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: 40Years - 90Years
FEMALE
ID06197295
Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity
Led by Mackay Memorial Hospital · Updated on 2025-05-09
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates treatments for women with detrusor overactivity who did not respond to anti-muscarinic medications. It compares the effects of combining solifenacin with mirabegron against solifenacin combined with vaginal estrogen cream. The study aims to understand how these treatment combinations affect urinary symptoms and quality of life. Participants are divided into two groups: one receives solifenacin 5mg daily with vaginal conjugated equine estrogen cream twice a week, while the other takes solifenacin 5mg plus mirabegron 25mg daily. The study monitors these treatments over time to assess their impact on bladder symptoms. Women in the study will have assessments before treatment and at 1 month, 3 months, 6 months, and 1 year after starting treatment. Researchers will evaluate urinary distress, incontinence impact, and overactive bladder symptoms using questionnaires, as well as track the number of daily urination episodes, urgency, incontinence, and nighttime urination. Safety and symptom changes will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
Who Can Participate
Age: 40Years - 90Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Patients with detrusor overactivity defined by involuntary detrusor contractions during the bladder filling phase
- Patients refractory to monotherapy with anti-muscarinic drugs
- Female patients aged 40 to 90 years
You will not qualify if you...
- Postvoid urine retention before treatment
- Medical illnesses or contraindications to solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension
- History of cerebrovascular disease, thromboembolic disorders, gallbladder disease, known or suspected breast cancer, estrogen-dependent tumors, or unexplained abnormal genital bleeding
- Use of hormone replacement therapy within the past 3 months
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 - 1 year
Participants receive active treatment with either solifenacin combined with mirabegron or solifenacin with vaginal estrogen cream to manage detrusor overactivity symptoms.
Visits at baseline, 1 month, 3 months, 6 months, and 1 year after starting 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
NON_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/30644570A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder.
Linda Cardozo, Gunnar Lose, Donna McClish...
https://pubmed.ncbi.nlm.nih.gov/15453881