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Randomized Controlled Trial
. 2014 Mar;37(2):272-83.
doi: 10.1016/j.cct.2014.01.009. Epub 2014 Jan 30.

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial

Cindy L Amundsen  1 , Holly E Richter  2 , Shawn Menefee  3 , Sandip Vasavada  4 , David D Rahn  5 , Kim Kenton  6 , Heidi S Harvie  7 , Dennis Wallace  8 , Susie Meikle  9
Affiliations
Randomized Controlled Trial

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial

Cindy L Amundsen et al. Contemp Clin Trials. 2014 Mar.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01502956.

Keywords: Onabotulinum toxin A; Sacral neuromodulation; Urgency urinary incontinence.

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Figures

Figure 1
Figure 1. Study Design Diagram
Randomized, open-label, active-control, parallel-group study assessing InterStim® and Botox A®
See this image and copyright information in PMC

References

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