The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial
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 R efractory O verac...
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| Veröffentlicht in: | Contemporary clinical trials 2014-03, Vol.37 (2), p.272-283 |
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| creator | Amundsen, Cindy L Richter, Holly E Menefee, Shawn Vasavada, Sandip Rahn, David D Kenton, Kim Harvie, Heidi S Wallace, Dennis Meikle, Susie |
| description | 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 R efractory O veractive Bladder: S acral N E uromodulation vs. Bo T ulinum T oxin A ssessment (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. |
| doi_str_mv | 10.1016/j.cct.2014.01.009 |
| format | Article |
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The R efractory O veractive Bladder: S acral N E uromodulation vs. Bo T ulinum T oxin A ssessment (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. 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All rights reserved.</rights><rights>2014 Elsevier Inc. All rights reserved. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c506t-f41f1da88bc01cd3d83d56534ef130b64ada976a3f6c4206b17209db380e53f03</citedby><cites>FETCH-LOGICAL-c506t-f41f1da88bc01cd3d83d56534ef130b64ada976a3f6c4206b17209db380e53f03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1551714414000196$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24486637$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Amundsen, Cindy L</creatorcontrib><creatorcontrib>Richter, Holly E</creatorcontrib><creatorcontrib>Menefee, Shawn</creatorcontrib><creatorcontrib>Vasavada, Sandip</creatorcontrib><creatorcontrib>Rahn, David D</creatorcontrib><creatorcontrib>Kenton, Kim</creatorcontrib><creatorcontrib>Harvie, Heidi S</creatorcontrib><creatorcontrib>Wallace, Dennis</creatorcontrib><creatorcontrib>Meikle, Susie</creatorcontrib><title>The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>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 R efractory O veractive Bladder: S acral N E uromodulation vs. Bo T ulinum T oxin A ssessment (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. 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The R efractory O veractive Bladder: S acral N E uromodulation vs. Bo T ulinum T oxin A ssessment (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. 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| ispartof | Contemporary clinical trials, 2014-03, Vol.37 (2), p.272-283 |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Acetylcholine Release Inhibitors - administration & dosage Acetylcholine Release Inhibitors - therapeutic use Adult Aged Botulinum Toxins, Type A - administration & dosage Botulinum Toxins, Type A - economics Botulinum Toxins, Type A - therapeutic use Cardiovascular Cost-Benefit Analysis Female Hematology, Oncology and Palliative Medicine Humans Implantable Neurostimulators Middle Aged Onabotulinum toxin A Pelvic Floor Disorders - therapy Research Design Sacral neuromodulation Urgency urinary incontinence Urinary Bladder, Overactive - therapy Urinary Incontinence, Urge - therapy |
| title | The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial |
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