A randomized, controlled clinical trial of an intravesical pressure-attenuation balloon system for the treatment of stress urinary incontinence in females

Aims: Evaluate the efficacy, safety, and tolerability of a novel pressure-attenuation balloon for the treatment of female stress urinary incontinence (SUI) using a prospective, randomized, single-blind, multi-center design, evaluated at 3 months. Methods: Sixty-three females with SUI were randomized 2:1 to treatment with a balloon (N=41) or sham procedure (N=22). The sham (control) entailed the same procedure without the deployment of a balloon. Endpoints were evaluated at 3 months and included a composite endpoint that required both 10 point increase in the 22-item Incontinence Quality of Life Survey (I-QOL) and 50% decrease in provocative pad weight. Additional endpoints included incontinence episode frequency, and PGII assessment. Results: In an ITT analysis, 63% of women in the treatment group achieved the composite endpoint, compared to 31% in the Control Group (P=0.0200). In a per protocol analysis, 81% of women in the treatment arm had a 50% decrease in pad weight test vs. 45% in the Control Group (P=0.0143); 41.6% of the treatment patients were dry on pad weight test (1gram) vs. 0% in the Control Group (P