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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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.