Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of
frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur
at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from
this disease, they are also prone to development of benign prostatic hyperplasia (BPH) and
consequent associated lower urinary tract dysfunction. Similarly the over 65-year age group
develop spontaneous overactive bladder up to a prevalence of 30% of both men and women. The
urologic disorder is exceedingly devastating in reducing the quality of life in these
individuals due to the lower urinary tract symptoms and ultimate urinary incontinence in a
high proportion of patients.
While attempts at pharmacologic treatment are partially satisfactory many patients are
intolerant of oral drugs.
Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in
reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of
neurogenic bladder causes of over activity . The treatment procedure of injecting the
detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks
to the patient, and can be performed as an office urologic procedure.
This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A
injections into the bladder to improve urinary symptoms in 20 patients.
Phase:
Phase 4
Details
Lead Sponsor:
Stanford University
Collaborator:
Allergan
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA