The SUCCESS trial is a phase III study of the Vesair® balloon in the United States for female stress urinary incontinence (SUI). The purpose of this manuscript is to present the 3 month primary efficacy and tolerability outcome data.
The SUCCESS trial is a multi-center, prospective, single blind, randomized, sham-controlled study. Subjects were randomized on a 2.33:1 basis to either Vesair balloon placement or placebo. The primary efficacy endpoint was a composite of both a >50% reduction from baseline on 1 h provocative pad weight test and a ≥10-point improvement in symptoms on the Incontinence Quality of Life Survey (I-QOL) questionnaire assessed at the 3 month study visit.
A total of 221 subjects were randomized, including 157 treatment arm subjects and 64 controls. The 3 month composite primary efficacy endpoint was achieved in 42.1% of treatment group subjects compared with 28.1% of controls on intention-to-treat analysis (p = 0.046). Treatment arm subjects were significantly more likely to report at least a 50% reduction in incontinence frequency on 7-day voiding diary (55.2% vs 32.3%, P = 0.002, ITT) and more commonly reported their incontinence was improved on Patient Global Impression of Improvement in Incontinence (PGI-I) at 3 months compared with controls (58.0% vs 37.7%, P = 0.007, ITT). No device- or procedure-related serious adverse events nor unanticipated adverse events were reported and no cases of urinary retention were observed. All adverse events fully resolved following balloon removal.
In this phase three trial, the Vesair intravesical balloon achieved 3 month primary and secondary endpoints both objectively and subjectively.
Neurourology and urodynamics. 2017 Nov 02 [Epub ahead of print]
Kurt McCammon, Karny Jacoby, Susan Kalota, Jeffrey Snyder, Kevin Cline, Kaiser Robertson, Charles Rardin, Randall Kahan, Lonny Green, Jack Zuckerman, Eric Rovner
Urology of Virginia, Virginia Beach, Virginia., Integrity Medical Research, Mountlake Terrace, Washington., Urological Associates of Southern Arizona, Tucson, Arizona., Genitourinary Surgical Consultants, Denver, Colorado., Regional Urology Associates, Shreveport, Louisiana., Chesapeake Urology Associates, Glen Burnie, Maryland., Women & Infants Hospital of Rhode Island, Providence, Rhode Island., WomanCare, Arlington Heights, Illinois., Virginia Women's Center, Richmond, Virginia., Naval Medical Center, San Diego, California., MUSC Department of Urology, Charleston, South Carolina.