Bladder
ACT® INTERNATIONAL
Adjustable Continence Therapy
Caution – The Uromedica ACT system is an INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE. The ACT System is not available for sale in the United States.
The Uromedica ACT system has received European CE Mark approval, Canadian licensing, and is listed on the Australian Register of Therapeutic Goods for treatment of stress urinary incontinence and is available for sale in Europe, Canada and Australia.
WHAT IS ACT?
The ACT system is implanted within your body to assist in the protection of accidental leaking of urine. This can occur during everyday activities such as coughing, sneezing or physical activity. Once implanted, only you will know it is there. While other devices require surgery for an adjustment, ACT can be adjusted in a brief office visit to better match your individual needs. ACT can be inflated, deflated or removed by your doctor if necessary. ACT is also a passive therapy meaning there is no need for you to manipulate the device at any time.
The ACT device consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure of approximately 30 minutes, the balloons are surgically placed on either side of the bladder neck. The fluid-filled balloons provide pressure and support which protects against accidental leaking of urine that can occur during a sneeze, cough, or physical activity. When you need to urinate, it will only require a normal amount of bladder effort. The balloon size can be altered through a small port located underneath the skin of the labia majora.
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IMPORTANT SAFETY INFORMATION
The ACT System is indicated for the treatment of moderate to severe stress urinary incontinence in adult females with intrinsic sphincter deficiency (ISD) who have failed to respond adequately to non-surgical therapy or adult females who have failed another surgical therapy.
The potential risks with the ACT implant procedure are similar to those for other surgical treatments for stress urinary incontinence. These include but are not limited to tissue perforation, device migration, post-operative urgency, frequency or retention, tissue erosion/infection at the implant site, device failure and non-response to treatment. Women who are sexually active or have ISD due to a neurogenic cause may have worse functional results or greater incidence of complications.
If an infection occurs at the implant site, it can be treated with antibiotics. If a more serious side effect occurs (e.g., perforation, migration, erosion), ACT can be completely removed in an office setting.
Your doctor is your best source for information on the risks and benefits of ACT. Talk to your doctor for a complete listing of risks, warnings and important safety information.
