Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age25-80
SponsorZhujiang Hospital
About this 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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
None
Trial design
Treatments tested in this trial
- oral anti-Parkinson drugs and injection of botulinum toxin
- oral anti-Parkinson's drugs
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov