Back to resultsSafety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
Primary Purpose
Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
oral anti-Parkinson drugs and injection of botulinum toxin
oral anti-Parkinson's drugs
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria: 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 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
Sites / Locations
- Zhujiang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Experimental group
Control group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
urinary symptoms
frequency、urgency、noturia and urge incontinence
urodynamics
first sensation、first desire to void、strong desire to void、maximum bladder capacity
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05997043
Brief Title
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
Official Title
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The intervention group was given oral anti-Parkinson's drugs and Botox injection, while the control group was given only anti-Parkinson's drugs.
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
oral anti-Parkinson drugs and injection of botulinum toxin
Intervention Description
The experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin
Intervention Type
Drug
Intervention Name(s)
oral anti-Parkinson's drugs
Intervention Description
The control group only took oral anti-Parkinson's drugs.
Primary Outcome Measure Information:
Title
Symptom score of overactive bladder
Description
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
Time Frame
2 weeks,1month,2 month, 3 month
Secondary Outcome Measure Information:
Title
urinary symptoms
Description
frequency、urgency、noturia and urge incontinence
Time Frame
2 weeks,1month,2 month, 3 month
Title
urodynamics
Description
first sensation、first desire to void、strong desire to void、maximum bladder capacity
Time Frame
2 weeks,1month,2 month, 3 month
Title
King health score
Description
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).
Time Frame
2 weeks,1month,2 month, 3 month
Title
Urgency severity scale
Description
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.
Time Frame
2 weeks,1month,2 month, 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuzhen Zhu, Doctor
Phone
13719153239
Email
453951712@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shujuan Yang
Phone
13715657964
Email
ysjky266@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuzhen Zhu, Doctor
Organizational Affiliation
Zhujiang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shuzhen zhu
Phone
86-020-783071
Email
453951712@qq.com
12. IPD Sharing Statement
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Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
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