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International Urogynecology Journal
Published in: International Urogynecology Journal 10/2016

01-10-2016 | Special Contribution

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

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

Published in: International Urogynecology Journal | Issue 10/2016

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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.
Appendix
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Metadata
Title
Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial
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
Publication date
01-10-2016
Publisher
Springer London
Published in
International Urogynecology Journal / Issue 10/2016
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-016-3031-7

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