Randomized Controlled Trial

. 2016 Oct;27(10):1479-90.

doi: 10.1007/s00192-016-3031-7. Epub 2016 Jun 10.

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

Collaborators, Affiliations

Collaborators

Pelvic Floor Disorders Network:
MathewD Barber, JEric Jelovsek, MarieFidela R Paraiso, MarkD Walters, Beri Ridgeway, Brooke Gurland, Massarat Zutshi, Geetha Krishnan, Ly Pung, Annette Graham, VivianW Sung, DeborahL Myers, CharlesR Rardin, Cassandra Carberry, BStar Hampton, Kyle Wohlrab, AnnS Meers, Anthony Visco, Cindy Amundsen, Alison Weidner, Nazema Siddiqui, Ingrid Harm-Ernandes, Jennifer Maddocks, Shantae McLean, Holly Richter, Alayne Markland, REdward Varner, Robert Holley, LKeith Lloyd, TracyS Wilson, Alicia Ballard, Jeannine McCormick, Velria Willis, Nancy Saxon, Kathy Carter, Julie Burge, Susan Meikle, Charles Nager, Michael Albo, Emily Lukacz, Cindy Furey, Patricia Riley, JoAnn Columbo, Sherella Johnson, Shawn Menefee, Karl Luber, Keisha Dyer, Gouri Diwadkar, Jasmine Tan-Kim, RebeccaG Rogers, Yuko Komesu, Gena Dunivan, Peter Jeppson, Sara Cichowski, Christy Miller, Barbara White, Sue Lee, Julia Middendorf, Dennis Wallace, MarieG Gantz, Lily Arya, Ariana Smith, Heidi Harve, UduakUmoh Andy, Pamela Levin, DianeK Newman, Mary Wang, Donna Thompson, Teresa Carney, Michelle Kingslee, Lorraine Flick, Halina Zyczynski, Pam Moalli, Gary Sutkin, Jonathan Shepherd, Michael Bonidie, Steven Abo, Janet Harrison, Lori Geraci, Judy Gruss, Karen Mislanovich, Ellen Eline, Beth Klump

Affiliations

¹ The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA. vsung@wihri.org.
² Women and Infants Hospital of Rhode Island Division of Urogynecology and Reconstructive Pelvic Surgery, Warren Alpert Medical School of Brown University, 101 Plain Street 5th floor, Providence, RI, 02903, USA. vsung@wihri.org.
³ Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, PA, USA.
⁴ The Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM, USA.
⁵ Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, NC, USA.
⁶ The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health System, San Diego, CA, 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, PA, USA.
⁸ The Division of Urology, Department of Surgery, University of Pennsylvania Health System, Philadelphia, PA, USA.
⁹ Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
¹⁰ Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA.
¹¹ Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
¹² Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.

PMID: 27287818
PMCID: PMC5037009
DOI: 10.1007/s00192-016-3031-7

Randomized Controlled Trial

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

Vivian W Sung et al. Int Urogynecol J. 2016 Oct.

. 2016 Oct;27(10):1479-90.

doi: 10.1007/s00192-016-3031-7. Epub 2016 Jun 10.

Authors

Collaborators

Pelvic Floor Disorders Network:
MathewD Barber, JEric Jelovsek, MarieFidela R Paraiso, MarkD Walters, Beri Ridgeway, Brooke Gurland, Massarat Zutshi, Geetha Krishnan, Ly Pung, Annette Graham, VivianW Sung, DeborahL Myers, CharlesR Rardin, Cassandra Carberry, BStar Hampton, Kyle Wohlrab, AnnS Meers, Anthony Visco, Cindy Amundsen, Alison Weidner, Nazema Siddiqui, Ingrid Harm-Ernandes, Jennifer Maddocks, Shantae McLean, Holly Richter, Alayne Markland, REdward Varner, Robert Holley, LKeith Lloyd, TracyS Wilson, Alicia Ballard, Jeannine McCormick, Velria Willis, Nancy Saxon, Kathy Carter, Julie Burge, Susan Meikle, Charles Nager, Michael Albo, Emily Lukacz, Cindy Furey, Patricia Riley, JoAnn Columbo, Sherella Johnson, Shawn Menefee, Karl Luber, Keisha Dyer, Gouri Diwadkar, Jasmine Tan-Kim, RebeccaG Rogers, Yuko Komesu, Gena Dunivan, Peter Jeppson, Sara Cichowski, Christy Miller, Barbara White, Sue Lee, Julia Middendorf, Dennis Wallace, MarieG Gantz, Lily Arya, Ariana Smith, Heidi Harve, UduakUmoh Andy, Pamela Levin, DianeK Newman, Mary Wang, Donna Thompson, Teresa Carney, Michelle Kingslee, Lorraine Flick, Halina Zyczynski, Pam Moalli, Gary Sutkin, Jonathan Shepherd, Michael Bonidie, Steven Abo, Janet Harrison, Lori Geraci, Judy Gruss, Karen Mislanovich, Ellen Eline, Beth Klump

Affiliations

¹ The Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI, USA. vsung@wihri.org.
² Women and Infants Hospital of Rhode Island Division of Urogynecology and Reconstructive Pelvic Surgery, Warren Alpert Medical School of Brown University, 101 Plain Street 5th floor, Providence, RI, 02903, USA. vsung@wihri.org.
³ Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, PA, USA.
⁴ The Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM, USA.
⁵ Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, NC, USA.
⁶ The Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health System, San Diego, CA, 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, PA, USA.
⁸ The Division of Urology, Department of Surgery, University of Pennsylvania Health System, Philadelphia, PA, USA.
⁹ Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
¹⁰ Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA.
¹¹ Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.
¹² Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.

PMID: 27287818
PMCID: PMC5037009
DOI: 10.1007/s00192-016-3031-7

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.

Keywords: Behavioral therapy; Clinical trials; Female; Mixed urinary incontinence; Sling.

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References

1. Dooley Y, Kenton K, Cao G, et al. Urinary incontinence prevalence: results from the National Health and Nutrition Examination Survey. J Urol. 2008;179:656–61. - PubMed
1. Melville JL, Katon W, Delaney K, Newton K. Urinary incontinence in US women: a population-based study. Arch Intern Med. 2005;165:537–42. - PubMed
1. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300:1311–6. - PMC - PubMed
1. Sung VW, Raker CA, Myers DL, Clark MA. Ambulatory care related to female pelvic floor disorders in the United States, 1995-2006. Am J Obstet Gynecol. 2009;201:508, e1–6. - PMC - PubMed
1. Wu JM, Kawasaki A, Hundley AF, Dieter AA, Myers ER, Sung VW. Predicting the number of women who will undergo incontinence and prolapse surgery, 2010 to 2050. Am J Obstet Gynecol. 2011;205:230, e1–5. - PMC - PubMed

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Molecular Biology Databases

Research Materials