Botulinum toxin reduces bladder overactivity
- Trial ID
- NCT05997043
- Official Title
- Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial
- Goal
- Botulinum toxin reduces bladder overactivity
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- Zhujiang Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
- Interventions
- oral anti-Parkinson drugs and injection of botulinum toxin, oral anti-Parkinson's drugs
Plain-Language Summary
They are testing whether injecting onabotulinumtoxinA into the bladder can safely reduce overactive bladder symptoms, like urgency, frequency, and leaking, in people with Parkinson's whose symptoms are not controlled by anticholinergic drugs. OnabotulinumtoxinA blocks acetylcholine release from nerves in the bladder wall, calming involuntary detrusor muscle contractions; the injections act locally in the bladder and do not change how levodopa works in the brain, and participants remain on their usual dopaminergic medications. Adults 25 to 80 with idiopathic Parkinson's and persistent overactive bladder despite anticholinergics can join, provided they can consent and are willing to use intermittent catheterization if needed, while people with significant urinary retention, glaucoma or myasthenia gravis, prior urinary botulinum treatment, dementia, or certain meds like anticoagulants or neuromuscular blockers are excluded.
Locations
- Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying oral anti-Parkinson drugs and injection of botulinum toxin. They are testing whether injecting onabotulinumtoxinA into the bladder can safely reduce overactive bladder symptoms, like urgency, frequency, and leaking, in people with Parkinson's whose symptoms are not controlled by anticholinergic drugs. OnabotulinumtoxinA blocks acetylcholine release from nerves in the bladder wall, calming involuntary detrusor muscle contractions; the injections act locally in the bladder and do not change how levodopa works in the brain, and participants remain on their usual dopaminergic medications. Adults 25 to 80 with idiopathic Parkinson's and persistent overactive bladder despite anticholinergics can join, provided they can consent and are willing to use intermittent catheterization if needed, while people with significant urinary retention, glaucoma or myasthenia gravis, prior urinary botulinum treatment, dementia, or certain meds like anticoagulants or neuromuscular blockers are excluded.
- Who can participate?
- Participants must be between 25 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 10 months.