Comparing two treatments for women with overactive bladder
Official title: Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity
Run by Mackay Memorial Hospital · NCT06197295 · Data updated 2026-11-12
This study tests whether a combination of two medications or a medication with vaginal estrogen cream helps women with overactive bladder feel better and have fewer symptoms.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 90 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Mackay Memorial Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | June 16, 2022 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 9, 2025 |
| Trial ID | NCT06197295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with detrusor overactivity who have not responded to previous anti-muscarinic therapy.
✕Probably not a fit
Patients with contraindications to solifenacin, mirabegron, or estrogen therapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of combined pharmacotherapy using solifenacin and mirabegron compared to solifenacin with vaginal estrogen cream in women suffering from detrusor overactivity. Women who have not responded to anti-muscarinic treatments are enrolled and divided into two groups to receive one of the two treatment regimens. The study evaluates both subjective outcomes, such as quality of life and symptom distress, and objective outcomes, including changes in urinary frequency and incontinence episodes. The goal is to determine which treatment provides better relief from symptoms.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from detrusor overactivity.
How similar studies have gone: Other studies have explored similar pharmacotherapy combinations, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with anti-muscarinics were enrolled for prospective study. Exclusion Criteria: * Postvoid urine retention before treatment * Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension * Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding. * Women who were on hormone replacement therapy within 3 months were also excluded from the study
Where it's running
-
Mackay Memorial Hospital
Taipei, Taiwan Recruiting
Study contacts
- Principal investigator: Hui-Hsuan Lau, MD — Mackay Memorial Hospital
- Study coordinator: Hui-Hsuan Lau, MD
- Email: huihsuan1220@gmail.com
- Phone: +886-2-25433535
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing solifenacin or mirabegron with local estrogen to combined pharmacotherapy for overactive bladder
This study is testing whether combining solifenacin or mirabegron with local estrogen works better than just using solifenacin and mirabegron alone for women with overactive bladder who haven't found relief from other treatments.
-
Comparing Botox injections to combined medication for overactive bladder
This study is testing whether Botox injections or a mix of two medications can help people with overactive bladder who haven't found relief from other treatments.
-
Educational video before urodynamic testing to see if it lowers anxiety
This study tests whether watching a short educational video before urodynamics helps reduce anxiety for women undergoing the test.
-
Extended ambulatory bladder monitoring with the Glean Urodynamics System
This will test whether the Glean Urodynamics System can safely monitor bladder function in adults who need urodynamic testing, both during a clinic visit and for up to 24 hours at home.
-
Perineal versus intravaginal electrical stimulation for idiopathic overactive bladder in women
This study will test whether adding intravaginal or perineal electrical stimulation to bladder training helps women with idiopathic overactive bladder reduce urgency and leakage compared with bladder training alone.
-
Salbutamol effects on endurance athletes and screening for breathing limits
This study will test whether a common asthma inhaler, salbutamol, helps non-asthmatic endurance athletes who experience breathing limits during high-intensity exercise.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.