Actively Recruiting

Phase Not Applicable
Age: 30Years - 100Years
FEMALE
ID07025642

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

Age: 30Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with overactive bladder
Not Eligible

You will not qualify if you...

  • Diabetes mellitus (DM)
  • Cerebrovascular accident (CVA)
  • Other significant medical problems

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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