Comparing solifenacin or mirabegron with local estrogen to combined pharmacotherapy for overactive bladder
Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory 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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | Female |
| Sponsor | Mackay Memorial Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06479720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with detrusor overactivity who have not found relief from anti-muscarinic medications or mirabegron.
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.
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 performed: While there have been studies on individual treatments for overactive bladder, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Taipei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.