Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease

NCT05997043 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2022-KY-301-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Overactive Bladder; Onabotulinumtoxin A

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• urinary symptoms

  2 weeks,1month,2 month, 3 month

• urodynamics

  2 weeks,1month,2 month, 3 month

• King health score

  2 weeks,1month,2 month, 3 month

• Urgency severity scale

  2 weeks,1month,2 month, 3 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group

Drug: oral anti-Parkinson drugs and injection of botulinum toxin

Control group

PLACEBO COMPARATOR

Control group

Drug: oral anti-Parkinson's drugs

Interventions

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

Experimental group

oral anti-Parkinson's drugs DRUG

The control group only took oral anti-Parkinson's drugs.

Control group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.
• \) Indwelling catheter or intermittent catheterization (CIC) is needed to empty the bladder.
• \) 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Urinary Bladder, Overactive

Interventions

Antiparkinson Agents

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Dyskinesia Agents; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Shuzhen Zhu, Doctor

  Zhujiang Hospital

  STUDY DIRECTOR

Central Study Contacts

Shuzhen Zhu, Doctor

CONTACT

13719153239; 453951712@qq.com

Shujuan Yang

CONTACT

13715657964; ysjky266@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Model Details: The intervention group was given oral anti-Parkinson's drugs and Botox injection, while the control group was given only anti-Parkinson's drugs.

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 18, 2023
• Study Start: August 26, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

CN (1)