Device shows safety, efficacy in reducing SUI

November 18, 2013

An investigational minimally invasive device was found safe and effective in limiting rapid pressure changes within the bladder to reduce symptoms of stress urinary incontinence, the authors of a recently published trial reported.

An investigational minimally invasive device was found safe and effective in limiting rapid pressure changes within the bladder to reduce symptoms of stress urinary incontinence, the authors of a recently published trial reported.

The device, known as Solace (Solace Therapeutics, Framingham, MA), reduces bladder pressure increases with the placement of a compressible air-filled balloon in the bladder. The balloon is designed to prevent rapid changes in pressure and reduce leakage.

In the study, 166 female patients with stress incontinence were randomized 2:1 to treatment with the pressure attenuation device or a sham procedure. Composite endpoint results (pad weight reduction and quality of life improvement) showed statistically significant benefit when compared to sham therapy (J Urol 2013; 190:2243-50). The percentage of patients with a greater than 50% decrease in incontinence episode frequency (65.5% treatment vs. 31.3% control) compared favorably to reported results for onabotulinumtoxinA (Botox) for overactive bladder (57.5% treatment vs. 28.9% control).

“The results from this study suggest that a reversible office procedure to treat SUI may provide a clinically valuable option for those female patients that are either not candidates for surgery or prefer to explore a non-surgical option to treat their SUI symptoms prior to surgery,” said co-author Roger Dmochowski, MD, of Vanderbilt University, Nashville, TN.

During the Solace procedure, the uninflated balloon is placed into the bladder through the urethra and filled in an office procedure without the need for anesthesia. When necessary, the balloon is deflated and removed in a similar office procedure.

Based on the results of this study, Solace Therapeutics said device improvements have been completed to further improve efficacy, safety, and to permit the Solace Balloon to remain in the patient for up to 1 year before replacement. A multicenter, randomized controlled study in Europe is currently enrolling patients to collect data to support third-party reimbursement and patient adoption.

The study was supported by Solace Therapeutics. Dr. Dmochowski reported a financial interest and/or other relationship with Allergan, Medtronic, and Contura. 

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