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Recruiting EARLY_Phase 1 NCT05997043

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

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Trial Parameters

Condition Parkinson's Disease
Sponsor Zhujiang Hospital
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 60
Sex ALL
Min Age 25 Years
Max Age 80 Years
Start Date 2023-08-26
Completion 2024-07-01
Interventions
oral anti-Parkinson drugs and injection of botulinum toxinoral anti-Parkinson's drugs

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 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. 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). 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 anticholine

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