Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial

Vivian W. Sung, Diane Borello-France, Gena Dunivan, Marie G. Gantz, Emily S. Lukacz, Pamela Moalli, Diane K. Newman, Holly E. Richter, Beri Ridgeway, Ariana L. Smith, Alison C. Weidner, Susan Meikle, the Pelvic Floor Disorders Network for the Pelvic Floor Disorders Network, Marie Fidela R. Paraiso, Mathew D. Barber, Brooke Gurland, Massarat Zutshi, Geetha Krishnan, Ly Pung, Annette GrahamDeborah L. Myers, Charles R. Rardin, Cassandra Carberry, B. Star Hampton, Kyle Wohlrab, Ann S. Meers, Anthony Visco, Cindy Amundsen, Nazema Siddiqui, Ingrid Harm-Ernandes, Jennifer Maddocks, Shantae McLean, Alayne Markland, R. Edward Varner, Robert Holley, L. Keith Lloyd, Tracy S. Wilson, Alicia Ballard, Jeannine McCormick, Velria Willis, Nancy Saxon, Kathy Carter, Julie Burge, Charles Nager, Michael Albo, Cindy Furey, Patricia Riley, Jo Ann Columbo, Sherella Johnson, Shawn Menefee, Karl Luber, Keisha Dyer, Gouri Diwadkar, Jasmine Tan-Kim, Rebecca G. Rogers, Yuko Komesu, Peter Jeppson, Sara Cichowski, Christy Miller, Barbara White, Sue Lee, Julia Middendorf, Dennis Wallace, Lily Arya, Heidi Harve, Uduak Umoh Andy, Pamela Levin, Mary Wang, Donna Thompson, Teresa Carney, Michelle Kingslee, Lorraine Flick, Halina Zyczynski, Gary Sutkin, Jonathan Shepherd, Michael Bonidie, Steven Abo, Janet Harrison, Lori Geraci, Judy Gruss, Karen Mislanovich, Ellen Eline, Beth Klump

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1479-1490
Number of pages12
JournalInternational Urogynecology Journal
Volume27
Issue number10
DOIs
StatePublished - Oct 1 2016

Keywords

  • Behavioral therapy
  • Clinical trials
  • Female
  • Mixed urinary incontinence
  • Sling

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Urology

Fingerprint

Dive into the research topics of 'Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial'. Together they form a unique fingerprint.

Cite this