Combining behavioral and pelvic floor muscle therapy with midurethral sling surgery does not meaningfully improve mixed urinary incontinence (UI) symptoms more than surgery alone, according to new study findings published in JAMA.
In a study of 480 women in the ESTEEM (Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary) trial, Vivian W. Sung, MD, MPH, of Women and Infants Hospital of Rhode Island in Providence, and her colleagues observed no clinically important difference in mixed UI symptoms between combination therapy and sling-only patients at 12 months after surgery based on the Urogenital Distress Inventory (UDI). The UDI, a validated patient questionnaire, includes 3 symptom subscales (irritative symptoms, stress incontinence, and obstructive symptoms) and yields scores of 0 to 300 points, with higher scores indicating worse symptoms.
In the combination therapy group, mean UDI score declined significantly from 178.0 points at baseline to 30.7 points at 12 months. In the sling-only group, mean UDI score significantly fell from 176.8 at baseline to 34.5 points at 12 months. A model-estimated between-group difference was −13.4 points, which was far short of the minimal clinically important difference threshold of 35 points, according to the investigators.
Guidelines and recommendations have previously cautioned that surgery could worsen the urgency component of mixed UI. Yet both groups in this study underwent surgery and experienced reductions in urgency symptoms and had a low rate (12%) of undergoing additional urinary treatments, Dr Sung and the team reported. Worsening urgency incontinence occurred in 4.5% of the combination group and 2.1% of the sling-only group.
The investigators recorded adverse events in 10.2% of patients overall (8.7% in the combined and 11.8% in the sling-only groups), but just 2.3% of adverse events were considered related to the interventions. Vaginal mesh exposure occurred in 1.7% of the combination therapy group and 0.4% of the sling-only group. Less than 2% of each group underwent reoperation.
The 480 women in the ESTEEM trial, who had a mean age of 54 years, had moderate to severe stress and urgency UI based on 3-day bladder diaries and were randomly assigned to sling surgery and physical therapy (242 patients) or surgery only (238 patients). Both retropubic and transobturator midurethral sling techniques were allowed. Current overactive bladder medication use, however, was not permitted. For behavioral and pelvic floor muscle therapy, patients attended 1 preoperative and 5 postoperative sessions up to 6 months after surgery and received instruction from trained staff. The trial was conducted across 9 recruiting sites in the Pelvic Floor Disorders Network in the United States during October 2013 and April 2016.
“The ESTEEM trial was well done and robust and should be used to guide clinical care,” Ingrid E. Nygaard, MD, MS, of the University of Utah in Salt Lake City, wrote in an accompanying editorial. “The results are likely generalizable to women with mixed incontinence without pelvic organ prolapse.”
Dr Nygaard added: “Women with mixed incontinence can reasonably be offered a midurethral sling for stress incontinence if basic conservative therapy is not helpful in reducing symptoms. Most patients can expect marked reduction in both stress and urgency incontinence symptoms and high satisfaction at 1 year. These women can proceed with surgery alone because benefit was not shown for adding a behavioral therapy package.”
Sung VW, Borello-France D, Newman DK, et al. Effect of behavioral and pelvic floor muscle therapy combined with surgery vs surgery alone on incontinence symptoms among women with mixed urinary incontinence: The ESTEEM randomized clinical trial. JAMA. 2019;322(11):1066-1076. doi:10.1001/jama.2019.12467
Nygaard IE. Evidence-based treatment for mixed urinary incontinence. JAMA. 2019;322(11):1049-1050.