Comparing solifenacin or mirabegron with local estrogen to combined pharmacotherapy for overactive bladder
Official title: Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder
Run by Mackay Memorial Hospital · NCT06479720 · Data updated 2026-11-12
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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 90 Years |
| Sex | Women only |
| Enrollment | 300 (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 | NCT06479720 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with detrusor overactivity who have not found relief from anti-muscarinic medications or mirabegron.
✕Probably not a fit
Patients with contraindications to solifenacin, mirabegron, or estrogen, as well as those with postvoid urine retention, may 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 solifenacin or mirabegron combined with local estrogen compared to a combination of solifenacin and mirabegron in women suffering from overactive bladder. Participants with detrusor overactivity who did not respond to previous treatments are enrolled and divided into three groups for treatment. The study evaluates both subjective symptoms related to incontinence and objective measures such as frequency of urination and urgency. Various validated questionnaires are used to assess the impact on quality of life and urinary symptoms.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women with overactive bladder who have not responded to standard therapies.
How similar studies have gone: While there have been studies on individual treatments for overactive bladder, this specific combination approach is novel and has not been extensively tested.
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.
Where it's running
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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
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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.