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The efficacy and safety of onabotulinumtoxinA or solifenacin compared with placebo in solifenacin-naïve patients with refractory overactive bladder : results from a multicenter, randomized, double-blind, phase 3b trial

(2017) JOURNAL OF UROLOGY. 198(1). p.167-175
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Abstract
Purpose: In this double-blind, randomized study we compared the efficacy and safety of onabotulinumtoxinA or solifenacin vs placebo in patients with overactive bladder who had urinary incontinence and an inadequate response to or were intolerant of an anticholinergic. Post hoc analysis was done to compare the effects of onabotulinumtoxinA vs solifenacin. Materials and Methods: Solifenacin naive patients were randomized to onabotulinumtoxinA 100 U, solifenacin 5 mg, (which could escalate to 10 mg at week 6 according to predefined criteria) or placebo. Patients could request treatment 2 (open label onabotulinumtoxinA) after fulfilling prespecified criteria. End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co-primaries, other urinary symptoms and quality of life, all at week 12, and adverse events. Results: The change from baseline in incontinence episodes per day was significantly greater with onabotulinumtoxinA or solifenacin vs placebo (-3.19 or -2.56, respectively, vs -1.33, both p < 0.001). The incontinence reduction was significantly greater for onabotulinumtoxinA vs solifenacin (p = 0.022). At week 12, 33.8% (vs placebo p < 0.001), 24.5% (vs placebo p = 0.028) and 11.7% of patients receiving onabotulinumtoxinA, solifenacin and placebo, respectively, were dry. After treatment 2, which was open label onabotulinumtoxinA, 43.2%, 37.6% and 41.9% of patients in the onabotulinumtoxinA, solifenacin and placebo groups, respectively, were dry. Significant improvements in other urinary symptoms and quality of life were observed for both active treatments. Urinary tract infection in 25.5% of cases and urinary retention in 6.9% were more common with onabotulinumtoxinA. Conclusions: The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.
Keywords
urinary bladder, overactive, urinary incontinence, onabotulinumtoxinA, botulinum toxins, cholinergic antagonists, QUALITY-OF-LIFE, KINGS HEALTH QUESTIONNAIRE, URINARY-INCONTINENCE, ANTICHOLINERGIC THERAPY, PERSISTENCE, SYMPTOMS, IMPACT

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MLA
Herschorn, Sender et al. “The Efficacy and Safety of onabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin-naïve Patients with Refractory Overactive Bladder : Results from a Multicenter, Randomized, Double-blind, Phase 3b Trial.” JOURNAL OF UROLOGY 198.1 (2017): 167–175. Print.
APA
Herschorn, S., Kohan, A., Aliotta, P., McCammon, K., Sriram, R., Abrams, S., Lam, W., et al. (2017). The efficacy and safety of onabotulinumtoxinA or solifenacin compared with placebo in solifenacin-naïve patients with refractory overactive bladder : results from a multicenter, randomized, double-blind, phase 3b trial. JOURNAL OF UROLOGY, 198(1), 167–175.
Chicago author-date
Herschorn, Sender, Alfred Kohan, Philip Aliotta, Kurt McCammon, Rajagopalan Sriram, Steven Abrams, Wayne Lam, and Karel Everaert. 2017. “The Efficacy and Safety of onabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin-naïve Patients with Refractory Overactive Bladder : Results from a Multicenter, Randomized, Double-blind, Phase 3b Trial.” Journal of Urology 198 (1): 167–175.
Chicago author-date (all authors)
Herschorn, Sender, Alfred Kohan, Philip Aliotta, Kurt McCammon, Rajagopalan Sriram, Steven Abrams, Wayne Lam, and Karel Everaert. 2017. “The Efficacy and Safety of onabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin-naïve Patients with Refractory Overactive Bladder : Results from a Multicenter, Randomized, Double-blind, Phase 3b Trial.” Journal of Urology 198 (1): 167–175.
Vancouver
1.
Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, et al. The efficacy and safety of onabotulinumtoxinA or solifenacin compared with placebo in solifenacin-naïve patients with refractory overactive bladder : results from a multicenter, randomized, double-blind, phase 3b trial. JOURNAL OF UROLOGY. 2017;198(1):167–75.
IEEE
[1]
S. Herschorn et al., “The efficacy and safety of onabotulinumtoxinA or solifenacin compared with placebo in solifenacin-naïve patients with refractory overactive bladder : results from a multicenter, randomized, double-blind, phase 3b trial,” JOURNAL OF UROLOGY, vol. 198, no. 1, pp. 167–175, 2017.
@article{8510137,
  abstract     = {Purpose: In this double-blind, randomized study we compared the efficacy and safety of onabotulinumtoxinA or solifenacin vs placebo in patients with overactive bladder who had urinary incontinence and an inadequate response to or were intolerant of an anticholinergic. Post hoc analysis was done to compare the effects of onabotulinumtoxinA vs solifenacin. Materials and 
Methods: Solifenacin naive patients were randomized to onabotulinumtoxinA 100 U, solifenacin 5 mg, (which could escalate to 10 mg at week 6 according to predefined criteria) or placebo. Patients could request treatment 2 (open label onabotulinumtoxinA) after fulfilling prespecified criteria. End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co-primaries, other urinary symptoms and quality of life, all at week 12, and adverse events. 
Results: The change from baseline in incontinence episodes per day was significantly greater with onabotulinumtoxinA or solifenacin vs placebo (-3.19 or -2.56, respectively, vs -1.33, both p < 0.001). The incontinence reduction was significantly greater for onabotulinumtoxinA vs solifenacin (p = 0.022). At week 12, 33.8% (vs placebo p < 0.001), 24.5% (vs placebo p = 0.028) and 11.7% of patients receiving onabotulinumtoxinA, solifenacin and placebo, respectively, were dry. After treatment 2, which was open label onabotulinumtoxinA, 43.2%, 37.6% and 41.9% of patients in the onabotulinumtoxinA, solifenacin and placebo groups, respectively, were dry. Significant improvements in other urinary symptoms and quality of life were observed for both active treatments. Urinary tract infection in 25.5% of cases and urinary retention in 6.9% were more common with onabotulinumtoxinA. 
Conclusions: The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.},
  author       = {Herschorn, Sender and Kohan, Alfred and Aliotta, Philip and McCammon, Kurt and Sriram, Rajagopalan and Abrams, Steven and Lam, Wayne and Everaert, Karel},
  issn         = {0022-5347},
  journal      = {JOURNAL OF UROLOGY},
  keywords     = {urinary bladder,overactive,urinary incontinence,onabotulinumtoxinA,botulinum toxins,cholinergic antagonists,QUALITY-OF-LIFE,KINGS HEALTH QUESTIONNAIRE,URINARY-INCONTINENCE,ANTICHOLINERGIC THERAPY,PERSISTENCE,SYMPTOMS,IMPACT},
  language     = {eng},
  number       = {1},
  pages        = {167--175},
  title        = {The efficacy and safety of onabotulinumtoxinA or solifenacin compared with placebo in solifenacin-naïve patients with refractory overactive bladder : results from a multicenter, randomized, double-blind, phase 3b trial},
  url          = {http://dx.doi.org/10.1016/j.juro.2017.01.069},
  volume       = {198},
  year         = {2017},
}

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