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

Publication ,  Journal Article
Amundsen, CL; Richter, HE; Menefee, SA; Komesu, YM; Arya, LA; Gregory, WT; Myers, DL; Zyczynski, HM; Vasavada, S; Nolen, TL; Wallace, D; Meikle, SF
Published in: JAMA
October 4, 2016

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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Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

October 4, 2016

Volume

316

Issue

13

Start / End Page

1366 / 1374

Location

United States

Related Subject Headings

  • Urinary Tract Infections
  • Urinary Incontinence, Urge
  • Transcutaneous Electric Nerve Stimulation
  • Patient Selection
  • Middle Aged
  • Lumbosacral Plexus
  • Injections, Intramuscular
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

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MLA
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Amundsen, C. L., Richter, H. E., Menefee, S. A., Komesu, Y. M., Arya, L. A., Gregory, W. T., … Meikle, S. F. (2016). OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA, 316(13), 1366–1374. https://doi.org/10.1001/jama.2016.14617
Amundsen, Cindy L., Holly E. Richter, Shawn A. Menefee, Yuko M. Komesu, Lily A. Arya, W Thomas Gregory, Deborah L. Myers, et al. “OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.JAMA 316, no. 13 (October 4, 2016): 1366–74. https://doi.org/10.1001/jama.2016.14617.
Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, et al. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366–74.
Amundsen, Cindy L., et al. “OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.JAMA, vol. 316, no. 13, Oct. 2016, pp. 1366–74. Pubmed, doi:10.1001/jama.2016.14617.
Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366–1374.
Journal cover image

Published In

JAMA

DOI

EISSN

1538-3598

Publication Date

October 4, 2016

Volume

316

Issue

13

Start / End Page

1366 / 1374

Location

United States

Related Subject Headings

  • Urinary Tract Infections
  • Urinary Incontinence, Urge
  • Transcutaneous Electric Nerve Stimulation
  • Patient Selection
  • Middle Aged
  • Lumbosacral Plexus
  • Injections, Intramuscular
  • Humans
  • General & Internal Medicine
  • Female