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Original Investigation
September 17, 2019

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

Author Affiliations
  • 1The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island
  • 2Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania
  • 3The Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia
  • 4Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham
  • 5The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Diego, La Jolla
  • 6Women’s Center for Bladder and Pelvic Health, Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  • 7Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina
  • 8The Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia
  • 9The Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque
  • 10Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio
  • 11The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California
  • 12Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland
  • 13Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina
JAMA. 2019;322(11):1066-1076. doi:10.1001/jama.2019.12467
Key Points

Question  Does combining perioperative behavioral and pelvic floor muscle therapy with midurethral sling result in greater improvement in mixed urinary incontinence symptoms than does a sling alone?

Findings  In this randomized clinical trial that included 480 women, incontinence symptoms (measured by the Urogenital Distress Inventory Long Form; range, 0-300 points; minimal clinically important difference, 35 points) decreased by 128.2 points in the combined therapy group and 114.7 points in the surgery alone group, resulting in a statistically significant between-group difference that did not meet the threshold for clinical importance.

Meaning  Among women with mixed urinary incontinence, the addition of perioperative behavioral and pelvic floor muscle therapy to midurethral sling surgery resulted in a difference in urinary incontinence symptoms that may not be clinically important.

Abstract

Importance  Mixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman’s quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.

Objective  To determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.

Design, Setting, and Participants  Randomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.

Interventions  Behavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).

Main Outcomes and Measures  The primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.

Results  Among 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change −128.1 points (95% CI, −146.5 to −109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change −114.7 points (95% CI, −133.3 to −96.2). The model-estimated between-group difference (−13.4 points; 95% CI, −25.9 to −1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).

Conclusions and Relevance  Among women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.

Trial Registration  ClinicalTrials.gov Identifier: NCT01959347

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