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JAMA. 2019 Sep 17;322(11):1066-1076. doi: 10.1001/jama.2019.12467.

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 information

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

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.

PMID:
31529007
PMCID:
PMC6749544
[Available on 2020-03-17]
DOI:
10.1001/jama.2019.12467
[Indexed for MEDLINE]

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