Stress Incontinence: Surgery Beats Physiotherapy

Laird Harrison

September 19, 2013

Some women with stress urinary incontinence may fare better if they skip physiotherapy and go directly to midurethral sling surgery, according to results from a new study.

In a head-to-head trial of the 2 approaches, 90.8% of women assigned to surgery reported improvement a year later compared with 64.4% of those assigned to physiotherapy.

The study, by Julien Labrie, MD, from the University Medical Center Utrecht, the Netherlands, and other researchers at multiple centers in the Netherlands appears in the September 19 issue of the New England Journal of Medicine.

Professional guidelines for treating stress urinary incontinence typically call for women to try physiotherapy, in which they learn to control their pelvic floor muscles before proceeding to surgery.

Most prior studies have found higher rates of success for the surgery. In this study, surgeons used by transobturator and retropubic techniques to place polypropylene tape.

Synthetic mesh used in this type of surgery has caused controversy in recent years. In October 2008, the US Food and Drug Administration (FDA) issued a safety communication warning of potential problems with a mesh often used in the procedure.

In July 2011, the FDA updated the notice, saying that "serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare," and that the FDA "continues to evaluate the effects of using surgical mesh to repair stress urinary incontinence and will communicate these findings at a later date."

To measure the effectiveness of the 2 approaches, the researchers recruited 460 women with moderate to severe stress urinary incontinence. Some had undergone physiotherapy 6 months or longer before, but none had prior surgery for incontinence.

The researchers randomly assigned half of the participants to receive physiotherapy and half to surgery. Some dropped out, and ultimately, 202 took the physiotherapy training, with 196 available at 12-month follow-up. Meanwhile, 215 underwent surgery, of whom 174 were available for follow-up. Those who were not satisfied with physiotherapy could cross over to surgery, and 99 women made that transition.

In an intention-to-treat analysis, looking at the outcomes in the 2 groups as they were originally assigned, the researchers found that women who had the surgery were 26.4% more likely to report improvement than women who had physiotherapy (95% confidence interval [CI], 18.1 - 34.5%; P < .001).

The rate of objective cure was 76.5% for the surgery group vs 58.8% for the physiotherapy group, a difference of 17.8 percentage points (95% CI, 7.9 - 27.3) in the intention-to-treat analysis.

In a per protocol analysis, the investigators analyzed outcomes for patients according to 3 regimens: those who had physiotherapy only, those who crossed over to surgery after physiotherapy, and those who started the study with surgery.

In the physiotherapy group, 31.7% of participants reported improvement, and 15.9% said they were cured. By objective measures, 44.0% were considered cured. (The difference between the objective and subjective measures of cure could have to do with occasional incontinence in circumstances that were not measured objectively, the authors note.)

Of the women who had surgery after physiotherapy, 93.5% reported improvement and 87.0% reported a cure, whereas 71.8% were considered cured by objective measures.

In the initial surgery group, 90.8% reported improvement, 85.2% reported a cure, and 76.5% were considered cured by objective measures.

The difference in outcomes among the groups in the per protocol analysis was statistically significant (P < .001) in favor of surgery.

The women who underwent physiotherapy alone did not experience any adverse events. Of those who had surgery, including those who crossed over from the physiotherapy group, 41 experienced adverse events. Serious adverse events included 6 bladder perforations, 10 vaginal epithelial perforations, 6 reoperations for tape exposure, and 1 operation to loosen tape.

"Our findings suggest that women with this condition should be counseled regarding both pelvic-floor muscle training and midurethral-sling surgery as initial treatment options," the authors conclude.

They acknowledge that their sample could be biased, however, as some women might have participated in hopes of avoiding physiotherapy.

"[T]here are a number of studies that show that physiotherapy can be very effective" for stress urinary incontinence, American Urology Association spokesperson Tomas Griebling, MD, from the University of Kansas in Kansas City, told Medscape Medical News.

He pointed out another weakness in the study: all the patients knew what kind of treatment they got, so some patients might have benefited from a placebo effect. "There is no way to blind the patients in this sort of study," he said.

Still, he suggested the findings contribute to what is known about the relative effectiveness of the procedures, as few if any head-to-head trials have taken place before.

The study was supported by a grant from ZonMw, the Netherlands Organization for Health Research and Development. The authors and Dr. Griebling have disclosed no relevant financial relationships.

N Engl J Med. 2013;369:1124-1133. Abstract


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