US-based Solace Therapeutics has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Guardian Urethral Sheath and investigational device exemption (IDE) approval to initiate the SUCCESS clinical trial.
The SUCCESS clinical trial, the third prospective, multicentre, randomised clinical trial is designed to assess the safety and effectiveness of the Solace Bladder Control System in 20 sites across the US.
Solace Bladder Control System is a non-surgical alternative to involuntary urinary leakage.
Solace Therapeutics president and CEO Bill Gruber said: "We are encouraged by the patient outcomes with the Solace Bladder Control System in previous and ongoing clinical studies, and we look forward to working with the FDA to bring this breakthrough technology to the 15 million women with SUI in the United States.
"Women need cost-effective treatment alternatives for SUI that don’t require surgery and are reversible at any time."
SUI is the most prevalent form of incontinence among women and affects an estimated 140 million women worldwide.The condition involves the bladder’s inability to store urine during normal everyday physical activities without sudden increases in bladder pressure.
The company said that the Solace Bladder Control Balloon is a small, lightweight device that floats within the urinary bladder.
The balloon is designed to reduce involuntary urinary leakage and it acts as a ‘shock absorber’ to reduce the temporary pressure changes in the bladder that cause urinary leakage.
Solace Bladder Control System received the CE Mark and comprises the Solace Bladder Control Balloon, Guardian Urethral Sheath and delivery and removal devices.
The company said that patient enrolment is complete in a randomised, controlled, post-market trial in Europe.
The Guardian Urethral Sheath is a device used to simplify access into the bladder through its natural orifice, the urethra, while the sheath permits delivery and removal of the Solace Bladder Control Balloon and can also be used during any routine cystoscopic procedure.