Sling Surgery is More Effective than Burch for
Bladder Control in Women
In the largest and most rigorous U.S. trial comparing two traditional
operations for stress urinary incontinence (SUI) in women, a team
of urologists and urogynecologists supported by the National Institutes
of Health (NIH) has found that a sling procedure helps more women
achieve dryness than the Burch technique. The study is being released
early by the New England Journal of Medicine (NEJM) to
coincide with a presentation at the annual meeting of the American
Urological Association on May 21, 2007. Results will appear in
the May 24 print edition of NEJM.
“For the first time, we have a meticulous, relatively long-term
comparison of these common surgeries in women,” said Leroy M. Nyberg
Jr., Ph.D., M.D., director of urology research at the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “Women
who participated in this study have made it possible for many women
with stress incontinence and their doctors to make more-informed
choices based on clear benefits, risks and personal preferences.”
The Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr)
found that significantly more women with a sling made from the
patient’s own tissue and placed around the urethra for additional
support were dry, compared to women with a Burch colposuspension,
in which sutures are attached to a pelvic ligament to support the
urethra. Both approaches are illustrated below. Two years after
surgery, 47 percent of women who had the sling procedure and 38
percent who had a Burch were dry overall, including leakage that
could have been caused by urge incontinence. Considering only stress-specific
leakage, 66 percent of women with a sling and 49 percent with a
Burch procedure were dry.
SISTEr randomized 655 women with either pure SUI or a combination
of stress and urge incontinence to receive a fascial sling or a
Burch. Complete information on measures used to assess urinary
incontinence was available for 520 participants (79 percent) 24
months after surgery. Quality of life, patient satisfaction and
side effects were also studied.
While most women in the study were satisfied with the results
of treatment, those with a sling were significantly more satisfied.
Eighty-six percent with a sling were satisfied, compared to 78
percent of the Burch group.
Side effects were more common among women with slings, tempering
the positive results of the procedure. The most common side effect
was urinary tract infections, which occurred in 63 percent of women
with a sling and 47 percent of the Burch group. Women with a sling
also had more voiding problems (14 percent versus 2 percent) and
persistent urge incontinence, the loss of urine just before feeling
a strong, sudden urge to empty the bladder (27 percent versus 20
percent). Nineteen women with slings who had difficulty voiding
after treatment needed surgery to correct the problem; none in
the Burch group needed corrective surgery for voiding problems.
Stress urinary incontinence, in which coughing, laughing, sneezing,
running or lifting heavy objects causes urine to leak, is commonly
treated with surgery designed to provide additional support to
the bladder neck and urethra during increases in abdominal pressure
that occur with these kinds of activities. However, randomized,
controlled trials comparing these operations are rare. Studies
predating SISTEr were small, short-term, or less stringent about
diagnostic criteria and outcome measures, producing inconsistent
results across studies. SISTEr set a higher bar by standardizing
definitions, clinical evaluations, and surgical procedures at all
sites and by using “composite outcome measures and a more rigid
definition of success compared to other studies,” according to
the study.
SISTEr defined two levels of treatment success. Stress-specific
success required that women have no symptoms of leakage during
physical activities, no leakage during a valsalva and cough stress-test,
and no re-treatment for the problem. Overall success required that
women meet SUI-specific treatment goals, have a negative pad test
and have no leakage episodes recorded on a three-day voiding diary.
This higher bar may account for lower success rates in SISTEr
than in earlier trials, but it also “establishes a template for
conducting surgical trials for urinary incontinence and for other
urological conditions,” said John W. Kusek, Ph.D., co-director
of kidney and urology trials at NIDDK.
NIH’s National Institute of Diabetes and Digestive and Kidney
Diseases, National Institute of Child Health and Human Development
and Office of Research on Women’s Health funded the Urinary Incontinence
Treatment Network, a group of nine clinical centers and a biostatistical
center, to conduct a series of rigorous, long-term trials of common
incontinence therapies.
Urinary incontinence is a common and costly condition that reduces
quality of life for American women. NIDDK’s Urologic Diseases in
America project reports that up to three-fourths of women have
some degree of incontinence, and the direct cost of incontinence
for women was $12.4 billion in 1995.
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Sling
National
Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health |
Suspension
National
Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health |
SISTEr is the first trial completed by UITN, with two other studies
in the wings. Results of the second trial, the Behavior Enhances
Drug Reduction of Incontinence (BE-DRI), for urge incontinence,
are expected later this year. BE-DRI asked 307 women to make changes
such as emptying the bladder on a regular schedule and to practice
Kegel exercises to strengthen pelvic muscles to learn if these
common treatments would allow women to stop drug therapy and maintain
the same degree of bladder control.
The third UITN study, the Trial of Mid-Urethral Slings (TOMUS),
is recruiting patients to compare two minimally invasive surgeries
for the treatment of SUI. Both procedures include placement of
a synthetic mesh sling and have been approved by FDA for stress
incontinence. For a list of centers enrolling patients for TOMUS,
visit www.uitn.net or search
for TOMUS at www.clinicaltrials.gov.
To interview lead author Dr. Michael Albo, at the University of
California San Diego, contact Jacqueline Carr at (619) 543-6427
or JCarr@ucsd.edu.
For materials from NIDDK’s “Let's Talk About Bladder Control for
Women” campaign, visit http://kidney.niddk.nih.gov/kudiseases/pubs/bladdercontrol/index.htm.
The NIDDK, a component of the NIH, conducts and supports research
in diabetes and other endocrine and metabolic diseases; digestive
diseases, nutrition, and obesity; and kidney, urologic and hematologic
diseases. For more information about NIDDK and its programs, see www.niddk.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.
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