Uromedica has commenced the FDA Investigational Device Exemption (IDE) study of its Adjustable Continence Therapy (ACT) to treat female Stress Urinary Incontinence (SUI).

SUI is a condition characterised by accidental leakage of urine, which may occur when sneezing, coughing, or other physical activity.

ACT is post-operatively adjustable, minimally invasive outpatient procedure. The device comprises two small silicone balloons connected with tubing to a filling port, making it adjustable after implantation without further surgery.

It protects against accidental urine leakage, as the balloons are surgically placed next to the bladder and the ports are placed underneath the skin for adjustment in future.

Uromedica president and CEO Timothy Cook said: “Uromedica is very pleased to have begun our ACT trial. We are fortunate to be working with highly trained and skilled surgeons in a number of premier academic Urologic and Urogynecologic practices.”

The US regulatory agency has allowed the medical device maker to enrol 167 patients for the IDE study at up to 11 sites across the US.

The investigational study aims to evaluate the safety and efficacy of ACT in women suffering from moderate or severe SUI, and follow-up for 12 months.

Provocative pad weight test will be primary clinical endpoint of the study.

Creighton University in Omaha, Nebraska, urology department chairman and urologist Michael Feloney performed the first ACT implantations in early February 2021.

Feloney said: “ACT offers a unique approach to the management of female stress urinary incontinence. It is exciting to be participating in this FDA trial at Creighton University Medical Center.

“I am confident that ACT will be similar to ProACT in providing relief for my patients suffering from stress urinary incontinence.”

Furthermore, Uromedica’s adjustable continence therapy, dubbed ProACT, was approved by the US FDA in 2015, for the treatment of SUI in men after prostate surgery.