Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence

Anthony G. Visco, Linda Brubaker, Holly E. Richter, Ingrid Nygaard, Marie Fidela R Paraiso, Shawn A. Menefee, Joseph Schaffer, Jerry Lowder, Salil Khandwala, Larry Sirls, Cathie Spino, Tracy L. Nolen, Dennis Wallace, Susan F. Meikle

Research output: Contribution to journalArticle

117 Citations (Scopus)

Abstract

Background: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. Methods: We performed a double-blind, double-placebo - controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. Results: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P = 0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P = 0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P = 0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P = 0.01) and urinary tract infections (13% vs. 33%, P<0.001). Conclusions: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections.

Original languageEnglish (US)
Pages (from-to)1803-1813
Number of pages11
JournalNew England Journal of Medicine
Volume367
Issue number19
DOIs
StatePublished - Nov 8 2012

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Cholinergic Antagonists
Urinary Incontinence
Therapeutics
Urinary Tract Infections
Injections
Mouth
Catheters
Placebos
Quality of Life
onabotulinumtoxinA
Urinary Retention
Random Allocation
Randomized Controlled Trials

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Visco, A. G., Brubaker, L., Richter, H. E., Nygaard, I., Paraiso, M. F. R., Menefee, S. A., ... Meikle, S. F. (2012). Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence. New England Journal of Medicine, 367(19), 1803-1813. https://doi.org/10.1056/NEJMoa1208872

Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence. / Visco, Anthony G.; Brubaker, Linda; Richter, Holly E.; Nygaard, Ingrid; Paraiso, Marie Fidela R; Menefee, Shawn A.; Schaffer, Joseph; Lowder, Jerry; Khandwala, Salil; Sirls, Larry; Spino, Cathie; Nolen, Tracy L.; Wallace, Dennis; Meikle, Susan F.

In: New England Journal of Medicine, Vol. 367, No. 19, 08.11.2012, p. 1803-1813.

Research output: Contribution to journalArticle

Visco, AG, Brubaker, L, Richter, HE, Nygaard, I, Paraiso, MFR, Menefee, SA, Schaffer, J, Lowder, J, Khandwala, S, Sirls, L, Spino, C, Nolen, TL, Wallace, D & Meikle, SF 2012, 'Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence', New England Journal of Medicine, vol. 367, no. 19, pp. 1803-1813. https://doi.org/10.1056/NEJMoa1208872
Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MFR, Menefee SA et al. Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence. New England Journal of Medicine. 2012 Nov 8;367(19):1803-1813. https://doi.org/10.1056/NEJMoa1208872
Visco, Anthony G. ; Brubaker, Linda ; Richter, Holly E. ; Nygaard, Ingrid ; Paraiso, Marie Fidela R ; Menefee, Shawn A. ; Schaffer, Joseph ; Lowder, Jerry ; Khandwala, Salil ; Sirls, Larry ; Spino, Cathie ; Nolen, Tracy L. ; Wallace, Dennis ; Meikle, Susan F. / Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 19. pp. 1803-1813.
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T1 - Anticholinergic therapy vs. onabotulinumtoxinA for urgency urinary incontinence

AU - Visco, Anthony G.

AU - Brubaker, Linda

AU - Richter, Holly E.

AU - Nygaard, Ingrid

AU - Paraiso, Marie Fidela R

AU - Menefee, Shawn A.

AU - Schaffer, Joseph

AU - Lowder, Jerry

AU - Khandwala, Salil

AU - Sirls, Larry

AU - Spino, Cathie

AU - Nolen, Tracy L.

AU - Wallace, Dennis

AU - Meikle, Susan F.

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N2 - Background: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. Methods: We performed a double-blind, double-placebo - controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. Results: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P = 0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P = 0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P = 0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P = 0.01) and urinary tract infections (13% vs. 33%, P<0.001). Conclusions: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections.

AB - Background: Anticholinergic medications and onabotulinumtoxinA are used to treat urgency urinary incontinence, but data directly comparing the two types of therapy are needed. Methods: We performed a double-blind, double-placebo - controlled, randomized trial involving women with idiopathic urgency urinary incontinence who had five or more episodes of urgency urinary incontinence per 3-day period, as recorded in a diary. For a 6-month period, participants were randomly assigned to daily oral anticholinergic medication (solifenacin, 5 mg initially, with possible escalation to 10 mg and, if necessary, subsequent switch to trospium XR, 60 mg) plus one intradetrusor injection of saline or one intradetrusor injection of 100 U of onabotulinumtoxinA plus daily oral placebo. The primary outcome was the reduction from baseline in mean episodes of urgency urinary incontinence per day over the 6-month period, as recorded in 3-day diaries submitted monthly. Secondary outcomes included complete resolution of urgency urinary incontinence, quality of life, use of catheters, and adverse events. Results: Of 249 women who underwent randomization, 247 were treated, and 241 had data available for the primary outcome analyses. The mean reduction in episodes of urgency urinary incontinence per day over the course of 6 months, from a baseline average of 5.0 per day, was 3.4 in the anticholinergic group and 3.3 in the onabotulinumtoxinA group (P = 0.81). Complete resolution of urgency urinary incontinence was reported by 13% and 27% of the women, respectively (P = 0.003). Quality of life improved in both groups, without significant between-group differences. The anticholinergic group had a higher rate of dry mouth (46% vs. 31%, P = 0.02) but lower rates of catheter use at 2 months (0% vs. 5%, P = 0.01) and urinary tract infections (13% vs. 33%, P<0.001). Conclusions: Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections.

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