Parkinson's DiseaseEarly Phase 1NCT05997043
Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
A Early Phase 1 study testing oral anti-Parkinson drugs and injection of botulinum toxin and oral anti-Parkinson's drugs in people with Parkinson's Disease and Overactive Bladder, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
- What is being tested?
- oral anti-Parkinson drugs and injection of botulinum toxin and oral anti-Parkinson's drugs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2023to 1 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
shuzhen zhu, 86-020-783071, 453951712@qq.com
About this study
Official title: Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial
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.
Read the 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
- Conditions
- Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
- Being tested
- oral anti-Parkinson drugs and injection of botulinum toxin, oral anti-Parkinson's drugs
- Medical subject headings
- Parkinson Disease, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral anti-Parkinson drugs and injection of botulinum toxinDrug
The experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin
oral anti-Parkinson's drugsDrug
The control group only took oral anti-Parkinson's drugs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group Receives: Drug: oral anti-Parkinson drugs and injection of botulinum toxin |
| Control group | Placebo comparator | Control group Receives: Drug: oral anti-Parkinson's drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks,1month,2 month, 3 month
Secondary outcomes (4)
urinary symptoms
frequency、urgency、noturia and urge incontinence
Measured: 2 weeks,1month,2 month, 3 month
urodynamics
first sensation、first desire to void、strong desire to void、maximum bladder capacity
Measured: 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).
Measured: 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.
Measured: 2 weeks,1month,2 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start26 Aug 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuzhen Zhu, Zhujiang Hospital
- Investigators
- Shuzhen Zhu, Doctor, Study director, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997043
- Sponsor's protocol ID
- 2022-KY-301-02
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05997043
- Acronym / sponsor ID
- 2022-KY-301-02
- Conditions
- Parkinson's Disease, Overactive Bladder, Onabotulinumtoxin A
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 26 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: oral anti-Parkinson drugs and injection of botulinum toxinExperimental group |
| Control group | Placebo comparator | Drug: oral anti-Parkinson's drugsControl group |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral anti-Parkinson drugs and injection of botulinum toxinThe experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin | Drug | Experimental group |
| oral anti-Parkinson's drugsThe control group only took oral anti-Parkinson's drugs. | Drug | Control group |
Primary outcome
Symptom score of overactive bladder
Time frame: 2 weeks,1month,2 month, 3 month
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
4 secondary outcomes
urinary symptoms
Time frame: 2 weeks,1month,2 month, 3 month
urodynamics
Time frame: 2 weeks,1month,2 month, 3 month
King health score
Time frame: 2 weeks,1month,2 month, 3 month
Urgency severity scale
Time frame: 2 weeks,1month,2 month, 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuzhen Zhu, Doctor study director
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing oral anti-Parkinson drugs and injection of botulinum toxin and oral anti-Parkinson's drugs in people with Parkinson's Disease and Overactive Bladder, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuzhen Zhu, Doctor (13719153239, 453951712@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom score of overactive bladder (time frame: 2 weeks,1month,2 month, 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.