Actively Recruiting
Outcome of Different Treatments of Overactive Bladder in Taiwan
Led by Mackay Medical College · Updated on 2025-06-17
60
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Overactive bladder (OAB) syndrome is a common condition that greatly affects patients' quality of life. This research aims to compare how three treatments—mirabegron, solifenacin, and botulinum neurotoxin type A (BoNTA)—influence bladder function, specifically looking at the mechanical work the bladder performs during urination using pressure-volume analysis (PVA). The study also explores the potential additional effects of BoNTA on bladder compliance through its impact on sympathetic nerve activity, providing deeper insight into bladder storage function. Participants will receive one of four treatments: oral solifenacin, oral mirabegron, a combination of solifenacin and mirabegron, or Botox injections. Each treatment group's bladder function will be assessed using urodynamic evaluations, including cystometry, conducted 1 month before and at 1 and 6 months after treatment. The study also includes a preclinical phase using a spinal cord injury rat model to examine these treatments' effects on bladder function in neurogenic detrusor overactivity, bridging clinical and animal research. Throughout the study, participants will undergo evaluations of bladder pressure and volume during voiding cycles, both before and several months after treatment, to measure changes in bladder work and compliance. These assessments will occur within voiding cycles lasting approximately 30 to 60 minutes. Researchers will closely monitor these outcomes to understand how each therapy affects bladder physiology. The total study period extends up to 12 months post-treatment, ensuring comprehensive follow-up and data collection.
CONDITIONS
Brief Title
Comparing Treatments for Overactive Bladder in Taiwan: A Study of Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with overactive bladder
You will not qualify if you...
- Diabetes mellitus (DM)
- Cerebrovascular accident (CVA)
- Other significant medical problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive one of the treatments for overactive bladder: oral solifenacin, oral mirabegron, combined oral solifenacin and mirabegron, or Botox injection.
Visits at 1 month before treatment and at 1 and 6 months after treatment for urodynamic evaluations
Duration - 6 to 12 months after treatment
Participants are monitored with pressure-volume and volume-pressure analyses within voiding cycles to assess bladder function after treatment.
Visits at 6 and 12 months after treatment
Trial Site Locations
Total: 1 location
1
Department of Obstetrics and Gynecology
New Taipei City, Taiwan
Actively Recruiting
Research Team
H
Hui-Hsuan Lau, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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