학술논문
Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial
Document Type
Original Paper
Author
Sung, Vivian W.; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S.; Moalli, Pamela; Newman, Diane K.; Richter, Holly E.; Ridgeway, Beri; Smith, Ariana L.; Weidner, Alison C.; Meikle, Susan; Barber, Mathew D.; Jelovsek, J. Eric; Paraiso, Marie Fidela R.; Walters, Mark D.; Ridgeway, Beri; Gurland, Brooke; Zutshi, Massarat; Krishnan, Geetha; Pung, Ly; Graham, Annette; Sung, Vivian W.; Myers, Deborah L.; Rardin, Charles R.; Carberry, Cassandra; Hampton, B. Star; Wohlrab, Kyle; Meers, Ann S.; Visco, Anthony; Amundsen, Cindy; Weidner, Alison; Siddiqui, Nazema; Harm-Ernandes, Ingrid; Maddocks, Jennifer; McLean, Shantae; Richter, Holly; Markland, Alayne; Varner, R. Edward; Holley, Robert; Lloyd, L. Keith; Wilson, Tracy S.; Ballard, Alicia; McCormick, Jeannine; Willis, Velria; Saxon, Nancy; Carter, Kathy; Burge, Julie; Meikle, Susan; Nager, Charles; Albo, Michael; Lukacz, Emily; Furey, Cindy; Riley, Patricia; Columbo, JoAnn; Johnson, Sherella; Menefee, Shawn; Luber, Karl; Dyer, Keisha; Diwadkar, Gouri; Tan-Kim, Jasmine; Rogers, Rebecca G.; Komesu, Yuko; Dunivan, Gena; Jeppson, Peter; Cichowski, Sara; Miller, Christy; White, Barbara; Lee, Sue; Middendorf, Julia; Wallace, Dennis; Gantz, Marie G.; Arya, Lily; Smith, Ariana; Harve, Heidi; Andy, Uduak Umoh; Levin, Pamela; Newman, Diane K.; Wang, Mary; Thompson, Donna; Carney, Teresa; Kingslee, Michelle; Flick, Lorraine; Zyczynski, Halina; Moalli, Pam; Sutkin, Gary; Shepherd, Jonathan; Bonidie, Michael; Abo, Steven; Harrison, Janet; Geraci, Lori; Gruss, Judy; Mislanovich, Karen; Eline, Ellen; Klump, Beth; for the Pelvic Floor Disorders Network
Source
International Urogynecology Journal: Including Pelvic Floor Dysfunction. October 2016 27(10):1479-1490
Subject
Language
English
ISSN
0937-3462
1433-3023
1433-3023
Abstract
Introduction and hypothesis:Mixed 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.Methods:ESTEEM 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.Results:The 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.Conclusions:We 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.