Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial

Trial ID: NCT05997043

Interventional - Phase 1 - Unknown status

A randomized controlled trial is to be conducted to confirm the efficacy and safety of intramuscular injection of botulinum toxin in the treatment of Parkinson's bladder overactivity.

Conditions

• Parkinson's Disease
• Overactive Bladder
• Onabotulinumtoxin A

Interventions

• oral anti-Parkinson drugs and injection of botulinum toxin
• oral anti-Parkinson's drugs

Eligibility

Inclusion criteria

• 4. The patient was treated with dopaminergic drugs, and if there was an wearing-off phenomenon, it was evaluated during the turning-off period or without taking the drug (when the patient developed one of the symptoms in WOQ-19 \[13\] and the symptom improved after the next medication, it suggested that there was an end-of-dose phenomenon).
• 1. patients with idiopathic Parkinson's disease were diagnosed by experienced neurologists based on the diagnostic criteria of the International Motor Disorder Association.
• 2. PD patients with overactive bladder were observed by voiding diary for 3 days and evaluated by OABSS score.
• 3. Eligible males and females, aged between 25 and 80.
• 5. With a history of NDO ≥ 3 months, the symptoms of bladder overactivity were not fully controlled by anticholinergic drugs, which was defined as insufficient response after 4 weeks of treatment or unbearable side effects after 2 weeks of optimized dose treatment.
• 6. patients who took anticholinergic drugs at baseline must maintain a stable dose throughout the study, while those who did not take anticholinergic drugs could not take them during the study period.
• 7. if necessary, the patient must be willing to initiate intermittent catheterization (CIC).
• 8. the informed consent of the subject or his guardian has been obtained, and the informed consent of the clinical trial has been signed voluntarily.

Exclusion criteria

• 1\) Ultrasonography showed that the residual urine of bladder was larger than 10ml. 2) Patients with glaucoma and myasthenia gravis are not suitable for botulinum toxin.
• 3\) Indwelling catheter or intermittent catheterization (CIC) is needed to empty the bladder.
• 4\) Patients have been treated with botulinum toxin for any urinary disease. 5) People who are known to be allergic or allergic to drugs and their ingredients 6) Take drugs that interfere with neuromuscular transmission. 7) Receiving anticoagulant therapy. 8) There is infection at the injection site. 9)With dementia, Parkinson's dementia scale ≤ 73.5 at screening time \[15\] or with Parkinson's disease psychiatric disorder

Sponsor

Zhujiang Hospital

Source: ClinicalTrials.gov

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