This study examined the safety and effectiveness of the Vesair balloon procedure in reducing involuntary urine leakage in women with stress urinary incontinence. Researchers concluded that the Vesair balloon procedure is a safe and effective alternative treatment option for stress urinary incontinence.

Stress urinary incontinence can affect quality of life and challenge everyday activities. While many surgical procedures are effective at treating urinary incontinence, these often entail various surgical risks, and may involve a painful recovery. The Vesair balloon procedure is a new type of reversible, non-surgical procedure to help control stress urinary incontinence. The Vesair is a small balloon that is directly inserted into the bladder through the urethra (the urine tract). Increased bladder pressure caused by sudden abdominal stress (like coughing, laughing or sneezing) is absorbed by the Vesair balloon, therefore reducing involuntary urine leakage.

This study included 63 women with stress urinary incontinence. Women were randomly assigned to receive treatment with either the new Vesair balloon procedure or with a sham procedure during which no active treatment was given.

Involuntary urine leakage was significantly reduced with the new Vesair balloon procedure. Analysis showed that 63% of women undergoing treatment with the Vesair balloon achieved a 50% reduction in urine leakage, compared to only 31% of women not receiving active treatment. A test of urine leakage during physical activity showed that 42% of women undergoing treatment with the Vesair balloon achieved continence, while none of the women undergoing sham treatment achieved continence. After 3 months of treatment, women receiving treatment with the Vesair balloon were more likely to report improvements in both urinary symptoms and quality of life.

The Vesair balloon procedure was safe and well-tolerated among women. Some side-effects associated with the procedure included painful urination (reported in 15% of women), blood in urine (reported in 10% of women), urinary tract infections (reported in 7% of women), and localized pain (reported in 5% of women).

The researchers concluded that the new Vesair balloon procedure is a simple, safe and effective treatment option for stress urinary incontinence.

Larger clinical trials, long-term follow-up, and direct comparisons to other standard-of-care procedures, are needed to confirm these preliminary results regarding this new treatment option.