Status:
COMPLETED
Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Allergan
Conditions:
Parkinson's Disease
Neurogenic Bladder
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief 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 advanc...
Detailed Description
This open-label pilot study will evaluate the safety and efficacy of intra-detrusor injections of botulinum-A toxin (BTX-A) in 20 male or female patients with Parkinson's disease and neurogenic overac...
Eligibility Criteria
Inclusion
- •
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01421719
Start Date
February 1 2009
End Date
July 1 2011
Last Update
March 10 2017
Active Locations (1)
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1
Stanford University Hospital and Clinics
Stanford, California, United States, 94305