Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019.
Deborah J Lightner, Alexander Gomelsky, Lesley Souter...
https://pubmed.ncbi.nlm.nih.gov/31039103Actively Recruiting
Phase 4
Age: 20Years - 90Years
FEMALE
ID05968885
Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Led by Mackay Memorial Hospital · Updated on 2025-05-09
300
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of botulinum toxin type A bladder injections with combined drug therapy using Mirabegron and Solifenacin in patients with detrusor overactivity. The study focuses on patients who have not responded well to single-drug treatments, specifically anti-muscarinics or beta-3 adrenoceptor agonists, to better understand symptom relief and bladder function. Participants are divided into two groups: one receiving intradetrusor onabotulinumtoxinA injections, which work by blocking nerve signals to reduce bladder muscle overactivity, and the other receiving a combination of Mirabegron and Solifenacin medications. Both treatments are evaluated over time to compare their impact on symptoms and bladder performance. Throughout the study, participants will have their urinary symptoms and quality of life assessed using questionnaires at multiple points: before treatment and at 1 month, 3 months, 6 months, and 1 year after treatment. Objective bladder function measures, such as bladder capacity and pressure during involuntary contractions, will also be monitored between 3 months and 1 year. The trial uses a randomized, double-blind design to ensure reliable comparison between the two treatment approaches.
CONDITIONS
Brief Title
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
Who Can Participate
Age: 20Years - 90Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Patients with detrusor overactivity defined by involuntary detrusor contractions during bladder filling
- Patients refractory to monotherapy with either anti-muscarinics or beta-3 adrenoceptor agonists
- Female patients aged between 20 and 90 years
You will not qualify if you...
- Postvoid urine retention before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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 1 year
Participants receive either intradetrusor onabotulinumtoxinA injection or combination pharmacotherapy with Mirabegron and Solifenacin to manage detrusor overactivity.
Visits at baseline, 1 month, 3 months, 6 months, and 1 year after treatment
Follow-up
Duration - 3 months to 1 year
Participants are monitored for urodynamic outcomes and symptom changes following treatment.
Assessments during 3 months to 1 year after treatment
Trial Site Locations
Total: 1 location
1
Mackay Memorial Hospital
Taipei, Taiwan
Actively Recruiting
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Research Team
H
Hui-Hsuan Lau, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study.
Elizabeth R Mueller, Rob van Maanen, Christopher Chapple...
https://pubmed.ncbi.nlm.nih.gov/30644570The Efficacy and Safety Between Intradetrusor OnabotulinumtoxinA Injection and Combined Pharmacotherapy in Patients With Refractory Overactive Bladder: A Randomized Controlled Trial.
Meng-Hsuen Hsieh, Jiun-Chyi Hwang, Tsung-Hsien Su...
https://pubmed.ncbi.nlm.nih.gov/40590342