Among women who had moderate to severe stress urinary incontinence, those who underwent midurethral-sling surgery as the first line of treatment showed significantly more improvement 1 year later than did women whose initial treatment was physiotherapy, according to a report published online Sept. 18 in the New England Journal of Medicine.
In a randomized Dutch trial involving 460 patients, 49 experienced gynecologists and urologists, and 83 certified pelvic physiotherapists, 1-year rates of both subjective and objective improvement, as well as rates of subjective and objective cure, were markedly higher for women who had immediate surgery than for those who had immediate physiotherapy, reported Dr. Julien Labrie of the University of Utrecht (the Netherlands) Medical Center and his associates.
Improvement in all secondary outcomes also was significantly better with initial surgery than with initial physiotherapy. These included urogenital symptoms, disease-specific quality of life, and the development of new urinary symptoms. However, all 65 adverse events that occurred in the study were related to surgery, including intraoperative bladder perforations, vaginal epithelial perforations, excessive blood loss, and four cases in which reoperation was required.
"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. Information on expected outcomes with both interventions, as well as on the potential, albeit infrequent, complications of surgery, will allow for individualized decision making by each woman and her health care provider," the investigators noted.
Dr. Labrie and his colleagues performed this study because standard practice is to recommend physiotherapy as first-line treatment, and to proceed to surgery only if that fails. Yet outcomes from midurethral-sling surgery and physiotherapy have never been directly compared.
Their study involved women aged 35-80 years whose stress urinary incontinence was classified as moderate or severe according to the Sandvik index. These subjects were randomly assigned to receive either initial surgery (230 women) or initial physiotherapy (230 women) at four university medical centers and 19 general hospitals over a 2-year period.
Both retropubic and transobturator midurethral-sling surgical approaches were allowed. Physiotherapy included an average of nine sessions delivered over 18 weeks, and could include biofeedback assistance or functional electrostimulation therapy.
The women were allowed to cross over to the other group if they were not satisfied with their assigned treatment, as "is consistent with usual clinical practice." The data were analyzed on an intention-to-treat basis. However, because approximately half of the physiotherapy group crossed over to surgery after a mean of 31 weeks, the investigators also performed a post hoc per-protocol analysis.
The primary outcome was subjective improvement in symptoms of stress urinary incontinence at 12 months, as measured by the Patient Global Impression of Improvement (PGI-I) scale. In the intention-to-treat analysis, the rate of this outcome was 90.8% with immediate surgery, significantly higher than the 64.4% rate with immediate physiotherapy, Dr. Labrie and his associates reported (New Engl. J. Med. 2013;369:1124-33 [doi: 10.1056/NEJMoa1210627]).
The pattern was the same when outcomes were assessed objectively using a cough stress test.
Both study groups showed improvement over time in urogenital symptoms as measured by the Urogenital Distress Inventory (UDI) and in disease-specific quality of life as measured by the Incontinence Impact Questionnaire (IIQ). The improvements were significantly greater in the immediate-surgery group for incontinence and overactive bladder, "but with only moderate effect sizes," the authors said.
Similarly, improvements were significantly greater in the immediate-surgery group for subscores regarding patients’ mobility and embarrassment, "but again with only moderate effect sizes," the researchers said.
In the post hoc per-protocol analysis, they compared the 103 women who only had physiotherapy, the 99 who had physiotherapy but crossed over to surgery, and the 215 who only had surgery. At 1 year, improvement in the physiotherapy-only group was lower by approximately 62% than in the crossover group and by 59% in the surgery-only group.
Adverse events, which occurred only in women who underwent surgery, included 6 cases of bladder perforation, 10 cases of vaginal epithelial perforation, 6 reoperations for tape exposure, 1 reoperation to loosen a too-tight synthetic sling, 20 hematomas, 18 cases of new-onset urge urinary incontinence, and 3 cases of excessive blood loss.
This study may have been limited by selection bias, because "women with a preference for surgery may have been more likely to participate in the study, because they otherwise would have received initial physiotherapy according to Dutch guidelines," Dr. Labrie and his associates said.
The study was supported by the Netherlands Organization for Health Research and Development (ZonMW) and was performed "without the support or involvement of manufacturers of midurethral slings." Several coauthors reported financial ties to Ethicon, American Medical Systems, and AMS. The remainder of the authors reported no relevant financial conflicts of interest.