Medical Device

Artificial Urethral Sphincter.

Description of the Medical Device

Artificial Urethral Sphincter (AMS 800^®) is consisted of three parts, including artificial sphincter made of silicide. This artificial sphincter is a bag that can be filled with water with the size of a watch belt. The second part is a small sphere that contains saline solution. The third part is the switch. The procedure is to put the artificial sphincter around the bulbous urethra, place the sphincter in the lower abdomen, put the switch in the scrotum and finally connect these three parts. Urination termination occurs when the switch is pressed to fill the artificial sphincter with water to close up the urethra.

Use

• Urinary incontinence caused by congenital hypoplasia of urethral sphincter.
• Urinary incontinence caused by urethral sphincter injuries from surgery or trauma.
• Urinary incontinence due to neurotic urethral sphincter function deficit.

Possible Side Effects

• Artificial urethral sphincter dysfunction (5-16%).
• Relapse of urinary incontinence (3.5-10%).
• Bladder irritation (2.4-10%).
• Infection (1.8-11.6%).
• Urethral corrosion (1-8.1%).
• Pain (7.1%).
• Slow wound healing (5.9%).
• Other uncommon complications: scrotal edema, urinary retention, urethral fistula, blood clot, etc.

Post Surgery Care

• Keep the wound dry to avoid infections.
• Start using the artificial urethral sphincter in 3-6 weeks after the surgery when the tissues heal. The artificial sphincter sleeve is empty when implanted and will automatically be filled with water when the switch is pressed in 3-6 weeks after the surgery. The urethra will be closed in 3-5 minutes.
• This device is a pressure control pump; thus, patients should learn how to use the switch correctly. Consult with your physicians or related care providers after surgery.
• Avoid placing objects in the urethra, such as catheter. Artificial urethral sphincter needs to be relaxed and catheter should be placed by physicians.