Antwerp, Belgium—After meeting its primary endpoint at 3 months in a prospective, randomized, sham-controlled clinical trial, an intravesical pressure-attenuation balloon (Vesair Bladder Control System, Solace Therapeutics) for treatment of female stress urinary incontinence (SUI) demonstrated durable efficacy and safety after 12 months of follow-up.
The latest results on the balloon device (Vesair Bladder Control System, Solace Therapeutics) were reported by investigators from the SOLECT trial at the AUA annual meeting in San Diego.
“The balloon is intended to be removed and replaced every 12 months, and the study has a planned duration of 3 years. While we look forward to assessing the longer-term efficacy and safety of this novel treatment for SUI, the available data support its consideration as an alternative for patients who fail conservative treatment and are unfit for or choose not to undergo surgery,” said Stefan De Wachter, MD, PhD, SOLECT trial investigator and professor of urology, Antwerp University Hospital, Belgium.
Anecdotally, Dr. De Wachter told Urology Times that some patients have already reached the 3-year visit and have been disappointed when told they must exit the study and cannot receive another balloon for their SUI.
The balloon is placed into the bladder in a cystoscopic procedure. It comes deflated and pre-inserted inside the tip of a 19F delivery system. Once inserted into the bladder, the balloon is filled with a compressible gas. It is thought to relieve symptoms of SUI by acting as a hydraulic “shock-absorber,” reducing transient spikes in intravesical pressure that occur with coughing or other actions.
The SOLECT trial randomized 63 women 2:1 to insertion of the balloon or a sham procedure. Women originally randomized to the control group were eligible to receive the balloon after the 3-month visit.
Patients were eligible for participation in the SOLECT trial if they had SUI for ≥12 months and failed prior noninvasive treatment. In addition, they had to have a positive provocative pad weight test ≥5 grams, Valsalva leak point pressure ≥60 cm H2O, and a baseline Incontinence Quality of Life survey (I-QOL) score ≤80. Presence of detrusor overactivity or interstitial cystitis were key exclusion criteria.
Data from the 12-month visit were available for 23 women who at baseline had a mean pad weight of 15.2 grams, mean I-QOL score of 56.0, and mean daily incontinence frequency of 3.1.