NCT01959347|CompletedPhase 3ResultsDMC
Combined Treatment for Mixed Incontinence
ESTEEM
Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)
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Sponsor study identifier
Secondary identifiers
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
NIH
interventional
480
1 country
10
Study Start
October 28, 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 9, 2017
Actual (reported)Study Completion
September 29, 2017
Actual (reported)The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population. A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2013
Actual (reported)October 10, 2013
Actual (reported)October 28, 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 9, 2017
Actual (reported)September 29, 2017
Actual (reported)May 14, 2020
Actual (reported)Change From Baseline UDI Total Score
The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
3, 6, and 12 Months
Change From Baseline UDI Stress Score
3, 6, and 12 Months
Change From Baseline UDI Irritative Score
3, 6, and 12 Months
Change From Baseline UDI Obstructive Score
3, 6, and 12 Months
Change From Baseline Number of Stress Incontinence Episodes
2 weeks and 2, 6, and 12 Months
Change From Baseline Number of Urge Incontinence Episodes
2 weeks and 2, 6, and 12 Months
Change From Baseline Number of Unknown Incontinence Episodes
2 weeks and 2, 6, and 12 Months
Miduretheral Sling (Control)
Miduretheral Sling with behavioral/pelvic floor therapy
MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health \& Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, 35249-7333, United States
Kaiser Permanente -- Downey
Downey, California, 90242, United States
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, 92037-0974, United States
Kaiser Permanente -- San Diego
San Diego, California, 92110, United States
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, 87131-0001, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707, United States
Richter HE, Carnes MU, Komesu YM, Lukacz ES, Arya L, Bradley M, Rogers RG, Sung VW, Siddiqui NY, Carper B, Mazloomdoost D, Dinwiddie D, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence. Am J Obstet Gynecol. 2022 Jan;226(1):93.e1-93.e15. doi: 10.1016/j.ajog.2021.07.008. Epub 2021 Jul 21.
Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; NICHD Pelvic Floor Disorders Network. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2021 Aug 1;138(2):199-207. doi: 10.1097/AOG.0000000000004444.
Vivian W. Sung
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Dennis Wallace
RTI International
480 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2013
First Posted
October 10, 2013
Study Start
October 28, 2013
Date type not reportedThis date has not been verified as actual or estimated.
Urinary Stress Incontinence and Urgency in Women With EMSELLA
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Cleveland Clinic, Department OB/GYN
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Magee-Womens Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, 15213, United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, 02903, United States
Sung VW, Richter HE, Moalli P, Weidner AC, Nguyen JN, Smith AL, Dunivan G, Ridgeway B, Borello-France D, Newman DK, Mazloomdoost D, Carper B, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network*. Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence. Obstet Gynecol. 2020 Sep;136(3):482-491. doi: 10.1097/AOG.0000000000003989.
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 Sep 17;322(11):1066-1076. doi: 10.1001/jama.2019.12467.
Primary Completion
August 9, 2017
Actual (reported)Study Completion
September 29, 2017
Actual (reported)Last Updated
May 14, 2020
Results First Posted
May 14, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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