OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.
dc.contributor.author | Amundsen, Cindy L | |
dc.contributor.author | Richter, Holly E | |
dc.contributor.author | Menefee, Shawn A | |
dc.contributor.author | Komesu, Yuko M | |
dc.contributor.author | Arya, Lily A | |
dc.contributor.author | Gregory, W Thomas | |
dc.contributor.author | Myers, Deborah L | |
dc.contributor.author | Zyczynski, Halina M | |
dc.contributor.author | Vasavada, Sandip | |
dc.contributor.author | Nolen, Tracy L | |
dc.contributor.author | Wallace, Dennis | |
dc.contributor.author | Meikle, Susan F | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2017-09-04T21:30:34Z | |
dc.date.accessioned | 2017-09-21T13:06:22Z | |
dc.date.available | 2017-09-21T13:06:22Z | |
dc.date.issued | 2016-10-04 | |
dc.description.abstract | 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. | |
dc.identifier | ||
dc.identifier | 2565290 | |
dc.identifier.eissn | 1538-3598 | |
dc.identifier.uri | ||
dc.language | eng | |
dc.publisher | American Medical Association (AMA) | |
dc.relation.ispartof | JAMA | |
dc.relation.isversionof | 10.1001/jama.2016.14617 | |
dc.relation.replaces | ||
dc.relation.replaces | 10161/15442 | |
dc.subject | Acetylcholine Release Inhibitors | |
dc.subject | Aged | |
dc.subject | Botulinum Toxins, Type A | |
dc.subject | Female | |
dc.subject | Humans | |
dc.subject | Injections, Intramuscular | |
dc.subject | Lumbosacral Plexus | |
dc.subject | Middle Aged | |
dc.subject | Patient Selection | |
dc.subject | Transcutaneous Electric Nerve Stimulation | |
dc.subject | Urinary Incontinence, Urge | |
dc.subject | Urinary Tract Infections | |
dc.title | OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. | |
dc.type | Journal article | |
pubs.author-url | ||
pubs.begin-page | 1366 | |
pubs.end-page | 1374 | |
pubs.issue | 13 | |
pubs.organisational-group | Clinical Science Departments | |
pubs.organisational-group | Duke | |
pubs.organisational-group | Obstetrics and Gynecology | |
pubs.organisational-group | Obstetrics and Gynecology, Urogynecology | |
pubs.organisational-group | School of Medicine | |
pubs.publication-status | Published | |
pubs.volume | 316 |
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