Anticholinergic versus botulinum toxin A comparison trial for the treatment of bothersome urge urinary incontinence: ABC trial
Anthony G Visco, Linda Brubaker, Holly E Richter, Ingrid Nygaard, Marie Fidela Paraiso, Shawn A Menefee, Joseph Schaffer, John Wei, Toby Chai, Nancy Janz, Cathie Spino, Susan Meikle, Pelvic Floor Disorders Network, Mathew D Barber, Marie Fidela R Paraiso, Mark D Walters, J Eric Jelovsek, Linda McElrath, Donel Murphy, Cheryl Williams, Anthony G Visco, Cindy L Amundsen, Alison C Weidner, Jennifer M Wu, Mary J Raynor, Mary McGuire, Jean Maynor, Linda Brubaker, A G Visco, Kimberly Kenton, MaryPat FitzGerald, Elizabeth Mueller, Mary Tulke, Holly E Richter, Kathryn L Burgio, R Edward Varner, Robert L Holley, Patricia S Goode, L Keith Lloyd, Tracey Wilson, Alayne D Markland, Velria Willis, Nancy Saxon, LaChele Ward, Lisa S Pair, Charles W Nager, Shawn A Menefee, Emily Lukacz, Karl M Luber, Michael E Albo, Keisha Dyer, Gouri Diwadkar, Leah Merrin, Giselle Zazueta-Damian, Joseph Schaffer, Clifford Wai, Marlene Corton, David Rahn, Gary Lemack, Kelly Moore, Shanna Atnip, Margaret Hull, Pam Martinez, Deborah Lawson, Ingrid Nygaard, Peggy Norton, Yvonne Hsu, Linda Freeman, Shirley Ranke, Laura Burr, Linda Griffen, Cathie Spino, John T Wei, Beverly Marchant, Donna DiFranco, John O L DeLancey, Dee Fenner, Nancy K Janz, Wen Ye, Zhen Chen, Yang Wang Casher, Susan Meikle, Kathie Hartmann, Anthony G Visco, Linda Brubaker, Holly E Richter, Ingrid Nygaard, Marie Fidela Paraiso, Shawn A Menefee, Joseph Schaffer, John Wei, Toby Chai, Nancy Janz, Cathie Spino, Susan Meikle, Pelvic Floor Disorders Network, Mathew D Barber, Marie Fidela R Paraiso, Mark D Walters, J Eric Jelovsek, Linda McElrath, Donel Murphy, Cheryl Williams, Anthony G Visco, Cindy L Amundsen, Alison C Weidner, Jennifer M Wu, Mary J Raynor, Mary McGuire, Jean Maynor, Linda Brubaker, A G Visco, Kimberly Kenton, MaryPat FitzGerald, Elizabeth Mueller, Mary Tulke, Holly E Richter, Kathryn L Burgio, R Edward Varner, Robert L Holley, Patricia S Goode, L Keith Lloyd, Tracey Wilson, Alayne D Markland, Velria Willis, Nancy Saxon, LaChele Ward, Lisa S Pair, Charles W Nager, Shawn A Menefee, Emily Lukacz, Karl M Luber, Michael E Albo, Keisha Dyer, Gouri Diwadkar, Leah Merrin, Giselle Zazueta-Damian, Joseph Schaffer, Clifford Wai, Marlene Corton, David Rahn, Gary Lemack, Kelly Moore, Shanna Atnip, Margaret Hull, Pam Martinez, Deborah Lawson, Ingrid Nygaard, Peggy Norton, Yvonne Hsu, Linda Freeman, Shirley Ranke, Laura Burr, Linda Griffen, Cathie Spino, John T Wei, Beverly Marchant, Donna DiFranco, John O L DeLancey, Dee Fenner, Nancy K Janz, Wen Ye, Zhen Chen, Yang Wang Casher, Susan Meikle, Kathie Hartmann
Abstract
This trial compares the change in urgency urinary incontinence episodes over 6 months, tolerability and cost effectiveness between women receiving daily anticholinergic therapy plus a single intra-detrusor injection of saline versus a single intra-detrusor injection of 100 U of botulinum toxin A plus daily oral placebo tablets. We present the rationale and design of a randomized-controlled trial, Anticholinergic versus Botulinum Toxin, Comparison Trial for the Treatment of Bothersome Urge Urinary Incontinence: ABC trial, conducted by the NICHD-funded Pelvic Floor Disorders Network. We discuss the innovative nature of this trial and the challenges related to choice of patient population, maintaining masking, cost effectiveness, ethical considerations, measuring adherence, and placebo development and testing. Enrollment began in April, 2010. 242 participants will be randomized and primary outcome data analysis is anticipated to begin in mid 2012. Several challenges in the trial design are discussed. Randomization to placebo intra-detrusor injections may limit recruitment, potentially impacting generalizability. Other challenges included the heavy marketing of drugs for overactive bladder which could impact recruitment of drug-naïve women. In addition, anticholinergic medications often cause dry mouth, making masking difficult. Finally, adverse reporting of transient urinary retention is challenging as there is no standardized definition; yet this is the most common adverse event following intra-detrusor botulinum toxin injection. The ABC trial will help women with urgency urinary incontinence balance efficacy, side effects and cost of anticholinergic medication versus botulinum toxin intra-detrusor injection. The results have the potential to fundamentally change the therapeutic approach to this condition.
Trial registration: ClinicalTrials.gov NCT01166438.
Copyright © 2011 Elsevier Inc. All rights reserved.
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Source: PubMed