McCammon K, et al. - Authors sought to illustrate the 3-month primary efficacy and tolerability outcome data of the Vesair balloon placement for female stress urinary incontinence in the United States. Both objectively and subjectively, 3-month primary and secondary endpoints were achieved via the Vesair intravesical balloon.

Methods

• The design of this SUCCESS trial was a multi-center, prospective, single blind, randomized, sham-controlled study.
• Enrollees were allocated on a 2.33:1 basis to either Vesair balloon placement or placebo.
• 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 comprised of the primary efficacy endpoint.

Results

• This trial recruited 221 individuals, including 157 treatment arm subjects and 64 controls.
• Herein, 42.1% of treatment group subjects achieved the 3 month composite primary efficacy endpoint, in contrast to 28.1% of controls on intention-to-treat analysis (p=0.046).
• A markedly greater tendency was found for at least a 50% reduction in incontinence frequency on 7-day voiding diary (55.2% vs 32.3%, (p=0.002, ITT) among the treatment arm candidates.
• They commonly reported an improvement in their incontinence exhibited via the Patient Global Impression of Improvement in Incontinence (PGI-I) at 3 months compared with controls (58.0% vs 37.7%, (p=0.007, ITT).
• The data did not disclose any device- or procedure-related serious adverse events nor any unanticipated adverse events and there were no cases of urinary retention.
• All adverse events fully resolved after the balloon removal.