Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial |
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| Authors: | Vivian W. Sung Diane Borello-France Gena Dunivan Marie Gantz Emily S. Lukacz Pamela Moalli Diane K. Newman Holly E. Richter Beri Ridgeway Ariana L. Smith Alison C. Weidner Susan Meikle for the Pelvic Floor Disorders Network |
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| Affiliation: | 1.The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology,Alpert Medical School of Brown University,Providence,USA;2.Women and Infants Hospital of Rhode Island Division of Urogynecology and Reconstructive Pelvic Surgery,Warren Alpert Medical School of Brown University,Providence,USA;3.Department of Physical Therapy, Rangos School of Health Sciences,Duquesne University,Pittsburgh,USA;4.The Division of Urogynecology, Department of Obstetrics and Gynecology,University of New Mexico,Albuquerque,USA;5.Social, Statistical, & Environmental Sciences,RTI International,Research Triangle Park,USA;6.The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Reproductive Medicine,UC San Diego Health System,San Diego,USA;7.Women’s Center for Bladder and Pelvic Health, Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Urogynecology and Reconstructive Pelvic Surgery,University of Pittsburgh Medical Center,Pittsburgh,USA;8.The Division of Urology, Department of Surgery,University of Pennsylvania Health System,Philadelphia,USA;9.Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology,University of Alabama at Birmingham,Birmingham,USA;10.Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women’s Health Institute,Cleveland Clinic,Cleveland,USA;11.Division of Urogynecology, Department of Obstetrics and Gynecology,Duke University Medical Center,Durham,USA;12.Eunice Kennedy Shriver National Institute of Child Health and Human Development,Bethesda,USA |
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| Abstract: | Introduction and hypothesisMixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.MethodsESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment.ResultsThe final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized.ConclusionsWe describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making. |
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