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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Shuzhen Zhu, Doctor
453951712@qq.com
13719153239
Backup
Shujuan Yang
ysjky266@163.com
13715657964
Time Frame
Start Date: 2023-08-26
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 60
Treatments
Experimental: Experimental group
Experimental group
Placebo_comparator: Control group
Control group
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov