ESTEEM

Up to 50% of the women who seek help for urinary incontinence (or accidental leakage of urine) have a condition called Mixed Urinary Incontinence (MUI). MUI as the name suggests is a combination of two common types of incontinence:

1. Stress Urinary Incontinence (SUI) which is the leakage of urine with activities such as coughing, sneezing, laughing, lifting things, or exercise.
2. Urgency Urinary Incontinence (UUI) which is leakage of urine associated with a sudden need or urge to urinate. Often women leak urine on the way to the bathroom.

Mixed urinary incontinence is a challenging condition to treat because the two causes require two treatment approaches. We know that many women continue to have bothersome urinary symptoms even after pursuing treatment. Women have reported that this type of combination incontinence is more bothersome than having either condition alone. Clinicians and the patients they treat are often frustrated with the treatment of MUI because current treatments only address well one of the types of incontinence.

Treatment strategies focused on addressing the most bothersome symptom. Sometimes this is difficult for women to identify. These treatments include:

1. Medications: these are helpful for the urgency component of leakage symptoms. Women often discontinue these medications due to side effects, continued leakage or cost.
2. Behavioral Therapy / Pelvic Floor Therapy: Working with a physical therapist or specialist in pelvic floor muscle and behavioral therapy has been shown to be helpful for all types of incontinence. This type of therapy provides advice on how much to drink, what bladder irritants to avoid, when to urinate and how to avoid situations that result in leakage. It also includes pelvic floor muscle therapy, designed to strengthen and improve coordination of the pelvic floor muscles to control leakage.
3. Midurethral surgery (‘sling’, TVT, TOT): This outpatient surgery has been shown to be highly successful in the treatment of stress incontinence symptoms. More recent evidence has shown that it may also be helpful in improving the urgency component of mixed urinary incontinence. In this surgery, a small strap of permanent mesh is placed under the urethra (or the tube that drains the bladder when women urinate).

The ESTEEM study was designed to study whether combining surgery and behavioral/pelvic floor therapy works better for treating MUI compared to having a sling alone. Women in this study had decided with their doctor to proceed with a sling surgery for their urinary incontinence. They were randomly assigned to receive either the sling surgery alone, or the sling surgery plus behavioral / pelvic floor therapy. Women attended behavioral / physical therapy visits without cost before and after surgery. All women were asked about their symptoms for one year after their surgery. The bladder symptoms of women in both groups will be compared one year after surgery.

ESTEEM started enrolling women in the Fall of 2013 and concluded in Fall of 2017. Detailed results of the ESTEEM study are presented in the publications below.

STUDY RESULTS

Sung VW, Borello-France D, Dunivan G, Gantz M, Lukacz ES, Moalli P, Newman DK, Richter HE, Ridgeway B, Smith AL, Weidner AC, Meikle S, Pelvic Floor Disorders Network. Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial. International urogynecology journal. 2016 Oct; 27(10): 1479-90.

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Sung VW, Borello-France D, Newman DK, Richter HE, Lukacz ES, Moalli P, Weidner AC, Smith AL, Dunivan G, Ridgeway B, Nguyen JN, Mazloomdoost D, Carper B, Gantz MG, NICHD Pelvic Floor Disorders Network. 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. JAMA. 2019 09; 322(11): 1066-1076.

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Newman DK, Borello-France D, Sung VW. Structured behavioral treatment research protocol for women with mixed urinary incontinence and overactive bladder symptoms. Neurourology and urodynamics. 2018 01; (): .

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Komesu YM, Dinwiddie DL, Richter HE, Lukacz ES, Sung VW, Siddiqui NY, Zyczynski HM, Ridgeway B, Rogers RG, Arya LA, Mazloomdoost D, Levy J, Carper B, Gantz MG, NICHD Pelvic Floor Disorders Network. Defining the Relationship Between Vaginal and Urinary Microbiomes. Am. J. Obstet. Gynecol.. 2019 Aug; (): .

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ClinicalTrials.gov

Read more about this study at clinicaltrials.gov.