Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations
Charles W Nager, Linda Brubaker, Firouz Daneshgari, Heather J Litman, Kimberly J Dandreo, Larry Sirls, Gary E Lemack, Holly E Richter, Wendy Leng, Peggy Norton, Stephen R Kraus, Toby C Chai, Debuene Chang, Cindy L Amundsen, Anne M Stoddard, Sharon L Tennstedt, Urinary Incontinence Treatment Network, Elizabeth A Gormley, Larry Sirls, Salil Khandwala, Linda Brubaker, Kimberly Kenton, Holly E Richter, L Keith Lloyd, Michael Albo, Charles Nager, Toby C Chai, Harry W Johnson, Halina M Zyczynski, Wendy Leng, Philippe Zimmern, Gary Lemack, Stephen Kraus, Thomas Rozanski, Peggy Norton, Ingrid Nygaard, Sharon Tennstedt, Anne Stoddard, Debuene Chang, Marva Moxey-Mims, Rebekah Rasooly, Amy Arisco, Jan Baker, Diane Borello-France, Kathryn L Burgio, Ananias Diokno, Melissa Fischer, MaryPat Fitzgerald, Chiara Ghetti, Patricia S Goode, Robert L Holley, Margie Kahn, Jerry Lowder, Karl Luber, Emily Luckacz, Alayne Markland, Shawn Menefee, Pamela Moalli, Elizabeth Mueller, Pradeep Nagaraju, Kenneth Peters, Elizabeth Sagan, Joseph Schaffer, Amanda Simsiman, Robert Starr, Gary Sutkin, R Edward Varner, Laura Burr, JoAnn Columbo, Tamara Dickinson, Rosanna Dinh, Judy Gruss, Alice Howell, Chaandini Jayachandran, Kathy Jesse, D Lynn Kalinoski, Barbara Leemon, Kristen Mangus, Karen Mislanovich, Elva Kelly Moore, Caren Prather, Sylvia Sluder, Mary Tulke, Robin Willingham, Kimberly Woodson, Gisselle Zazueta-Damian, Kimberly J Dandreo, Liyuan Huang, Rose Kowalski, Heather Litman, Marina Mihova, Anne Stoddard, Kerry Tanwar, Sharon Tennstedt, Yan Xu, J Quentin Clemens, Paul Abrams, Diedre Bland, Timothy B Boone, John Connett, Dee Fenner, William Henderson, Sheryl Kelsey, Deborah J Lightner, Deborah Myers, Bassem Wadie, J Christian Winters, Charles W Nager, Linda Brubaker, Firouz Daneshgari, Heather J Litman, Kimberly J Dandreo, Larry Sirls, Gary E Lemack, Holly E Richter, Wendy Leng, Peggy Norton, Stephen R Kraus, Toby C Chai, Debuene Chang, Cindy L Amundsen, Anne M Stoddard, Sharon L Tennstedt, Urinary Incontinence Treatment Network, Elizabeth A Gormley, Larry Sirls, Salil Khandwala, Linda Brubaker, Kimberly Kenton, Holly E Richter, L Keith Lloyd, Michael Albo, Charles Nager, Toby C Chai, Harry W Johnson, Halina M Zyczynski, Wendy Leng, Philippe Zimmern, Gary Lemack, Stephen Kraus, Thomas Rozanski, Peggy Norton, Ingrid Nygaard, Sharon Tennstedt, Anne Stoddard, Debuene Chang, Marva Moxey-Mims, Rebekah Rasooly, Amy Arisco, Jan Baker, Diane Borello-France, Kathryn L Burgio, Ananias Diokno, Melissa Fischer, MaryPat Fitzgerald, Chiara Ghetti, Patricia S Goode, Robert L Holley, Margie Kahn, Jerry Lowder, Karl Luber, Emily Luckacz, Alayne Markland, Shawn Menefee, Pamela Moalli, Elizabeth Mueller, Pradeep Nagaraju, Kenneth Peters, Elizabeth Sagan, Joseph Schaffer, Amanda Simsiman, Robert Starr, Gary Sutkin, R Edward Varner, Laura Burr, JoAnn Columbo, Tamara Dickinson, Rosanna Dinh, Judy Gruss, Alice Howell, Chaandini Jayachandran, Kathy Jesse, D Lynn Kalinoski, Barbara Leemon, Kristen Mangus, Karen Mislanovich, Elva Kelly Moore, Caren Prather, Sylvia Sluder, Mary Tulke, Robin Willingham, Kimberly Woodson, Gisselle Zazueta-Damian, Kimberly J Dandreo, Liyuan Huang, Rose Kowalski, Heather Litman, Marina Mihova, Anne Stoddard, Kerry Tanwar, Sharon Tennstedt, Yan Xu, J Quentin Clemens, Paul Abrams, Diedre Bland, Timothy B Boone, John Connett, Dee Fenner, William Henderson, Sheryl Kelsey, Deborah J Lightner, Deborah Myers, Bassem Wadie, J Christian Winters
Abstract
Background and purpose: Urodynamic studies (UDS) are routinely obtained prior to surgery for stress urinary incontinence (SUI) despite a lack of evidence that UDS information has an actual impact on outcome. The primary aim of this non-inferiority randomized clinical trial is to determine whether women with symptomatic, uncomplicated SUI who undergo only a basic office evaluation (BOE) prior to SUI surgery (No UDS arm) have non-inferior treatment outcomes compared to women who have BOE and UDS (UDS arm). Secondary aims are: 1) to determine how often physicians use preoperative UDS results to alter clinical and surgical decision-making, 2) to compare the amount of improvement in incontinence outcomes, and 3) to determine the incremental cost and utility of performing UDS compared with not performing UDS.
Methods: After an initial basic office evaluation, women planning surgery for uncomplicated SUI who consent to study participation will be randomized to receive preoperative UDS or No UDS. Treatment will be planned and performed by the surgeon utilizing all the data available to them. We will compare results from the basic office evaluation (No UDS) with results from the basic office evaluation and preoperative UDS.
Results: The primary outcome will be measured at 12 months using responses to the Urogenital Distress Inventory and the Patient Global Index-Improvement.
Conclusions: Randomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges. A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach.
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Source: PubMed