Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
- Registration Number
- NCT04113941
- Lead Sponsor
- Medy-Tox
- Brief Summary
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 216
Inclusion Criteria
- Male and female subjects aged above 20
- Patient with overactive bladder symptoms lasting at least 6 months
Exclusion Criteria
- Patient with a history of surgery or a disease that may affect bladder function.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Normal saline, same volume with Experimental arm Neuronox® Neuronox Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites
- Primary Outcome Measures
Name Time Method The change in the daily average UI (Urinary Incontinence) episodes 12 weeks
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Neuronox®'s action in idiopathic overactive bladder (OAB) treatment?
How does Neuronox® compare to standard anticholinergic therapies for idiopathic OAB in Phase 3 trials?
Which biomarkers correlate with response to botulinum toxin A (Neuronox®) in OAB patient subgroups?
What adverse events are reported in Medy-Tox's NCT04113941 trial and how are they managed?
Are there combination therapies involving Neuronox® and anticholinergics for OAB efficacy enhancement?
Trial Locations
- Locations (1)
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital🇰🇷Seoul, Korea, Republic of