PMID- 24072665
OWN - NLM
STAT- MEDLINE
DCOM- 20140626
LR  - 20220310
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 30
IP  - 9
DP  - 2013 Sep
TI  - OnabotulinumtoxinA is effective in patients with urinary incontinence due to 
      neurogenic detrusor overactivity [corrected] regardless of concomitant 
      anticholinergic use or neurologic etiology.
PG  - 819-33
LID - 10.1007/s12325-013-0054-z [doi]
AB  - INTRODUCTION: To evaluate the efficacy and safety of onabotulinumtoxinA for the 
      treatment of neurogenic detrusor overactivity (NDO) in subpopulations of etiology 
      (multiple sclerosis [MS] or spinal cord injury [SCI]) and concomitant 
      anticholinergics (use/non-use). METHODS: Data were pooled from two double-blind, 
      placebo-controlled, pivotal, phase 3 studies including a total of 691 patients 
      with >/= 14 urinary incontinence (UI) episodes/week due to MS (n = 381) or SCI (n = 
      310). Patients received intradetrusor injections of onabotulinumtoxinA 200U (n = 
      227), 300U (n = 223), or placebo (n = 241). Change from baseline at week 6 in UI 
      episodes/week (primary endpoint), urodynamics, quality of life (QOL), and adverse 
      events (AEs) were assessed. RESULTS: Significant and similar reductions in UI 
      episodes were observed regardless of etiology or anticholinergic use: at week 6, 
      mean weekly decreases of -22.6 and -19.6 were seen in MS and SCI patients, 
      respectively, and -20.3 and -22.5 in anticholinergic users and non-users, 
      respectively, treated with onabotulinumtoxinA 200U. The 300U dose did not add to 
      the clinical efficacy in any subpopulation. Similar proportions of patients 
      achieved >/= 50% or 100% reductions in UI episodes in all subgroups. Improvements 
      in maximum cystometric capacity, maximum detrusor pressure during first 
      involuntary detrusor contraction, and QOL were significant in both etiologies and 
      were independent of anticholinergic use. The most common AEs in all groups were 
      urinary tract infection and urinary retention. CONCLUSION: Regardless of 
      concomitant anticholinergic use or etiology, onabotulinumtoxinA significantly 
      improved UI symptoms, urodynamics, and QOL in patients with UI due to NDO. 
      OnabotulinumtoxinA was well tolerated in all groups.
FAU - Ginsberg, David
AU  - Ginsberg D
AD  - Department of Urology, University of Southern California Institute of Urology, 
      1441 Eastlake Avenue, NOR 7416, Los Angeles, CA, 90033-9178, USA, 
      ginsberg@ccnt.usc.edu.
FAU - Cruz, Francisco
AU  - Cruz F
FAU - Herschorn, Sender
AU  - Herschorn S
FAU - Gousse, Angelo
AU  - Gousse A
FAU - Keppenne, Veronique
AU  - Keppenne V
FAU - Aliotta, Philip
AU  - Aliotta P
FAU - Sievert, Karl-Dietrich
AU  - Sievert KD
FAU - Brin, Mitchell F
AU  - Brin MF
FAU - Jenkins, Brenda
AU  - Jenkins B
FAU - Thompson, Catherine
AU  - Thompson C
FAU - Lam, Wayne
AU  - Lam W
FAU - Heesakkers, John
AU  - Heesakkers J
FAU - Haag-Molkenteller, Cornelia
AU  - Haag-Molkenteller C
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20130927
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Cholinergic Antagonists)
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
EIN - Adv Ther. 2014 Feb;31(2):242
MH  - Adult
MH  - Botulinum Toxins, Type A/*therapeutic use
MH  - Cholinergic Antagonists/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/*complications
MH  - Neuromuscular Agents/*therapeutic use
MH  - Spinal Cord Injuries/*complications
MH  - Treatment Outcome
MH  - Urinary Bladder
MH  - Urinary Bladder, Neurogenic/*drug therapy/etiology
MH  - Urinary Bladder, Overactive/*drug therapy/etiology
MH  - Urinary Incontinence/*drug therapy/etiology
MH  - Urodynamics
PMC - PMC3824824
EDAT- 2013/09/28 06:00
MHDA- 2014/06/27 06:00
PMCR- 2013/09/27
CRDT- 2013/09/28 06:00
PHST- 2013/07/15 00:00 [received]
PHST- 2013/09/28 06:00 [entrez]
PHST- 2013/09/28 06:00 [pubmed]
PHST- 2014/06/27 06:00 [medline]
PHST- 2013/09/27 00:00 [pmc-release]
AID - 54 [pii]
AID - 10.1007/s12325-013-0054-z [doi]
PST - ppublish
SO  - Adv Ther. 2013 Sep;30(9):819-33. doi: 10.1007/s12325-013-0054-z. Epub 2013 Sep 
      27.