PMID- 23608668
OWN - NLM
STAT- MEDLINE
DCOM- 20140207
LR  - 20220410
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 64
IP  - 2
DP  - 2013 Aug
TI  - OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder 
      symptoms and quality of life in patients with overactive bladder and urinary 
      incontinence: a randomised, double-blind, placebo-controlled trial.
PG  - 249-56
LID - S0302-2838(13)00355-2 [pii]
LID - 10.1016/j.eururo.2013.04.001 [doi]
AB  - BACKGROUND: Overactive bladder (OAB) syndrome with urinary incontinence (UI) is 
      prevalent in the population and impairs health-related quality of life (HRQOL). 
      OBJECTIVE: To assess the impact on efficacy, safety, and HRQOL of 
      onabotulinumtoxinA (BOTOX((R)), Allergan, Inc.) treatment in patients with OAB with 
      UI. DESIGN, SETTING, AND PARTICIPANTS: This pivotal, multicentre, double-blind, 
      randomised, placebo-controlled, phase 3 study enrolled patients with idiopathic 
      OAB with >/= 3 urgency UI episodes over 3 d and >/= 8 micturitions per day who were 
      inadequately managed by anticholinergics. INTERVENTION: OnabotulinumtoxinA at a 
      100U dose (n=277) or placebo (n=271), administered as 20 intradetrusor injections 
      of 0.5 ml. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Co-primary end points 
      were change from baseline in the number of UI episodes per day and proportion of 
      patients reporting positive treatment response on the treatment benefit scale 
      (TBS) at week 12. Additional end points included other OAB symptoms (episodes of 
      urinary urgency incontinence, micturition, urgency, and nocturia) and HRQOL 
      (Incontinence Quality of Life [I-QOL], King's Health Questionnaire [KHQ]). Safety 
      assessments included adverse events (AEs), postvoid residual (PVR) urine volume, 
      and initiation of clean intermittent catheterisation (CIC). RESULTS AND 
      LIMITATIONS: OnabotulinumtoxinA significantly decreased UI episodes per day at 
      week 12 (-2.95 for onabotulinumtoxinA versus -1.03 for placebo; p<0.001). 
      Reductions from baseline in all other OAB symptoms were also significantly 
      greater following onabotulinumtoxinA compared with placebo (p </= 0.01). Patients 
      perceived a significant improvement in their condition, as measured by patients 
      with a positive treatment response on the TBS (62.8% for onabotulinumtoxinA 
      versus 26.8% for placebo; p<0.001). Clinically meaningful improvements from 
      baseline in all I-QOL and KHQ multi-item domains (p<0.001 versus placebo) 
      indicated positive impact on HRQOL. AEs were mainly localised to the urinary 
      tract. Mean PVR was higher in the onabotulinumtoxinA group (46.9 ml versus 10.1 
      ml at week 2; p<0.001); 6.9% of onabotulinumtoxinA patients versus 0.7% of 
      placebo patients initiated CIC. CONCLUSIONS: OnabotulinumtoxinA 100 U was well 
      tolerated and demonstrated significant and clinically relevant improvements in 
      all OAB symptoms, patient-reported benefit, and HRQOL in patients inadequately 
      managed by anticholinergics. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00910520.
CI  - Copyright (c) 2013 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Chapple, Christopher
AU  - Chapple C
AD  - Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@shef.ac.uk
FAU - Sievert, Karl-Dietrich
AU  - Sievert KD
FAU - MacDiarmid, Scott
AU  - MacDiarmid S
FAU - Khullar, Vik
AU  - Khullar V
FAU - Radziszewski, Piotr
AU  - Radziszewski P
FAU - Nardo, Christopher
AU  - Nardo C
FAU - Thompson, Catherine
AU  - Thompson C
FAU - Zhou, Jihao
AU  - Zhou J
FAU - Haag-Molkenteller, Cornelia
AU  - Haag-Molkenteller C
LA  - eng
SI  - ClinicalTrials.gov/NCT00910520
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130410
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Cholinergic Antagonists)
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
CIN - Eur Urol. 2013 Aug;64(2):257-9. PMID: 23731721
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/administration & dosage/adverse effects/*therapeutic use
MH  - Cholinergic Antagonists/therapeutic use
MH  - Double-Blind Method
MH  - Europe
MH  - Female
MH  - Humans
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/administration & dosage/adverse effects/*therapeutic use
MH  - *Quality of Life
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Urinary Bladder/*drug effects/innervation/physiopathology
MH  - Urinary Bladder, Overactive/diagnosis/*drug therapy/physiopathology/psychology
MH  - Urinary Incontinence, Urge/diagnosis/*drug therapy/physiopathology/psychology
MH  - Urination/drug effects
MH  - Urodynamics/drug effects
OTO - NOTNLM
OT  - Botulinum toxin
OT  - OnabotulinumtoxinA
OT  - Overactive bladder
OT  - Urinary incontinence
EDAT- 2013/04/24 06:00
MHDA- 2014/02/08 06:00
CRDT- 2013/04/24 06:00
PHST- 2013/03/06 00:00 [received]
PHST- 2013/04/01 00:00 [accepted]
PHST- 2013/04/24 06:00 [entrez]
PHST- 2013/04/24 06:00 [pubmed]
PHST- 2014/02/08 06:00 [medline]
AID - S0302-2838(13)00355-2 [pii]
AID - 10.1016/j.eururo.2013.04.001 [doi]
PST - ppublish
SO  - Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 
      10.