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Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease
Not Recruiting
Trial ID: NCT01421719
Purpose
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.
Official Title
Onabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and Efficacy
Stanford Investigator(s)
Eligibility
Inclusion Criteria:•
- Male or female subjects, 50 to 85 years of age.
- Patients diagnosed with Parkinson's disease prior to lower urinary tract symptoms.
- Documentation of low volume desire to void and/or unstable detrusor contractions with
or without incontinence on cystometrogram. Voiding diary consistent with overactive
bladder
- Written informed consent has been obtained.
- Ability to follow study instructions and likely to complete all required visits.
- Written authorization for Use and Release of Health and Research Study Information has
been obtained.
- Subject has minimum to moderate severity/stage of disease, Hoehn and Yahr stage IV or
less (or UPDRS equivalent)
- Usual and customary medications allowed
Exclusion Criteria:
- Uncontrolled clinically significant medical condition other than the condition under
evaluation
- Known allergy or sensitivity to any of the components in the study medication.
- Concurrent participation in another investigational drug or device study or
participation within 60 days period of time prior to study
- New anticholinergic medication. Should discontinue any anti-muscarinic medication 14
days prior to injection.
- Treatment with botulinum toxin of any serotype prior to enrollment in study (if
applicable).
- Any medical condition that may put the subject at increased risk with exposure to
BTX-A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
lateral sclerosis, or any other disorder that might interfere with neuromuscular
function (if applicable).
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition (if
applicable)
- Urinary tract infection
- Significant BPH with evidence of severe bladder trabeculation
- Greater than 50% post-void residual urine volume
- Any condition or situation that, in the investigator's opinion, may put the subject at
significant risk, confound the study results, or interfere significantly with the
subject's participation in the study.
Intervention(s):
drug: Cystoscopic injection of Botox into the urinary bladder
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305