We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStimsup®) therapy for refractory urgency urinary incontinence (UUI).
The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.
Written by:
Amundsen CL, Richter HE, Menefee S, Vasavada S, Rahn DD, Kenton K, Harvie HS, Wallace D, Meikle S. Are you the author?
Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA; Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Obstetrics and Gynecology, Kaiser Permanente-San Diego, San Diego, CA, USA; Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH, USA; Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, TX, USA; Department of Obstetrics & Gynecology and Urology, Stritch School of Medicine, Loyola University, Chicago, IL, USA; Department of Obstetrics & Gynecology, University of Pennsylvania, Philadelphia, PA, USA; RTI International, USA; Contraception and Reproductive Health Branch, Center for Population Research, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, USA.
Reference: Contemp Clin Trials. 2014 Jan 30;37(2):272-283.
doi: 10.1016/j.cct.2014.01.009
PubMed Abstract
PMID: 24486637
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