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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.
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 incontinence, but without urinary tract infection or other definite symptoms pathological changes.
Bladder dysfunction is one of the most common autonomic nervous disorders in Parkinson's disease (PD). Up to 70% of PD patients have bladder hyperactivity. Nocturia is the most commonly reported symptom , followed by urinary frequency, urinary urgency and urge incontinence, affecting patients' quality of life and social life.
At present, intramuscular injection of 100U botulinum toxin (BoNT-A) is a reasonable choice for the treatment of bladder overactivity in PD, and it has been proved to be a safe and effective method for the treatment of neurogenic detrusor overactivity, especially for patients with insufficient response to anticholinergic drugs,which is a Grade Ia recommendation in the EAU guidelines.
There are some problems in the current research as follows: 1. Single-arm study, non-randomized control, and small sample size; 2. Only patients with urinary incontinence but not patients with dry bladder overactivity were included; 3. Patients with urinary retention are not excluded, resulting in urinary retention after injection of botulinum toxin, affecting the experience of patients; 4. Botulinum toxin dose injection varies, there is still a lack of large-scale prospective clinical studies to reflect the relationship between botulinum toxin dose and residual urine volume; 5. The urodynamic index was used in the outcome index, which could not reflect the improvement of symptoms sensitively and objectively. In order to make up for the shortcomings of previous studies, a randomized controlled trial is planned to confirm the efficacy and safety of intramuscular injection of low dose botulinum toxin in the treatment of PD bladder overactivity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental group |
|
| Control group | Placebo Comparator | Control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral anti-Parkinson drugs and injection of botulinum toxin | Drug | The experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom score of overactive bladder | The purpose of this questionnaire is to assess the severity of symptoms in patients with overactive bladder. Based on the OABSS scale, when the score of question 3 (urgency) is more than 2 points, and the whole OABSS score is more than 3 points, it can be diagnosed as OAB | 2 weeks,1month,2 month, 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| urinary symptoms | frequency、urgency、noturia and urge incontinence | 2 weeks,1month,2 month, 3 month |
| urodynamics | first sensation、first desire to void、strong desire to void、maximum bladder capacity |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuzhen Zhu, Doctor | Contact | 13719153239 | 453951712@qq.com | |
| Shujuan Yang | Contact | 13715657964 | ysjky266@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuzhen Zhu, Doctor | Zhujiang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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The intervention group was given oral anti-Parkinson's drugs and Botox injection, while the control group was given only anti-Parkinson's drugs.
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For Parkinson's disease patients with overactive bladder, participants were assigned to an experimental or control group in a 1:1 ratio at the end of the baseline visit.Assignment will be concealed (sealed envelopes) and randomized to either the experimental or control group using an independent online computerized randomization system. Once randomized into the study, all patients will be included in the ITT analysis
| oral anti-Parkinson's drugs | Drug | The control group only took oral anti-Parkinson's drugs. |
|
| 2 weeks,1month,2 month, 3 month |
| King health score | This questionnaire contains 9 areas, of which the general perception of health (GHP) and the severity of urination problems (SUP) contain only one problem, and the other 7 areas each contain multiple problems. The seven areas were behavioral limitation (RL), social limitation (SL), movement limitation (PL), personal life (PR), emotion (EMO), sleep / energy (SE) and urinary incontinence coping style (CM). | 2 weeks,1month,2 month, 3 month |
| Urgency severity scale | This questionnaire evaluates the degree of urination urgency. It is divided into 5 grades from 0 to 4, which are no sense of urgency, slight sense of urgency, moderate urgency, severe urgency and leakage. | 2 weeks,1month,2 month, 3 month |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000978 | Antiparkinson Agents |
| ID | Term |
|---|---|
| D018726 | Anti-Dyskinesia Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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