Female SUI system shows durable efficacy, safety

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 demonstrated durable efficacy and safety after 12 months of follow-up.

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.

Video: Vesair Bladder Control System

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.

Next: Endpoint achieved by 82.6%

Endpoint achieved by 82.6%

A composite endpoint that required a ≥10-point improvement in I-QOL score plus >50% reduction in the provocative pad weight test was used to assess efficacy at 3 months, and it was achieved by 82.6% of the women with the balloon. At 12 months, 76.2% of the 23 women met the composite endpoint criteria, with 77.3% of women achieving a ≥10-point improvement in their I-QOL score and 85% having a >50% reduction in pad weight.

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“An I-QOL improvement of 6 to 7 points is considered clinically significant, and almost half of the women reported being dry,” Dr. De Wachter said.

Adverse events were reported by 14 of the 23 women assessed at 12 months. Gross hematuria was the most common, occurring in six women (26.1%). Balloon deflation, urgency/urge incontinence, and suprapubic discomfort each occurred in three women, and there were two reports each for cystitis, dysuria, and bladder wall irritation. There was one urinary tract infection during the first 12 months of the study and one additional urinary tract infection between months 12 and 24.

Dr. De Wachter said that the hematuria was probably the result of the balloon hitting the bladder wall. He noted that urgency complaints were not unexpected, as two women had mixed urinary incontinence, but urgency in all women responded to anticholinergic therapy.

“Overall, the balloon was very safe. There were no reports of urinary retention, and while some bladder wall irritation was seen on cystoscopy at the time of balloon removal and exchange, there was no edema of the bladder as can be seen with indwelling catheters,” he said.

Examination of removed balloons showed a measurable deposit of <1 mm on three of the devices.

“We would expect to see some deposition on any foreign object left inside the bladder. Encrustation on the balloon was minimal, however, and that is probably because the balloon is a floating dynamic system that changes its shape in response to pressure,” Dr. De Wachter said.

Dr. De Wachter’s travel expenses to the AUA meeting were covered by Solace Therapeutics. Several of his co-authors are investigators for or have another affiliation with Solace.