Surgery for Initial Treatment of Moderate-to-Severe Stress UI

Results of multicenter, randomized trial show that women with moderate-to-severe stress urinary incontinence (UI) treated by surgery have higher rates of subjective and objective outcomes at 1 year compared with women treated by initial physiotherapy [N Engl J Med. 2013;369:1124-1133].

“Our findings suggest that women with stress incontinence should be counseled regarding both pelvic-floor muscle training and midurethral-sling surgery as initial treatment options,” said Julien Labrie, MD, Department of Gynecology, University Medical Center Utrecht, Netherlands, the lead investigator of the study.

Although physiotherapy is the recommended first-line treatment for stress UI, more frequent success outcomes have been reported with initial treatment with midurethral-sling surgery. To date, however, these 2 treatment approaches as first-line therapy for stress UI have not been assessed in a head-to-head study. To fill this void, Dr. Labrie and colleagues randomized 460 women with moderate-to-severe UI to initial surgery (n=230; retropubic or transobturator midurethral-sling) or physiotherapy (n=230; pelvic-floor muscle training) between March 2008 and May 2010. All women enrolled in the study were between 35 and 80 years of age and had not received treatment or undergone physiotherapy >6 months prior to randomization. Women were excluded from the study if they had undergone previous incontinence surgery or women who had concomitant stage 2 or higher pelvic-organ prolapsed.

The study's primary outcome of the study was subjective improvement in symptoms of stress UI at 12 months as measured by the Patient Global Impression of Improvement (PGI-I) instrument.

Based on an intent-to-treat analysis, the study showed a significantly higher rate of subjective improvement reported in the surgery group compared to the physiotherapy group (90.8% vs 64.4%; absolute difference of 26.4 percentage points; 95% confidence interval [CI], 18.1-34.5]; P<0.001).

Women in the surgery group also had significantly higher rates of subjective cure (85.2% vs 53.4%; absolute difference of 31.8 percentage points; 95% CI, 22.6-40.3; P<.001) and objective cure (76.5% vs 58.8%; absolute difference of 17.8 percentage points; 95% CI, 7.9-27.3; P<.001).

Serious adverse events included bladder perforation (n=6), vaginal epithelial perforation (n=8), reoperation for tape exposure (n=5), and reoperation to loosen tape (n=1).

The study also permitted a crossover between groups, and 49% of women in the physiology group crossed over to the surgery group, while 11% of women in the surgery group crossed over to the physiology group. Overall, 103 women underwent only physiotherapy, 99 underwent surgery after physiotherapy, and 215 underwent initial surgery.

At 12 months, women who underwent only physiotherapy reported lower rates of subjective improvement than women in the physiotherapy group who crossed over into the surgery group (absolute difference of 61.8 percentage points) or women who underwent initial surgery (absolute difference of 59.1 percentage points). Similarly, women who underwent only physiotherapy also had higher rates of subjective and objective cure.

These results show that women with moderate-to-severe stress UI treated by surgery have significantly better subjective and objective outcomes at 12 months compared to women treated with physiotherapy alone.