Rovner ES, Dmochowski RR, Leach GE, Jayne C, Snyder JA. A Randomized, Controlled Clinical Trial of a Novel Intravesical Pressure Attenuation Device for the Treatment of Stress Urinary Incontinence. Journal of Urology. 2013; 190(6): 2243-2250.
Wyndaele JJ, De Wachter S, Tommaselli G, Angioli R, de Wildt M, Everaert K, Michielsen D, van Koeveringe G. A Randomized, Controlled Clinical Trial of an Intravesical Pressure-Attenuation Balloon System for the Treatment of Stress Urinary Incontinence in Females. Neuro Urol. 2016; 35(2): 252-259
McCammon K, Jacoby K, Kalota S, Snyder J.A., Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-Month Primary Efficacy Data for the SUCCESS Trial; a Phase III, Multi-Center, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence with the Vesair Intravesical Balloon. Neurourology and Urodynamics 2018; 37:440-448
Van Koeveringe G, De Wachter S, Zuckerman J, Tommaselli G, de Wildt M, Everaert K, Michielsen D, Wyndaele JJ. Minimal Device Encrustation on Vesair Intravesical Balloons in the Treatment of Stress Urinary Incontinence: Analysis of Balloons Removed from Women in the SOLECT Trial. Advances in Therapy. July 2017; 34(7);1686-1694, Volume 34, Issue 7, pp 1686-1694
Winkler H, Jacoby K, Kalota S, Snyder J.A., Cline K, Robertson K, Rardin C, Kahan R, Green L, Rovner E, McCammon K. 12-Month Efficacy and Safety Data for the SUCCESS Trial; a Phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the Vesair intravesical balloon. Female Pelvic Medicine & Reconstructive Surgery: September 26, 2017; 24(3);222-231
Dmochowski RR, Rovner ES, Connors KG, Winters JC. Study design and outcomes measures: The influence of composite endpoints and other design variables on outcomes in a study of a novel device for stress urinary incontinence. Neurourology and Urodynamics. 2018;1–9.
The Vesair Balloon Delivery System is not currently available in the U.S. It is for investigational use only.
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