Urinary Incontinence : Implanted Devices, Surgical Treatments

by Food and Drug Administration (FDA)

(Page 3 of 4)

Implanted Devices

When other treatments have failed, implanted devices or surgery may be effective.

In a 30-minute outpatient procedure, a thick substance — made of collagen, carbon-coated beads, or other particles suspended in a solution — can be injected into the area surrounding the opening to the bladder. The substance, called a bulking agent, helps close the bladder opening to prevent leakage. Bulking agents are approved to treat stress incontinence due to poorly functioning sphincter muscles. The collagen device is approved for both women and men; others are approved only for women.

Repeat injections of bulking agents may be needed because the body slowly eliminates the substance over time. Other potential side effects are urinary tract infection, delayed ability to urinate, painful urination, urgency, frequent urination, and blood in the urine.

When men or women with overactive bladder have failed to respond to more conservative treatments, an electrical stimulation device can be placed next to the tailbone. This "pacemaker" for the bladder is marketed as InterStim Therapy by Medtronic Inc. of Minneapolis.

The treatment requires a trial period in which a doctor surgically implants a temporary electrode in the lower back. The temporary electrode is attached by a thin wire called a lead to an external stimulation device, which patients carry with them for a few days. The device sends mild electrical pulses to the nerve that controls the bladder and surrounding muscles. Patients can try it first, says Leng. "If there's dramatic improvement, then the device is permanently implanted at a second outpatient surgery, leaving all hardware under the skin."

"In clinical studies, more than one-third of the patients did not receive the implanted device typically because they did not have significant improvement during the trial period," says Morris.

Other Surgical Treatments

Most stress incontinence in women results from the bladder dropping down, which often occurs after childbirth, according to the NIDDK. Two common surgical procedures for severe stress incontinence are retropubic suspension and sling surgery. These surgeries are usually performed in women, but can be done in men who are incontinent after removal of all or part of the prostate gland.

In retropubic suspension, the surgeon pulls the bladder up to a more normal position by sewing it to surrounding bone or tissue.

In sling surgery, the surgeon inserts a supportive strap of material (suburethral sling) to elevate the urethra and bladder neck, anchoring it to each side of the pubic bone. Slings are medical devices made from synthetic material, or they can be fashioned from donor tissue or the patient's own tissue, which is cut from the abdominal wall. Although it is a more invasive procedure, some patients prefer using their own tissue, says Roger Dmochowski, M.D., professor of urologic surgery at Vanderbilt University in Nashville, because synthetic material may erode into the urinary tract and cause infection or reduce effectiveness.

Newer techniques for sling insertion are minimally invasive, allowing for smaller incisions and shorter hospital stays. These techniques are "variations on the suburethral sling," says Leng, "and they conceptually work the same way to provide a little hammock for support to the urethra."

Another option for women with stress incontinence is the SURx Radio Frequency Bladder Neck Suspension System. This device uses electrical energy to heat and shrink stretched tissue near the bladder and urethra to tighten up the pelvic floor muscles. "It is intended to act similar to bladder suspension using slings but is less invasive," say Morris. "However, in clinical trials, it wasn't shown to be as effective as surgery."

Like any surgery, retropubic suspension and sling surgeries all have their risks, including infection, injury to the bladder or urethra, and urinary retention. "And none of these surgeries last a lifetime," says Dmochowski, adding that 10 years of effectiveness is what most treatments attempt to accomplish. "New symptoms may cause problems," he says. As a woman ages and her body changes, "pure stress incontinence may become urge incontinence."

That's what happened to Behanna.

Behanna was in her early 30s when she was diagnosed with stress incontinence. A sling surgery solved the problem for about five years, she says. Then she developed urge incontinence. Behanna tried a number of treatments, including Kegel exercises and medications, without much relief.

Desperate for a new treatment that she hadn't tried yet, Behanna sought advice from the doctors at the women's hospital where she works. "Every time a new urologist was hired, I would corner her and say, 'I've been peeing in my pants — can you help me?'"

Behanna was presented with the option of the InterStim, and in April 2005, she tried it. During the trial period before the permanent electrode and stimulator are implanted, she had some doubts. She was sore from a large incision in her upper buttock to make a pocket of tissue for the permanent stimulator to fit into. And a temporary long lead was sticking out of her body. "I had to be careful not to catch it on anything," she says.

After a week with no results, the InterStim manufacturer's representative reprogrammed the device. "The second week was better," says Behanna, and she opted for the permanent implant.

"It was all worth it," she says. "I'm so glad I did it. I feel more confident and I'm not wearing pads now." Behanna says she still has some accidents, but her condition is about 90 percent improved.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.