New York, United States, 12601, Raleigh, North Carolina, United States, 27612, Philadelphia, Pennsylvania, United States, 19041, Providence, Rhode Island, United States, 02903, Virginia Beach, Virginia, United States, 23462, Kirkland, Washington, United States, 98034. Actual Primary Completion Date : Jan 15, 2019. The Vesair Bladder Control Balloon floats at the top of the bladder and acts as a shock absorber to reduce intra bladder pressure during laughing . . The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females. The reduction in tissue elasticity, sometimes referred to as compliance, can result in significant and rapid increases in pressure within the bladder. . Enrollment was completed in August 2015 comprising of 221 patients at 20 centers. Choosing to participate in a study is an important personal decision. Home; Study Search; . Women with SUI typically experience transient increases in intravesical pressure during physical movement, for example coughing, laughing, sneezing, or during exercise. 10-Point improvement in their I-QOL score and 85 % having a & gt ; 50 reduction... 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