The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.
We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) 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 6 months, 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.
Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA. Electronic address: cindy.amundsen@duke.edu.
Cindy L
CL
Amundsen
Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL, USA.
Holly E
HE
Richter
Department of Obstetrics and Gynecology, Kaiser Permanente-San Diego, San Diego, CA, USA.
Shawn
S
Menefee
Department of Obstetrics and Gynecology, Cleveland Clinic, Cleveland, OH, USA.
Sandip
S
Vasavada
Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, TX, USA.
David D
DD
Rahn
Department of Obstetrics & Gynecology and Urology, Stritch School of Medicine, Loyola University, Chicago, IL, USA.
Kim
K
Kenton
Department of Obstetrics & Gynecology, University of Pennsylvania, Philadelphia, PA, USA.
Heidi S
HS
Harvie
RTI International, USA.
Dennis
D
Wallace
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.
Susie
S
Meikle
D065087:Acetylcholine Release Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D058542:Implantable Neurostimulators; D008875:Middle Aged; D059952:Pelvic Floor Disorders / Q000628:therapy; D012107:Research Design; D053201:Urinary Bladder, Overactive / Q000628:therapy*; D053202:Urinary Incontinence, Urge / Q000628:therapy*
D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
Onabotulinum toxin A; Sacral neuromodulation; Urgency urinary incontinence