Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson'
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.
| Condition(s) | Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 controlle |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Lead sponsor | Zhujiang Hospital |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2023-08-26 |
| NCT ID | NCT05997043 |
| Official listing | https://clinicaltrials.gov/study/NCT05997043 |