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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Sung reported receiving grants from the National Institute of Child Health and Human Development (NICHD), National Institute on Aging (NIA), and Patient-Centered Outcomes Research Institute (PCORI). Dr Borello-France reported receiving grants from the NICHD. Dr Newman reported receiving grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and editorial fees from Digital Science Press. Dr Richter reported receiving grants from the NICHD, PCORI through Brown University, Renovia, the National Institutes of Health (NIH) through Washington University, and the NICHD, and other support from BlueWind Medical and UpToDate. Dr Lukacz reported receiving grants from the NICHD, the NIDDK, Boston Scientific, and Cogentix/Uroplasty, personal fees from Axonics, and other support from UpToDate. Dr Moalli reported receiving grants from Boston Scientific, the NIH, the NICHD, the Department of Defense, and Caldera. Dr Weidner reported receiving grants from the NIH and other support from UroCure. Dr Smith reported receiving editorial fees for a section in Gray's Anatomy. Dr Dunivan reported receiving grants from the NIDDK, NICHD, and Viveve and travel reimbursement for work for American College of Obstetricians and Gynecologists and American Board of Obstetrics and Gynecology. Dr Ridgeway reported receiving grants from the NICHD and personal fees from Coloplast Inc and Ethicon Inc. Dr Nguyen reported receiving grants from the NIDDK, Boston Scientific, and the NICHD. Dr Mazloomdoost reported receiving grants from Boston Scientific and being an employee of the NIH. Dr Carper reporting receiving grants from the NICHD. Dr Gantz reported receiving grants from the NICHD. No other disclosures were reported.

Figures

Figure 1.. Screening, Randomization, Treatment, and Follow-up of Women Participating in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM) Trial

aIneligible participants are included in the adverse event analysis population. Randomized patients were determined to be ineligible during site audits based on invalid baseline bladder diaries, improper washouts from over active bladder medication, or Urogenital Distress Inventory scores. bParticipants without outcome data were included in the dichotomous re-treatment analysis and were conservatively assumed to have not been retreated.

Figure 2.. Unadjusted Reduction From Baseline in Urinary Symptoms Based on Total Score From Urogenital Distress Inventory (UDI) Long Form Total

The unadjusted change from baseline of the primary outcome of the study is shown in the analysis population at each time point after baseline by treatment group. See the Methods section for UDI total score range definitions.

Figure 3.. Kaplan-Meier Probability Curve for Additional Treatment Between Groups

The probability-of-outcome curve shows length of time after initiation of the intervention until occurrence of receiving additional treatment for any urinary symptom. There was a significant difference in survival times between the treatment groups. The median time to treatment for retreated individuals was 122 days (interquartile range [IQR], 87-210) for the combined treatment group (sling and behavioral and pelvic muscle training) and 113 days (IQR, 72-223) for the sling-only group.