OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

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Amundsen, Cindy L

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Richter, Holly E

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Menefee, Shawn A

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Komesu, Yuko M

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Arya, Lily A

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Gregory, W Thomas

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Myers, Deborah L

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Zyczynski, Halina M

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Vasavada, Sandip

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Nolen, Tracy L

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Wallace, Dennis

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Meikle, Susan F

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United States

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2017-09-04T21:30:34Z

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2017-09-21T13:06:22Z

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2017-09-21T13:06:22Z

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2016-10-04

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Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

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https://www.ncbi.nlm.nih.gov/pubmed/27701661

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2565290

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1538-3598

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https://hdl.handle.net/10161/15567

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eng

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American Medical Association (AMA)

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JAMA

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10.1001/jama.2016.14617

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http://hdl.handle.net/10161/15442

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10161/15442

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Acetylcholine Release Inhibitors

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Aged

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Botulinum Toxins, Type A

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Female

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Humans

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Injections, Intramuscular

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Lumbosacral Plexus

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Middle Aged

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Patient Selection

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Transcutaneous Electric Nerve Stimulation

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Urinary Incontinence, Urge

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Urinary Tract Infections

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OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

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Journal article

pubs.author-url

https://www.ncbi.nlm.nih.gov/pubmed/27701661

pubs.begin-page

1366

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1374

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13

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Clinical Science Departments

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Duke

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Obstetrics and Gynecology

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Obstetrics and Gynecology, Urogynecology

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School of Medicine

pubs.publication-status

Published

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316

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