In women with mixed urinary incontinence, a combined conservative and surgical treatment approach provided significant improvements versus surgical treatment alone.
In women with mixed urinary incontinence, a combined conservative and surgical treatment approach provided significant improvements versus surgical treatment alone, according to results of a randomized clinical trial.
Compared to women who received midurethral sling alone, women who received the sling plus perioperative behavioral/pelvic floor exercise had improved quality of life and decreased need for retreatment at 12 months, it was reported at the International Continence Society annual meeting in Philadelphia.
The improvements in incontinence symptoms, while statistically significant, did not meet prespecified criteria that would suggest a clinically important difference, meaning that a combined approach could not be recommended across the board, researcher Vivian W. Sung, MD, MPH, of Brown University, Providence, RI said in an interview.
“Secondary endpoints, including retreatment rates and quality of life, were significantly better in the combined group compared to the sling-only group, so our recommendation is that these findings should be discussed with patients, and treatment should be tailored based on their input and their preferences,” said Dr. Sung.
The report by Dr. Sung and colleagues, which received the Conservative Management Award at the ICS meeting, was based on 464 participants included in the primary intention-to-treat analysis of the ESTEEM study, including 235 randomly assigned to the combined approach, and 229 to sling only.
Patients in ESTEEM had mixed urinary incontinence, defined as stress and urgency incontinence symptoms that were at least moderately bothersome. They all underwent retropubic or transobturator midurethral sling operations.
Behavioral/pelvic floor therapy sessions were conducted by trained interventionists, starting 1 month before and ending 6 months after the procedure.The standardized intervention included education on voiding habits, pelvic floor muscle and bladder training, and strategies to control urgency and reduce or prevent urinary symptoms.
Patients receiving the sling and intervention had significantly improved mixed urinary incontinence symptoms based on total Urogenital Distress Inventory (UDI) score at 12 months, the primary end-point of the study.
Next:What the authors foundTotal UDI scores decreased by 128 points in the combination arm, versus 115 points (p=.04). However, that mean difference of –13 points did not meet the published minimum important difference of –35 for the total UDI score, Dr. Sung reported.
Likewise, UDI irritative and stress subscale scores were lower in the combination group versus the sling-only group, with mean differences of –6 (p=.04) and –5.5 points (p=.08), but again, those differences did not meet the published minimum important difference criteria, she said.
Unexpectedly, the sling-only group had a marked improvement not only in stress incontinence, but also urge incontinence, which may have made it more challenging to show a clinically significant difference between groups, according Dr. Sung. The mean change in Incontinence Impact Questionnaire score from baseline to 12 months was –102 points for the sling-only group, and –132 points for combined therapy, she reported.
“Contrary to what we've thought for a long time, having a sling may significantly improve both components,” Dr. Sung said.
Several other secondary endpoints of the ESTEEM study analysis suggested a benefit of the combined approach over the sling-only approach. Bladder diary analyses showed that the total number of incontinence episodes decreased by –2.4 per day in the combined therapy arm, versus –1.4 in the sling-only arm (p<.01).
Diaries also showed that normalization of voiding frequency was noted in 74% of the combined arm and 46% of the sling-only arm (p<.001).
Only 9% of combined therapy patients needed additional urinary treatment, versus 16% of sling-only patients (p=.01), Dr. Sung added.
Taken together, these results suggest a potential for considering combined surgical-conservative treatment in consultation with patients, according to Dr. Sung.
“An individual woman may not have improvement reaching the minimum important difference, but she may still experience clinical improvement,” Dr. Sung said. “So I think that's why it's important to present the findings in a balanced way and to understand her treatment goals and preferences.”
Dr. Sung presented the results on behalf of researchers in the National Institute for Child Health and Human Development Pelvic Floor Disorders Network.