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A new randomized clinical trial aimed to determine whether combining behavioral and pelvic floor muscle therapy with a sling would be more effective than the surgery alone.
Women who have combined stress and urgency incontinence often end up undergoing a midurethral sling procedure but the surgery can worsen urgency. A new randomized clinical trial aimed to determine whether combining behavioral and pelvic floor muscle therapy with a sling would be more effective than the surgery alone.
Published in JAMA, the research is by authors from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. The randomized trial enrolled women aged 21 or older who had moderate or severe stress urinary incontinence (SUI) or urgency urinary incontinence symptoms for at least 3 months, and at least one SUI and urgency incontinence episode on a 3-day bladder diary.
Of the 416 women in the study-conducted at nine sites from October 2013 to April 2016-207 had a sling procedure alone and 209 had the procedure plus behavioral and pelvic floor muscle therapy. The latter therapies consisted of one visit before surgery and five postoperative visits through 6 months with trained interventionists. The sessions included education on pelvic floor anatomy, bladder function, and voiding habits; pelvic floor muscle training; bladder training; and strategies to control SUI and urgency symptoms.
The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form. The UDI is a validated patient-reported outcomes questionnaire that includes three symptom subscales: irritative symptoms, stress incontinence, and obstructive symptoms. It has a range of 0 to 300 points, with 35 points being a minimal clinically important difference and higher scores indicating worse symptoms.
At 12 months post-surgery, the authors found that the model-estimated between-group difference (-13.4 points; 95% confidence interval [CI] -25.9 to -1.0; P = .04) did not meet the minimally clinically important difference threshold. However, the UDI score in the combined group did decrease significantly from 178.0 points at baseline to 30.7 points at 12 months and in the sling-only group, it decreased significantly from 176.8 to 34.5 points.
The authors said of their results that “among women with mixed urinary incontinence, the addition of perioperative behavioral and pelvic floor muscle therapy to midurethral surgery resulted in a difference in urinary incontinence symptoms that may not be clinically important.”