Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's Disease
Condition: Parkinson's Disease; Neurogenic Bladder; Urinary Incontinence; Clostridium Botulinum Toxin Adverse Reaction
MeSH terms: Parkinson Disease; Urinary Bladder, Neurogenic; Urinary Incontinence; Enuresis
Intervention: Cystoscopic injection of Botox into the urinary bladder
Intervention description: 100 U of Botox A injected transurethrally into the urinary bladder muscle and submucosa.
Intervention MeSH terms: Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Neurogenic Bladder; Urinary Incontinence; botulinum toxin; cystoscopy; Effect of Other Parasympatholytics [Anticholinergics and Antimuscarinics] and Spasmolytics

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.
    

Eligibility 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.