PMID- 26607743
OWN - NLM
STAT- MEDLINE
DCOM- 20171226
LR  - 20220321
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 36
IP  - 2
DP  - 2017 Feb
TI  - Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of 
      treatment in patients with neurogenic detrusor overactivity: Final results of a 
      long-term extension study.
PG  - 368-375
LID - 10.1002/nau.22934 [doi]
AB  - AIMS: To present final efficacy/safety results from a prospective, long-term 
      extension trial of onabotulinumtoxinA for urinary incontinence (UI) due to 
      neurogenic detrusor overactivity (NDO); patients received treatment for up to 4 
      years. METHODS: Patients who completed a 52-week, phase III trial of 
      onabotulinumtoxinA for NDO were eligible to enter a 3-year, multicenter, 
      open-label extension study of intradetrusor onabotulinumtoxinA (200U or 300U). 
      Patients were treated "as needed" based on their request and fulfillment of 
      prespecified qualification criteria (>/=12 weeks since previous treatment and a UI 
      episode threshold). Assessments included change from study baseline in UI 
      episodes/day (primary efficacy measure), volume/void, and Incontinence Quality of 
      Life (I-QOL) total score (week 6); duration of effect; adverse events (AEs); and 
      initiation of de novo clean intermittent catheterization (CIC). Data are 
      presented for up to six treatments. RESULTS: OnabotulinumtoxinA 200U consistently 
      reduced UI episodes/day; reductions from baseline ranged from -3.2 to -4.1 across 
      six treatments. Volume/void consistently increased, nearly doubling after 
      treatment. I-QOL improvements were consistently greater than twice the minimally 
      important difference (+11 points). Overall median duration of effect was 9.0 
      months (200U). Results were similar for onabotulinumtoxinA 300U. Most common AEs 
      were urinary tract infections and urinary retention. De novo CIC rates were 29.5, 
      3.4, and 6.0% (200U), and 43.0, 15.0, and 4.8% (300U) for treatments 1-3, 
      respectively; de novo CIC rates were 0% for treatments 4-6. CONCLUSIONS: 
      OnabotulinumtoxinA treatments consistently improve UI, volume/void, and QOL in 
      patients with UI due to NDO in this 4-year study, with no new safety signals. 
      Neurourol. Urodynam. 36:368-375, 2017. (c) 2015 The Authors. Neurourology and 
      Urodynamics Published by Wiley Periodicals, Inc.
CI  - (c) 2015 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, 
      Inc.
FAU - Kennelly, Michael
AU  - Kennelly M
AD  - Department of Urology, Carolinas Rehabilitation, Charlotte, North Carolina.
FAU - Dmochowski, Roger
AU  - Dmochowski R
AD  - Department of Urological Surgery, Vanderbilt University, Nashville, Tennessee.
FAU - Schulte-Baukloh, Heinrich
AU  - Schulte-Baukloh H
AD  - Department of Urologic Surgery, Medical School of Charite University Hospital, 
      Berlin, Germany.
FAU - Ethans, Karen
AU  - Ethans K
AD  - University of Manitoba, Winnipeg, Manitoba, Canada.
FAU - Del Popolo, Giulio
AU  - Del Popolo G
AD  - Department of Neurourology, Careggi University Hospital, Florence, Italy.
FAU - Moore, Courtenay
AU  - Moore C
AD  - Glickman Urological Institute, Cleveland Clinic, Cleveland, Ohio.
FAU - Jenkins, Brenda
AU  - Jenkins B
AD  - Allergan, Inc., Irvine, California.
FAU - Guard, Steven
AU  - Guard S
AD  - Allergan, Ltd., Marlow, United Kingdom.
FAU - Zheng, Yan
AU  - Zheng Y
AD  - Allergan, Inc., Bridgewater, New Jersey.
FAU - Karsenty, Gilles
AU  - Karsenty G
AD  - Department of Urology, Aix-Marseille Universite, Marseille, France.
CN  - 191622-094 Investigators
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20151124
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
RN  - 0 (Acetylcholine Release Inhibitors)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Acetylcholine Release Inhibitors/adverse effects/*therapeutic use
MH  - Adult
MH  - Botulinum Toxins, Type A/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Urinary Bladder, Neurogenic/*drug therapy
MH  - Urinary Bladder, Overactive/*diagnostic imaging
MH  - Urinary Incontinence/*drug therapy
OTO - NOTNLM
OT  - botulinum toxin
OT  - multiple sclerosis
OT  - neurogenic detrusor overactivity
OT  - onabotulinumtoxinA
OT  - quality of life
OT  - spinal cord injury
OT  - urinary incontinence
EDAT- 2015/11/27 06:00
MHDA- 2017/12/27 06:00
CRDT- 2015/11/27 06:00
PHST- 2015/06/11 00:00 [received]
PHST- 2015/11/09 00:00 [accepted]
PHST- 2015/11/27 06:00 [pubmed]
PHST- 2017/12/27 06:00 [medline]
PHST- 2015/11/27 06:00 [entrez]
AID - 10.1002/nau.22934 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 
      24.