URYX® Urethral Bulking Agent - P030030
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: URYX® Urethral Bulking Agent
Applicant: Genyx Medical, Inc.
Address: 66 Argonaut, Suite 170, Aliso Viejo, CA 92656
Approval Date: December 16, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030030a.pdf
What is it? URYX® is a permanently implanted device used to treat women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles. The device is a chemical solution that is injected into the wall of the urethra near the bladder and solidifies into a spongy material that bulks the wall of the urethra to help prevent uncontrolled urination.
How does it work? Women with stress urinary incontinence tend to experience uncontrolled urination during exercise or certain other body movements. One cause of stress urinary incontinence is a weakness of the urethral sphincter muscles, which help open and close the tube from the bladder that drains urine from the body (urethra). URYX® is intended to keep urine from accidentally leaking out of the bladder in women with poorly functioning urethral sphincter muscles by bringing the walls of the urethra closer together. Using a small tube to view the bladder (cystoscope), the solution is injected into the wall of the urethra. After injection, the solution separates and solidifies into a spongy material that bulks the wall of the urethra.
When is it used? URYX® is used in adult women who have stress urinary incontinence due to poorly functioning urethral sphincter muscles.
What will it accomplish? In a clinical study, approximately 20% of women were dry 1 year after receiving URYX®, and another 30% had fewer episodes of uncontrolled urination (based on physician review of the patient’s voiding diary). Approximately three-quarters of these patients required repeat injection of URYX® to achieve satisfactory results. Common side effects of treatment included urinary tract infection (UTI) in 29% of patients, delayed ability to urinate in 18%, painful urination (dysuria) in 18%, exposed material in the urethra in 16%, feeling of a sudden urge to urinate without incontinence (urgency) in 14%, frequent urination in 13%, symptoms of infection (where a UTI could not be documented) in 11%, bloody urine (hematuria) following injection in 11%, incontinence caused by a sudden urge to urinate (urge incontinence) in 9%, and worsening of pre-existing urge incontinence in 8%.
When should it not be used? The device should not be used in women who:
- have signs of a UTI or other genital or urinary (genitourinary) infection, and
- have thin or weak urethral wall tissue.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030030