Status:
RECRUITING
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
Lead Sponsor:
Zhujiang Hospital
Conditions:
Parkinson's Disease
Overactive Bladder
Eligibility:
All Genders
25-80 years
Phase:
EARLY_PHASE1
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.
Detailed Description
Overactive bladder is defined by the International Continence Society as a syndrome characterized by symptoms of urinary urgency, often accompanied by frequency and nocturia, with or without urge inco...
Eligibility Criteria
Inclusion
- patients with idiopathic Parkinson's disease were diagnosed by experienced neurologists based on the diagnostic criteria of the International Motor Disorder Association.
- PD patients with overactive bladder were observed by voiding diary for 3 days and evaluated by OABSS score.
- Eligible males and females, aged between 25 and 80.
- 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).
- 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.
- 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.
- if necessary, the patient must be willing to initiate intermittent catheterization (CIC).
- 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
- 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
Key Trial Info
Start Date :
August 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05997043
Start Date
August 26 2023
End Date
July 1 2026
Last Update
August 18 2023
Active Locations (1)
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1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000