Cost Effectiveness of Behavioral and Pelvic Floor Muscle Therapy Combined With Midurethral Sling Surgery vs Surgery Alone Among Women With Mixed Urinary Incontinence: Results of the ESTEEM Randomized Trial.

Urinary incontinence is prevalent among women, and it has a significant economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence, has a greater adverse impact on quality of life and is more complex to treat compared to either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency components simultaneously are lacking.

Cost effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling surgery versus surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency symptoms on cost effectiveness was assessed.

This prospective economic evaluation was performed concurrent with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) randomized trial that was conducted from October 2013 through April 2016. Participants included 480 women with moderate-to-severe stress and urgency-incontinence symptoms and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the health care sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 U.S. dollars. Effectiveness was measured in quality-adjusted life-years (QALYs) and reductions in urinary-incontinence episodes/day. Incremental cost-effectiveness ratios of combined treatment versus midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and for the sub-group of women with Urogenital Distress Inventory-irritative scores ≥50th percentile.

Costs were higher for combined treatment versus midurethral sling surgery alone from both the health care sector perspective ($5,100[95%CI $5,000, $5,190] versus $4,470[95%CI $4,330, $4,620], p<0.01) and the societal perspective ($9,260[95%CI $8,590, $9,940] versus $8,090[95%CI $7,630, $8,560], p<0.01). There were no differences between combined treatment versus midurethral sling surgery alone in QALYs (0.87[95%CI 0.86, 0.89] versus 0.87[95%CI 0.86, 0.89], p=0.90) or mean reduction in urinary-incontinence episodes/day (-4.76[95%CI -4.51, -5.00] versus -4.50[95%CI -4.25, -4.75], p=0.13). When evaluating the overall study population, from both the health care sector and societal perspectives, midurethral sling surgery alone dominated combined treatment. The probability that combined treatment is cost effective relative to midurethral sling surgery alone is ≤28% from the health care sector and ≤19% from the societal perspectives for willingness-to-pay values ≤$150,000/QALY. For women with baseline Urogenital Distress Inventory-irritative scores ≥50th percentile, combined treatment was cost effective compared to midurethral sling surgery alone from both the health care sector and societal perspectives. The probability that combined treatment is cost effective relative to midurethral sling surgery alone for this subgroup is ≥90% from both the health care sector and societal perspectives, at willingness-to-pay values of ≥$150,000/QALY.

Overall, perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling surgery is not cost effective compared with surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment is good value compared with midurethral sling surgery alone for women with severe baseline urgency symptoms.

American journal of obstetrics and gynecology. 2021 Jul 06 [Epub ahead of print]

Heidi S Harvie, Vivian W Sung, Simon J Neuwahl, Amanda A Honeycutt, Isuzu Meyer, Christopher J Chermansky, Shawn Menefee, Whitney K Hendrickson, Gena C Dunivan, Donna Mazloomdoost, Sarah J Bass, Marie G Gantz, NICHD Pelvic Floor Disorders Network

Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; The Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA. Electronic address: ., Department of Obstetrics and Gynecology, Alpert Medical School of Brown University/Women and Infants Hospital, Providence, RI., Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, NC., Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL., Department of Urology, University of Pittsburgh, PA., Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA., Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC., Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM., Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States.