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: Coaptite®
Manufacturer: Bioform Medical, Inc.
Address: 1875 South Grant Street, Suite 110, SAN MATEO, CA 94402
Approval Date: November 10, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040047a.pdf
What is it? Coaptite® 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 tooth paste-like gel that is injected into the wall of the urethra near the bladder. After injection, Coaptite® 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 such as sneezing and coughing. One cause of stress urinary incontinence is a weakness of urethral sphincter muscles, which help open and close the tube from the bladder that drains urine (urethra). Coaptite® is intended to prevent urine from accidentally leaking out of the bladder in women with poorly functioning urethral muscles by bringing the walls of the urethra closer together. Using a small tube to view the bladder (cystoscope), the gel mixture is injected into the wall of the urethra. After injection, a part of the gel vanishes in a few months but the solid particles remain to provide for bulking of the urethral wall.
When is it used? Coaptite® 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 34% of women were dry at 1 year after receiving Coaptite® and 58% had slight to significant improvement (improvement includes dry) in their incontinence (based on which activities caused urine leakage). In 10% of women, incontinence worsened. Approximately 63% of women required repeat injections to achieve satisfactory results. In terms of the amount of leakage, 62% had a reduction of = 50% urine leakage after treatment, compared to pretreatment leakage.
What are the risks? An unanticipated side effect noted during the study was dissection of the device through tissue leading to: 1) tissue erosion requiring corrective surgery in one patient, and 2) elevation of the bladder wall causing ureteral obstruction in another patient. Patient’s medical history and improper injection technique may have contributed to these serious side effects.
Common side effects of the treatment included urination difficulty (retention) in 41% patients, blood in urine in 20%, painful urination (dysuria) in 15% patients, urinary tract infection (UTI) in 8%, a feeling of sudden urge to urinate without incontinence (urgency) in 8%, frequent urination in 7%, and incontinence by a sudden urge to urinate in 6%.
When should it not be used? Coaptite® should not be used in patients who have:
- a significant history of urinary tract infections without resolution
- current or acute conditions of cystitis or urethritis
- a fragile urethral mucosal lining
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040047