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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
oral anti-Parkinson drugs and injection of botulinum toxin
DrugThe experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin
oral anti-Parkinson's drugs
DrugThe control group only took oral anti-Parkinson's drugs.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
2 weeks,1month,2 month, 3 monthSecondary outcomes
1
urinary symptoms
frequency、urgency、noturia and urge incontinence
Time frame
2 weeks,1month,2 month, 3 month2
urodynamics
first sensation、first desire to void、strong desire to void、maximum bladder capacity
Time frame
2 weeks,1month,2 month, 3 month3
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).
Time frame
2 weeks,1month,2 month, 3 month4
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.
Time frame
2 weeks,1month,2 month, 3 monthSponsors and contacts
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Source ClinicalTrials.gov