Refractory idiopathic urge urinary incontinence and botulinum A injection.
OBJECTIVE
We compared 200 U intradetrusor botulinum toxin A vs placebo in women with refractory idiopathic urge incontinence.


METHODS
This institutional review board approved, multicenter registered trial randomized women with refractory urge incontinence, detrusor overactivity incontinence and 6 or greater urge incontinence episodes in 3 days to botulinum toxin A or placebo at a 2:1 ratio. Refractory was defined as inadequate symptom control after 2 or more attempts at pharmacotherapy and 1 or more other first line therapies for detrusor overactivity incontinence. The primary outcome measure was time to failure, as evidenced by a Patient Global Impression of Improvement score of 4 or greater at least 2 months after injection, or changes in treatment (initiation or increase) at any time after injection. Safety data, including increased post-void residual volume, defined as more than 200 ml irrespective of symptoms, was obtained at specified time points.


RESULTS
Approximately 60% of the women who received botulinum toxin A had a clinical response based on the Patient Global Impression of Improvement. The median duration of their responses was 373 days, significantly longer than the 62 days or less for placebo (p <0.0001). In the botulinum toxin A group increased post-void residual urine (12 of 28 women or 43%) and urinary tract infection in those with increased post-void residual urine (9 of 12 or 75%) exceeded expected ranges. Further injections were stopped after 43 patients were randomized, including 28 to botulinum toxin A and 15 to placebo.


CONCLUSIONS
Local injection of 200 U botulinum toxin A was an effective and durable treatment for refractory overactive bladder. However, a transient post-void residual urine increase was experienced in 43% of patients. Botulinum toxin A for idiopathic overactive bladder is still under investigation.
Brubaker
Linda
L
Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, Illinois 60153, USA. Lbrubaker@lumc.edu
Richter
Holly E
HE
Visco
Anthony
A
Mahajan
Sangeeta
S
Nygaard
Ingrid
I
Braun
Thomas M
TM
Barber
Matthew D
MD
Menefee
Shawn
S
Schaffer
Joseph
J
Weber
Anne M
AM
Wei
John
J
D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007267:Injections; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D014549:Urinary Incontinence / Q000188:drug therapy*
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A