Using botulinum toxin to treat overactive bladder in Parkinson's disease
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial
This study is testing if botulinum toxin injections can help people with Parkinson's disease who have an overactive bladder feel better when other treatments haven't worked.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05997043 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of intramuscular injections of botulinum toxin A for treating overactive bladder symptoms in patients with Parkinson's disease. The study will involve a randomized controlled design to confirm the effectiveness of this treatment approach, particularly for patients who have not responded adequately to traditional anticholinergic medications. Participants will be monitored for improvements in bladder function and overall quality of life, with a focus on addressing common symptoms such as urinary urgency and frequency.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25 to 80 with idiopathic Parkinson's disease and overactive bladder symptoms that have not been adequately managed with anticholinergic drugs.
Not a fit: Patients with urinary retention or those who do not have overactive bladder symptoms may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve bladder control and quality of life for patients with Parkinson's disease.
How similar studies have performed: Previous studies have shown that botulinum toxin is effective for treating neurogenic detrusor overactivity, suggesting potential success for this approach in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion 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 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. 7. if necessary, the patient must be willing to initiate intermittent catheterization (CIC). 8. 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 Criteria: 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
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shuzhen Zhu, Doctor
- Email: 453951712@qq.com
- Phone: 13719153239
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.