News Release

New outpatient surgery is helping women with stress incontinence

Book Announcement

Washington University in St. Louis

It doesn't take much to trigger a leak: sneezing, laughing, lifting a child. So the millions of Americans with stress incontinence are constantly on guard, never knowing when the next wet patch will appear.

Exercises and medication are the first line of treatment. But if they fail, surgery may be best. Many procedures have been developed, but a new outpatient procedure called TVT (tension-free vaginal tape) now is being tested on female patients. The tape forms a hammock for the bladder.

Carl G. Klutke, M.D., associate professor of urologic surgery at Washington University School of Medicine in St. Louis, reviewed his experience with TVT on April 30, 1999, at the annual meeting of the Society for Urodynamics & Female Urology in Dallas. He reported that the majority of his patients who have undergone the procedure are either cured of stress incontinence or have improved a great deal.

"So I am very optimistic that this will be a major advance in incontinence care," says Klutke, who in September 1998 became one of the first American surgeons to use TVT. His study is the largest in this country to date.

Muscle power
When you hurt your arm, you don't stand much chance of pushing someone away because your muscles can't push as hard as they are being pushed. And when the circular sphincter muscle that closes the bladder gets weakened by, say, childbirth or aging, it also doesn't stand a chance. The contents of the bladder push hard when the bladder is full and sudden movement raises intra-abdominal pressure. Unable to resist the force, the sphincter gives way, and urine spurts from the bladder.

Stress incontinence accounts for about half of the estimated 10 million cases of incontinence among American women. And whereas other forms affect mainly older women, stress incontinence also plagues young women, threatening careers, social lives and relationships with family members.

In 1996, a committee formed by the American Urologic Association reviewed outcomes of incontinence surgery. It concluded that the only effective vaginal procedure is placement of a sling beneath and around the bladder neck. The sling supports the weak sphincter muscle, helping it stay closed during coughing or straining.

The sling can be made of a patient's own connective tissue, cadaver tissue or synthetic material. But until now, slings have been permanently anchored around the urethra, usually by attachment to the pubic bone. "Often, that obstructs the bladder outlet, leading to voiding difficulties, such as frequency or urgency," Klutke says. "And many patients need a catheter after surgery, at least for a short time."

A sling made of a synthetic polymer called prolene was introduced into this country from Sweden in 1998. This TVT sling doesn't have to be permanently anchored because friction keeps its coarse mesh in place. "So the sling can move with the body to some extent," Klutke says.

Simple and safe
The sling is placed from the vagina through small incisions. Because the half-hour surgery can be performed under local anesthesia, it is much less traumatic than when a sling has to be permanently fixed. "So we feel comfortable performing the TVT procedure on patients who otherwise might not be candidates for incontinence surgery because their age or health problems preclude a general anesthetic," Klutke says.

Only one of the Klutke's patients had to stay in the hospital overnight. With the other types of slings, the hospital stay is one to two days. Patients typically are able to urinate immediately after the TVT procedure. "And they don't complain as much of urgency or frequency later on," Klutke says. Klutke has inserted TVT slings into 60 women to date. Before the procedure, 12 percent of them had grade I symptoms (leakage with heavy exertion), 41 percent had grade II symptoms (leakage with moderate exertion), and 47 percent had grade III symptoms (leakage at rest).

Klutke assessed 38 of these patients two months after their surgery dates. He found that 79 percent of them no longer were incontinent, 16 percent had grade I symptoms, and 5 percent had grade III symptoms. These outcomes are very similar to those with traditional slings.

"But the TVT procedure is a major breakthrough because it can be done under local anesthesia on outpatients, usually without the need for catheterization. We also believe it will be better than the standard sling procedures at avoiding irritating voiding symptoms," Klutke says.

He stresses that longer-term studies are needed. "But TVT promises a simple and safe answer to a difficult problem," says Klutke, who now is experimenting with a TVT sling for men.

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Editor's note: Ethicon Inc. funded a small part of this study. Also, the results of a Swedish study of the TVT procedure appeared in the April 1999 issue of the British Journal of Obstetrics and Gynecology.



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