Actively Recruiting
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
Led by Zhujiang Hospital · Updated on 2023-08-18
60
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with idiopathic Parkinson's disease by an experienced neurologist using International Motor Disorder Association criteria
- Have overactive bladder symptoms confirmed by a 3-day voiding diary and evaluated by OABSS score
- Male or female aged between 25 and 80 years
- Treated with dopaminergic drugs, with evaluation during wearing-off periods if applicable
- Have a history of neurogenic detrusor overactivity lasting 3 months or more, with symptoms not fully controlled by anticholinergic drugs after adequate treatment
- If taking anticholinergic drugs at baseline, must maintain a stable dose during the study; if not taking, cannot start during the study
- Willing to begin intermittent catheterization if necessary
- Provided informed consent for participation in the clinical trial
You will not qualify if you...
- Residual urine volume greater than 10 ml on bladder ultrasonography
- Having glaucoma or myasthenia gravis, making botulinum toxin unsuitable
- Require indwelling catheter or intermittent catheterization to empty the bladder
- Previous treatment with botulinum toxin for any urinary disease
- Known allergies to drugs or their ingredients
- Using drugs that affect neuromuscular transmission
- Receiving anticoagulant therapy
- Infection at the injection site
- Dementia with Parkinson's dementia scale score 73.5 or less at screening or having Parkinson's psychiatric disorder
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
S
Shuzhen Zhu, Doctor
CONTACT
S
Shujuan Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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